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Julius Mikonis

5 year, group 7

THE USE OF FLUORIDE TOOTHPASTE IN FAMILIES

OF SCHOOLCHILDREN IN KAUNAS COUNTY

Master’s Thesis

Supervisor

Prof. Julija Narbutaitė

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2 LITHUANIAN UNIVERSITY OF HEALTH SCIENCES

MEDICAL ACADEMY FACULTY OF ODONTOLOGY

CLINIC OF PREVENTIVE AND PEDIATRIC DENTISTRY

THE USE OF FLUORIDE TOOTHPASTE IN FAMILIES OF SCHOOLCHILDREN IN KAUNAS COUNTY

Master’s Thesis

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EVALUATION TABLE OF CLINICAL–EXPERIMENTAL MASTER’S THESIS Evaluation: ... Reviewer: ...

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No. MT parts MT evaluation aspects

Compliance with MT requirements and evaluation Yes Partiall y No 1 Summary (0.5 point)

Is summary informative and in compliance

with the thesis content and requirements? 0.3 0.1 0 2 Are keywords in compliance with the thesis essence? 0.2 0.1 0

3

Introduc-tion, aim and tasks (1 point)

Are the novelty, relevance and significance of the work justified in the introduction of the thesis?

0.4 0.2 0

4 Are the problem, hypothesis, aim and tasks formed clearly and properly? 0.4 0.2 0

5 Are the aim and tasks interrelated? 0.2 0.1 0

6

Review of literature (1.5 points)

Is the author’s familiarization with the works

of other authors sufficient? 0.4 0.2 0

7

Have the most relevant researches of the scientists discussed properly and are the most important results and conclusions presented?

0.6 0.3 0

8 Is the reviewed scientific literature related

enough to the topic analysed in the thesis? 0.2 0.1 0 9 Is the author’s ability to analyse and systemize

the scientific literature sufficient? 0.3 0.1 0 10

Material and methods

(2 points)

Is the research methodology explained comprehensively? Is it suitable to achieve the

set aim? 0.6 0.3 0

11

Are the samples and groups of respondents formed and described properly? Were the

selection criteria suitable? 0.6 0.3 0

12

Are other research materials and tools (questionnaires, drugs, reagents, equipment,

etc.) described properly? 0.4 0.2 0

13

Are the statistical programmes used to analyse data, the formulas and criteria used to assess the level of statistical reliability described properly?

0.4 0.2 0

14

Results (2 points)

Do the research results answer to the set aim

and tasks comprehensively? 0.4 0.2 0

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4 18 Has the statistical analysis of data been carried out properly? 0.4 0.2 0 19

Discussion (1.5 points)

Were the received results (their importance, drawbacks) and reliability of received results assessed properly?

0.4 0.2 0

20

Was the relation of the received results with the latest data of other researchers assessed properly?

0.4 0.2 0

21 Does author present the interpretation of

results? 0.4 0.2 0

22

Do the data presented in other sections (introduction, review of literature, results) repeat?

0 0.2 0.3

23

Conclu-sions (0.5 points)

Do the conclusions reflect the topic, aim and

tasks of the Master’s thesis? 0.2 0.1 0

24

Are the conclusions based on the analysed material? Do they correspond to the research

results? 0.2 0.1 0

25 Are the conclusions clear and laconic? 0.1 0.1 0

26

References (1 point)

Is the references list formed according to the

requirements? 0.4 0.2 0

27

Are the links of the references to the text correct? Are the literature sources cited correctly and precisely?

0.2 0.1 0

28 Is the scientific level of references suitable for Master’s thesis? 0.2 0.1 0 29 Do the cited sources not older than 10 years old form at least 70% of sources, and the not

older than 5 years – at least 40%?

0.2 0.1 0

Additional sections, which may increase the collected number of points

30 Annexes Do the presented annexes help to understand

the analysed topic? +0.2 +0.1 0

31

Practical

recommen-dations

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and are they related to the received results? +0.4 +0.2 0

General requirements, non-compliance with which reduce the number of points

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General

require-ments

Is the thesis volume sufficient (excluding annexes)? 15-20 pages (-2 points) <15 pages (-5 points) 33 Is the thesis volume increased artificially? points -2 -1 point

34 Does the thesis structure satisfy the requirements of Master’s thesis? -1 point -2 points 35

Is the thesis written in correct language, scientifically, logically and laconically?

-0.5 point -1 points 36 Are there any grammatical, style or computer literacy-related mistakes? points -2 -1 points

37 Is text consistent, integral, and are the volumes of its structural parts balanced?

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5 38 Amount of plagiarism in the thesis. (not evaluated) >20%

39

Is the content (names of sections and sub-sections and enumeration of pages) in compliance with the thesis structure and aims?

-0.2 point points -0.5

40

Are the names of the thesis parts in compliance with the text? Are the titles of sections and sub-sections distinguished logically and correctly?

-0.2 point -0.5 points

41 Was the permit of the Bioethical Committee received (if necessary)? -1 point 42 Are there explanations of the key terms and abbreviations (if needed)? -0.2 point points -0.5 43

Is the quality of the thesis typography (quality of printing, visual aids, binding) good?

-0.2 point points -0.5

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Reviewer’s comments: ___________________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________ _________________________________________ ___________________________

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6 TABLE OF CONTENTS SUMMARY ... 7 INTRODUCTION ... 8 1. REVIEW OF LITERATURE ... 11 1.1. Evolution of Toothpaste ... 11 1.2. Fluoride in Toothpastes ... 12

1.2.1. Pharmacokinetics of Fluoride and Fluoride Remineralisation ... 13

1.2.2. Fluoride Reservoirs in Oral Cavity ... 13

1.3. Non-fluoride Remineralisation Systems in Toothpastes ... 14

1.4. Recommended Fluoride Concentrations in Toothpastes ... 17

2. MATERIAL AND METHODS ... 20

2.1. Research design and research conditions ... 20

2.2. Study population ... 20

2.3. Research instrument ... 21

2.4. Data collection and data processing ... 21

2.5. Statistical analysis ... 21

3. RESEARCH RESULTS ... 22

3.1. Descriptive statistics of study subjects: age and place of residence ... 22

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THE USE OF FLUORIDE TOOTHPASTE IN FAMILIES OF SCHOOLCHILDREN IN KAUNAS COUNTY

SUMMARY

Relevance of the problem and aim of the thesis: In Lithuania there are still high levels of dental

caries in adults and children. The fluoride toothpastes have demonstrated high efficiency in preventing dental caries. There are no previous studies on prevalence of fluoride toothpaste use in families of schoolchildren in Kaunas County, Lithuania. The prevalence of fluoride and non-fluoride toothpaste use in various age groups and in different places of residence are not known. The aim of this study is to determine the prevalence of fluoride and non-fluoride toothpaste use in families of schoolchildren in Kaunas County.

Material and methods: This cross-sectional study was conducted in 9 schools from December 2020

to March 2021 in Kaunas County, Lithuania. Individual-level self-reported data was sourced from anonymously completed questionnaires by 233 families. The respondents were parents/guardians. The response rate was 15,05%. 13 (5,90%) questionnaires were not valid. Data concerning 220 families with 877 members (study subjects) was used in the study.

Results: 13,68% of study subjects used non-fluoride toothpaste, including 64 (12,98%) adults and 56

(14,58%) children. 166 (75,45%) families used fluoride toothpastes. Most study subjects (n=592; 67,50%) chose 1000-1450 ppm F- toothpastes for toothbrushing. In 139 (63,18%) families, adults and

children used the same toothpaste. The children of parents who use non-fluoride toothpaste also tended to use non-fluoride toothpaste (p<0,05).

Conclusions: The children used toothpastes with less fluoride concentration than the adults. The

children of parents who use non-fluoride toothpaste also tended to use non-fluoride toothpaste. The use of non-fluoride toothpaste was more prevalent in children than in adults. The families in Kaunas city used more non-fluoride toothpastes than families living in towns or villages of Kaunas County.

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8

INTRODUCTION

Dental caries is one of the most common noncommunicable chronic diseases in oral cavity of human beings [1]. The disbalance in oral microbiota causes the increased level of glycolytic acid production and lower pH values, resulting in demineralisation of hard tooth structures [2-5]. Although dental caries is largely preventable and easily treated in early stages, untreated dental caries in permanent dentition is the most common health condition, causing substantial negative influences on oral health and negative economic consequences worldwide [6, 7].

According to the recent study, 41% of permanent molars in Lithuanian 5–6 years old children were affected by dental caries [8]. A repeated cross-sectional study demonstrated that the prevalence of dental caries increased from 85,4% in 2000 to 88,4% in 2010 among 4-6-year-old children in Kaunas, Lithuania [9]. These rates significantly increase with age and the prevalence of dental caries is higher in boys than in girls. In 2016, the overall prevalence of dental caries among 18-year-old Lithuanian adolescents was 78,3% [10].

In comparison to other Baltic states, in Estonia the mean caries experience of dentine caries lesions in permanent dentition was 0,8 (D 4-6 MFT) and 1,6 (D 4-6 MFS) among the first graders and 1,1 (D 4-6 MFT) and 1,6 (D 4-6 MFS) among the second graders, and 36,2%-48,3% of children aged between 7-8 years old have experienced dental caries [11]. In Latvia, the prevalence of dental caries in 12-year-old children was 98,5% for D1 MFT, 79.7% for D3 MFT, and 71,9% for D5 MFT [12],

while in Lithuania the prevalence of dental caries in children aged 12–15 years was 85,5% –92,9% [13]. It has been observed that prevalence and intensity of tooth decay has decreased. According to the researchers, these changes may have been related to the improvement of oral hygiene and the use of fluoride toothpaste. There are many different commercially available toothpastes these days, including non-fluoride toothpastes. Since all other dental caries etiological factors are constant, fluoride-containing toothpaste has been shown to be the best preventive measure for dental caries. It reduces the prevalence of dental caries by 22% [14, 15].

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9 According to these guidelines (Table 1.), for children 0-6 years old recommended fluoride concentration is 500-1000 ppm F-, depending on the risk of dental caries, and for the individuals over

6 years of age fluoride concentrations of 1000-1450 ppm F- are recommended.

Table 1. Guidelines on the use of fluoride toothpaste for Lithuanian children and adults (Coordination Commission for the Preventive Programs of the Chamber of Dentists of the Republic of Lithuania) [16].

Age (years) Low risk of

caries, ppm F

-High risk of

caries, ppm F- Frequency Size

0-2 years 500 1000 Twice daily Grain of rice

3-6 years 500 1000 Twice daily Pea

Over 6 years 1000 1450 Twice daily Up to full length of

brush (1-2 cm)

In Latvia, around half of 12 years old children brush their teeth twice a day, and only 21% of them know the concentration of fluoride in their toothpastes [17, 18]. According to another study conducted in Latvian population, 61% of new mothers thought that fluoride toothpaste could be harmful to their children [19].

There are no previous studies on prevalence of fluoride toothpaste use in families of schoolchildren in Kaunas County, Lithuania. It is not known how often parents choose non-fluoride toothpaste or toothpaste with a low fluoride concentration for their children. Accordingly, the aim of this research is to determine the prevalence of the use of fluoride toothpaste in families of Kaunas County, and to establish the association how the choice of toothpaste is related to different age groups, and to analyse the differences of toothpastes’ choice in relation to the place of residence.

Hypothesis:

Non-fluoride toothpaste is used in families of schoolchildren in Kaunas County.

Aim:

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Objectives:

1) To determine the prevalence of fluoride and non-fluoride toothpaste use among children and adults.

2) To analyse the differences in the prevalence of fluoride and non-fluoride toothpaste use among children and adults.

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REVIEW OF LITERATURE

Fluoride compounds demonstrate an anti-caries effect by promoting remineralisation of early caries lesions, strengthening tooth enamel through reduction of its solubility in acidic environment created by oral bacteria [20]. Fluorides are delivered topically through professional and self-applied methods. Systemically it is delivered through water, salt, milk fluoridation and fluoride tablets, drops or lozenges. Toothpastes remain the most conventional and effective topical method for self-application of fluoride to prevent dental caries.

1.1. Evolution of Toothpaste

Toothpastes have been used to eliminate objectionable oral odours, reducing toothache, strengthening the teeth, for aesthetics and as a prophylactic-therapeutic measure [21].

In around 1500 B.C.E written Egyptian medical manual, the Ebers Papyrus describes a recipe for tooth-cleaning preparations [22]. Ancient Egyptians were the first to develop oral hygiene products such as dental creams constituted of powdered eggshells, myrrh, pumice and ashes from oxen hooves [24]. The Chinese described a tooth-cleaning powder made of salt, musk and ammonia, and it was used in prevention of dental caries progress and teeth whitening [22]. Later Chinese began to flavour their toothpastes with ginseng, herbal mints and salt. Around 1000 BC, Persians used composition of burnt snail shells and oysters mixed with gypsum, honey, and herbs [23].

In tooth-cleaning preparations, Ancient Greeks and Romans propagated more abrasives such as grinded oyster shells and bones. Hippocrates (460-377 B.C.E.) in his text De Morbis Mulierum describes “Indian medicament” used for teeth cleaning and oral odor improvement. Hippocrates recommended to produce the dentifrice by generating a mixture after burning heads and other body parts of rodents [22]. The Romans cleaned and rubbed their teeth with wool and a dentifrice made of burnt heads of rodents, wolves, along with heels and feet of oxen and goats. Crushed snail shells, eggshells and pumice powder were used as an abrasive material and they were mixed with myrrh and salt [22]. Pliny (23-79 C.E.) advised to use ashes of hare’s head, spikenard and carbonate of lime in a dentifrice. In 47, Scribonius Largus described a toothpaste made from barley flour, vinegar, honey and sun-dried radish [22].

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12 In 17th century England, popular toothpowders made of powdered coral, pumice, crab shells, cuttle bone and ground china, were applied with a cloth. Charles Allen published a recipe for a toothpaste consisting of precipitate of pearls, powder of coral, red rose water. In 1807, a London firm of chemists recommended the use of charcoal as a dentifrice [24]. These early toothpastes consisted of tooth-damaging abrasives and did not contain effective remineralising systems.

After appearance of W. D. Miller’s theory of tooth decay in 1890, that stated that dental caries is caused by decalcification of the enamel due to organic acids generated by oral bacteria as the result of carbohydrates fermentation, the toothpaste industry began to incorporate alkaline base compounds to the formulation. The urea and dibasic ammonium phosphate were the first active ingredients in the composition of toothpaste, later toothpastes with chlorophyll also appeared. In 1873, toothpaste was first mass-produced in a jar by then Colgate & Co. Prior to 1892, toothpastes were produced in jars, until Dr. Washington Sheffield of Connecticut suggested to put toothpaste into a tube. In 1914 first fluoride-containing toothpastes appeared. In 1955, Crest toothpaste was likely to be first mass-marketed fluoride toothpaste worldwide. In 1960, the ADA approved the use of fluoride in toothpastes [22].

Nowadays, the most common delivery form of toothpaste is the single-phase tube. Due to higher formulations and production costs, toothpastes in pumps are not preferred by the manufacturers. Easier dispensing of the toothpaste is achieved by delivering in stand-up tubes, but such delivery format requires lower viscosity of paste. Gel-to-foam delivering format is also available [23].

The formulations of toothpastes were gradually improved for better fluoride bioavailability and lower abrasivity, better stain removal and breath freshening. Modern commercial toothpaste formulations contain therapeutic ingredients demonstrating activity against dental caries, gingivitis, calculus, dentine hypersensitivity, halitosis, and dental stains.

1.2. Fluoride in Toothpastes

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1.2.1. Pharmacokinetics of Fluoride and Fluoride Remineralisation

Fluoride is the main active ingredient in toothpastes acting efficiently in reducing dental caries worldwide. The successful application of fluoride depends on the retention and proximity to the site of action [27-29]. The maintaining of elevated fluoride ion concentration in contact to the dental hard tissues has long been believed to be as an important factor in caries control [30]. After topical application in oral environment, fluoride primarily contacts with the saliva.

Dental caries develops when demineralisation is more active than the remineralisation. In cases of remineralisation of previously demineralised dental hard tissues, the newly formed mineral structures are less soluble once fluoride ions are incorporated. Fluoride needs to be delivered to the oral cavity and be retained at target sites for as long as possible. Fluoride ions (F-) demonstrated an ability to

inhibit demineralisation and to promote remineralisation of hard dental structures even at very low concentrations [31, 32]. Salivary clearance of fluoride occurs over several hours after the application of topical fluoride. Studies have shown that 30–60 min after sodium fluoride (NaF) solution application salivary F- concentration tended to fall rapidly to below 1 ppm F- [33]. Similar salivary

clearance of fluoride was noticed after using fluoride toothpaste, fluoride varnish, fluoride tablets and fluoride-containing chewing gum [34]. Salivary fluoride concentration increases with increasing fluoride concentration in topical fluoride product [35, 36]. Studies reported that lower saliva fluoride concentrations were associated with higher saliva flow rates, therefore the rapidness of clearance phase is determined by salivary flow rate [37, 38].

1.2.2. Fluoride Reservoirs in Oral Cavity

The intra-oral structures that act as a reservoir to contain fluoride are enamel, dentine, dental plaque, systemic saliva and soft oral tissues of the gums, tongue, and oral mucosa [39-41]. In the oral cavity there are stagnation zones such as the buccal sulcus and interproximal areas. In these locations fluoride concentration maintain higher until the salivary flow diffuses it during the initial phase of salivary fluoride clearance. Due to high surface area, soft tissues demonstrate a great capacity to contain fluoride for the second phase of salivary fluoride clearance [42].

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14 Fluoride in saliva and in plaque fluid are correlated, irrespectively to tooth location [39, 51]. A study by Yao K et al. based on samples collected from few individuals, demonstrated that the oral soft tissues are important source of saliva fluoride [52]. Fluoride clearance was more rapid in intra-oral regions with higher salivary flow. Higher fluoride concentrations were detected in the upper vestibule of the mouth in comparison to the lower vestibule [52].

Even though soft tissues of oral cavity are most likely to be the reservoir for fluoride, the fluoride interaction with soft tissues requires more studies to generate a theoretical model that could describe fluoride transferring from oral soft tissues to the hard dental structures. Due to high detected concentrations of fluoride in salivary biofilms at certain mucosal sites, mucosa’s capacity to be the source of fluoride for the plaque requires further investigations.

1.3. Non-fluoride Remineralisation Systems in Toothpastes

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15 Some toothpastes contain unstabilised amorphous calcium phosphate (ACP), which intraorally is delivered in a product with a very low water activity or via dual-chamber device [53, 70]. Salts in ACP formulation dissolve after the contact with oral fluids, releasing free calcium and phosphate ions. The ions mingle together and result in the precipitation of ACP. If fluoride ions are present, amorphous calcium fluoride phosphate (ACFP) is generated. ACP and ACFP are not stable, therefore they later transform into hydroxyapatite and fluorhydroxyapatite [53]. ACFP-forming toothpaste showed ability to reduce root caries increment and in combination with fluoride it demonstrated high efficacy in lowering coronal caries [71]. However, there is a risk of inducing dental calculus formation due to long-term use of amorphous calcium phosphate.

Tricalcium phosphate (Ca3(PO4)2) is a biodegradable bioceramic material that is used in

remineralisation systems of the toothpastes, usually in form of functionalised beta-tricalcium phosphate (β-TCP) [72-74]. After the combination with surfactants and carboxylic acids, β-TCP is transformed into functionalised TCP (fTCP) [75], which, as a remineralisation system, contains low doses of calcium phosphate and is incorporated in toothpastes and other topical dental products [72, 76]. Since the remineralisation is mostly driven by phosphate and calcium ions in saliva, fTCP improves the action of fluoride on hard dental surfaces by preventing premature TCP-fluoride interactions and providing targeted delivery of TCP [75]. Caries-preventive effect of fTCP-containing toothpastes has been well demonstrated in various studies [75;77-81]. fTCP showed its ability to significantly remineralise defected enamel structure [79]. According to the studies, fTCP combined with fluoride improves remineralisation and generates more acid resistant mineral in enamel lesions and eroded enamel [73; 82-85].

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16 Nano-hydroxyapatite (nHAP) was approved as an anti-caries agent based on studies [91]. It also demonstrated the remineralising effect on caries lesions [92-94], and the enhanced activity of nHAP and fluoride in mutual combination [93]. Studies report that 10% nHAP could be the optimal concentration to remineralise early enamel lesions while used daily [94]. Nanohydroxyapatite closes micropores on demineralized dental surfaces [95]. After penetration to porous enamel structure, it attracts high numbers of phosphate and calcium ions to the defected enamel tissue [96]. As the result, nanohydroxyapatite promotes crystal integrity and growth [97, 98]. Even though nanohydroxyapatite-containing desensitizing agents demonstrated promising results in controlling tooth sensitivity [99-102], some clinical trials demonstrated similar results between nanohydroxyapatite and other desensitising agents [103-105]. However, based on the results of the meta-analysis, nHAP-containing treatment demonstrated higher efficacy than treatments without nHAP and placebo in relieving tooth sensitivity [106].

Another remineralising compound is arginine bicarbonate, that neutralises glycolytic acid, inhibits demineralisation and enriches alkali-generating Streptococcus sanguinis which prevents the overgrowth of Porphyromonas gingivalis in multi-species biofilms [107-111]. A randomized controlled study by Yiyuan Xue et al., demonstrated that 8% arginine-containing toothpaste can significantly reduce the lactic acid production from the in situ plaques [112]. After the dissolution of calcium carbonate, the released calcium remineralises mineral structure of hard dental tissues and the released carbonate can increase local rise of pH [113]. The increased pH values also appear in saliva and dental plaque due to fermentation of arginine [114, 115]. Thus, toothpastes containing arginine bicarbonate can be used for treating dental hypersensitivity by occlusion of exposed dentinal tubules and for controlling dental caries by increasing local pH values [116-118].

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17 The lacking clinical evidence on the efficacy and pharmacokinetics of non-fluoride remineralisation systems and a large amount of reliable and longitudinal clinical evidence supporting the anti-caries action of fluoride determines that fluoride remineralisation systems are the first choice for seeking caries-preventive and therapeutic effect.

1.4. Recommended Fluoride Concentrations in Toothpastes

The use of fluoride toothpaste is an efficient caries-preventive non-professional intervention and a non-restorative caries treatment [124-126]. The anti-caries effect was statistically significant when the fluoride concentration in toothpastes was 1000 ppm F- and higher [127]. The estimated efficacy

of fluoride toothpaste in caries prevention is 24% [15, 128].

In 1997, the European Academy of Paediatric Dentistry (EAPD) organised a workshop in Athens to generate guidelines for future use of fluorides among children in Europe. The first guidelines were published in 1998, the revised version appeared a year later [127]. In the recent EAPD Guidelines on the use of fluoride for caries prevention in children (Table 2.), the recommended fluoride concentrations in toothpastes are 1000 ppm F- and higher [127].

Although high levels of fluoride intake via fluoride supplements increase the risk of fluorosis in children [129], the ingestion of high fluoride concentration toothpaste may also negatively affect the development of teeth by causing dental fluorosis [130, 131]. Therefore, the guidelines for the use of fluoride toothpaste in different age groups need to be based on reliable scientific studies and the quality of evidence need to be assessed by evaluation systems such as GRADE [132].

Table 2. Recommended use of fluoride toothpastes in children (EAPD Guidelines on the use of fluoride for caries prevention in children) [149]

Age (years) Concentration

(ppm F-) Frequency Amount (g) Size

First tooth-up to

2 years 1000 Twice daily 0.125 Grain of rice

2-6 years 1000* Twice daily 0.25 Pea

Over 6 years 1450 Twice daily 0.5-1.0 Up to full

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18 Fluoride toothpastes containing lower concentrations could be used for children when the risk fluorosis is high, but the risk of dental caries is low [131]. When small children are exposed to various other sources of fluoride, toothpastes with less than 1000 ppm F- could be recommended [127]. On

the other hand, the evidence for the caries-preventive efficacy of the low fluoride concentration toothpastes is limited [133]. In various clinical trials fluoride toothpaste with 2800 ppm F

-concentration showed additional anti-caries effect seeking around 15% [134-136]. Although the evidence for the better efficacy of high fluoride toothpastes is lacking [137], toothpastes with high fluoride concentrations (up to 5000 ppm F-) could be prescribed for patients with special needs and

at very high risk of caries, or for those undertaking orthodontic treatment with fixed orthodontic appliances [127].

Studies also demonstrated that the efficiency of fluoride toothpaste was not affected by water fluoridation and it increased with higher baseline levels of D(M)FS, higher fluoride concentration and supervised brushing [15]. Other studies demonstrated that the clinical efficacy of a 500 ppm F-

fluoride toothpaste was similar to a 1100 ppm F- toothpaste when used by caries-inactive children,

but when the low-fluoride toothpaste was used by caries active children it seemed less effective than the 1100 ppm F- formulation [138]. A meta-analysis with 7 included clinical trials, which compared

when fluoride-containing toothpastes are used along oral health education against no intervention, assessed that when 1000-1500 ppm F- toothpastes were used, significant dental caries reduction in

primary dentition of preschool children at surfaces level was noticed in comparison to placebo or no intervention [139]. Previously performed clinical trial with caries active teenagers (9-12 years) demonstrated that there is no difference between a 500 ppm F- and 1100 ppm F- toothpaste [134].

Another 8-months experiment demonstrated 5000 ppm F- toothpaste to be more efficient measure to

control root caries in homebound 75+ years old than a 1450 ppm F- toothpaste [140], while a 3-month

experiment demonstrated that 5000 ppm F- toothpastes were significantly more effective than 1100

ppm F- toothpastes at remineralising primary root caries[141]. Thus, toothpaste with higher fluoride

concentrations should be used by the elderly people.

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MATERIAL AND METHODS

The research protocol was approved by the Bioethics Center of Lithuanian University of Health Sciences (LSMU) (Reference no. BEC-OF-19) (Annex No. 1). The research was conducted in accordance with the Declaration of Helsinki (World Medical Association 2013) and regulations on the protection of personal data (“EUR-Lex - 32016R0679 - EN - EUR-Lex” n.d.). The completed questionnaires were considered as a consent of study subjects.

2.1. Research design and research conditions

This cross-sectional questionnaire study used national data in one of the counties in Lithuania to investigate the use of fluoride and non-fluoride toothpaste in families of schoolchildren. A cross-sectional study was conducted from December 2020 to March 2021 in Kaunas County, Lithuania. Letters with invitations were sent to the principals of selected schools, explaining the aims of the research and how it will be carried out. The consents of principals representing 9 schools were obtained. The school principals were able to join and to refuse to participate in the research voluntarily.

After receiving signed consent forms from the school authorities, the link to the SurveyLegend questionnaire was sent together with the consent form for the study subjects to the school authorities. The school authorities shared the link to SurveyLegend questionnaire to the parents/guardians and invited them to participate in the survey on a voluntary basis by answering the questions anonymously. The parents/guardians were given the opportunity to join and to refuse to participate in the research voluntarily. The parents/guardians were able to stop the participation in the research at any point. The collected data in the survey was anonymous and will be saved for 1 year after the end of the research. After this period, collected and analysed data will be deleted.

2.2. Study population

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2.3. Research instrument

SurveyLegend questionnaire (Annex No. 2) for anonymous self-completion by parents was used to gain insight on sociodemographic (age of study subjects, number of family members, places of residence) and dental-related (used toothpastes) data. The questionnaire consisted of 3 questions concerning sociodemographic data, and 10 questions on the use of toothpaste. To answer the dental-related questions, study subjects had to upload the pictures of their used toothpastes. The questionnaire was tested on 25 volunteer parents/caretakers prior the main survey.

2.4. Data collection and data processing

The principals of 9 schools agreed to participate in the study (Annex No. 3). Due to very low response rate (15,05%), the answered questionnaires from 4 schools were not included in further data processing. The data was obtained from the questionnaires of 5 schools, where 1548 parents/guardians were invited to participate in the survey. 233 parents/guardians agreed to participate in the study by completing the questionnaires, while the remaining 1315 parents/guardians (84,95%), who did not fill the questionnaire, were regarded as the ones who refused to participate in the research. 13 (5,58%) questionnaires out of 233 completed questionnaires were excluded from the study due to incorrect answers or partial completion. Data from correctly 220 completed questionnaires were used for further data processing. Incorrectly answered or incomplete SurveyLegend questionnaires (n=13) were excluded from further data processing. Data from included in the study SurveyLegend questionnaires was extracted to the 1st Microsoft Office Excel Form. Then data on toothpaste use in

1st Microsoft Office Excel Form was entered into Google Form for each family member. The respondents were coded with two codes. The first code represented the school, and the second code represented the study subject. A combination of both codes formed a code that represented the family of study subject. The collected data in the Google Form was checked. If there were any discrepancies, data was compared with the answers obtained in primary questionnaires. Data from Google Form was extracted as 2nd Microsoft Office Excel Form that was used for statistical analysis.

2.5. Statistical analysis

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RESEARCH RESULTS

3.1. Descriptive statistics of study subjects: age and place of residence

In this study participated 877 study subjects (adults and children) from 220 families that declared their place of residence in Kaunas city (n=160; 72,73%), towns in Kaunas County (n=22; 10,00%), and rural areas in Kaunas County (n=38; 17,27%).

The quantity and distribution of study subjects in different age groups is presented in Table 3. In total, there were 384 children. 318 (82,81%) children were from urban areas, including Kaunas city (n=280; 72,92%) and towns in Kaunas County (n=38; 9,90%), while rural areas in Kaunas County were represented by 66 (17,19%) children. In this study, data concerning 493 adults was used. 403 (81,74%) adults lived in urban areas, including Kaunas city (n=350; 70,99%) and towns of Kaunas County (n=53; 10,75%), while 90 adults lived in rural areas (18,26%).

Table 3. The quantity and distribution of study subjects in different age groups (Total N=877)

Age group (city and towns) N Urban areas Rural areas (villages) N Total N (%)

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Fig. 1. Percentage distribution of study subjects belonging to various age groups

The study subjects of various age groups were distributed unevenly (Fig. 1.). In the chart, the vertically plotted bars depict that many study subjects belonged to the 34-44 age group (28,91%). In the adults’ groups, the lowest percentage (1,12%) of study subjects belonged to the 75+ age group. In the children’s groups, most respondents (21,09%) belonged to the 13-17 age group, while the lowest percentage (1,23%) of study subjects made the 0-2 age group.

The pie chart (Fig. 2.) represents the percentage distribution of study subjects living in different places of residence, and it indicates that most respondents were from Kaunas city (72,63%). The lowest percentage of respondents lived in towns of Kaunas county (10,16%).

Fig. 2. Percentage distribution of study subjects living in different places of residence

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3.2. Prevalence of fluoride and non-fluoride toothpaste use by age group and rural/urban classification

In 139 (63,18%) families, adults and children used the same toothpaste. In total, among the study subjects 105 different kinds of toothpastes were used (Annex No. 4). The toothpastes were produced by 62 different manufacturers. 27 (25,71%) different kinds of toothpastes were used among families in Kaunas county were non-fluoride, and 54 (51,43%) contained fluoride concentrations of 1000 ppm F- and higher.

In 3,18% (n=7) of families toothpastes containing 500-1000 ppm F- were used by 0-2 years old

children. In 5% (n=11) of families toothpastes containing 1000-1450 ppm F- were used by 3-5 years

old children, and in 77,73% (n=171) of families toothpastes containing 1000-1450 ppm F- were used

by adults and children over 6 years old.

The most prevalent fluoride concentration in toothpastes used by 0-5 old children was 500 ppm F-,

while among the children older than 5 years old and adults the most prevalent fluoride concentration was 1450 ppm F- (Table 4.).

Table 4. The most prevalent fluoride concentration in toothpastes used by various age groups

Age group Most prevalent fluoride

concentration (ppm F-) Users in age group N (%*)

Children 0-2 500 5 (45,45) 3-5 500 9 (36,00) 6-12 1450 70 (42,94) 13-17 1450 93 (50,27) Adults 18-24 1450 30 (60,00) 25-34 1450 16 (55,17) 35-44 1450 112 (44,27) 45-54 1450 61 (53,04) 55-64 1450 7 (33,33) 65-74 1450 6 (40,00) 75+ 1450 3 (30,00)

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Table 5. Users of non-fluoride toothpaste in various age groups

Age group Users in age group N (%*)

Children 0-2 2 (18,18) 3-5 3 (12,00) 6-12 20 (12,27) 13-17 30 (16,21) Adults 18-24 3 (6,00) 25-34 5 (17,24) 35-44 37 (14,62) 45-54 15 (12,10) 55-64 3 (14,28) 65-74 3 (20,00) 75+ 3 (30,00)

*The percentage value was computed by dividing the number of users in the age group by total number of study subjects in that age group.

The highest number of study subjects using non-fluoride toothpaste (0 ppm F-) lived in Kaunas city

(n=94), while the number of people who used non-fluoride toothpaste in villages (n=12) and towns of Kaunas County (n=11) were distributed similarly.

615 (70,13%) study subjects used fluoride toothpaste with more than 1000 ppm F-. 14 (38,89%)

children up to 5 years old used toothpaste containing more than 1000 ppm F-. Most study subjects

(n=592; 67,50%) choose 1000-1450 ppm F- toothpastes, and most of these subjects belong to the

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Fig. 3. Percentage distribution of non-fluoride and fluoride toothpaste users by different age groups

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Fig. 4. Percentage distribution of non-fluoride and fluoride toothpaste users living in different places of residence

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Fig. 5. Percentage distribution of non-fluoride toothpaste chosen by study subjects of various age groups living in different places of residence

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DISCUSSION

This cross-sectional study used data collected in one of the counties in Lithuania to investigate the use of fluoride and non-fluoride toothpaste in families of schoolchildren. It is the first study conducted in Lithuania that examines the prevalence of fluoride and non-fluoride toothpaste use by children and adults of different age groups living in different places of residence.

Over the last few decades, the prevalence of dental caries decreased worldwide, and most experts link it to the use of fluoride toothpaste [15, 145, 146]. The use of fluoride toothpaste is a long-recommended and efficient strategy to prevent dental caries [127]. Therefore, the children and adults in Kaunas County who use non-fluoride toothpaste are at higher risk dental caries and its potential complications such as pulpitis and abscesses. According to the results of our study, in Kaunas County 13,68% of study subjects used non-fluoride toothpaste, including 64 (12,98%) adults and 56 (14,58%) children, and in 139 (63,18%) families, adults and children used the same toothpaste.

The non-fluoride toothpaste users in present study were accounted more than twice higher than in similar study performed in Japan, where 5,1% of all toothpaste users chose non-fluoride toothpaste [147]. In another recent cross-sectional study by Matthew Hobbs et al. [148], in New Zealand 6,8% of adults and 6,4% of children used non-fluoride toothpaste, and it is twice less than in the present study.

On the other hand, the most popular choice of fluoride concentration in toothpaste corresponded the guidelines on the use of fluoride toothpaste for Lithuanian children and adults (Coordination Commission for the Preventive Programs of the Chamber of Dentists of the Republic of Lithuania) [16]. Most study subjects used 1000-1450 ppm F- toothpastes, and according to the recent studies that

compared non-fluoride toothpaste to fluoride toothpaste and confirmed that using 1000–1250 ppm F

-or 1450–1500 ppm F- toothpaste provides a clinically important benefit to prevent dental caries [149].

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ACKNOWLEDGEMENT

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CONFLICT OF INTERESTS

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CONCLUSIONS

1) The children used toothpastes with less fluoride concentration than the adults. The use of non-fluoride toothpaste is more prevalent in children than in adults.

2) The children of parents who used non-fluoride toothpaste also tended to use non-fluoride toothpaste.

3) The toothpastes with a higher concentration of fluoride were selected for toothbrushing accordingly with the increasing age of the individual.

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PRACTICAL RECOMMENDATIONS

Further studies on the use of fluoride toothpaste in Lithuania should be conducted at the state level, including all administrative regions and larger sample size. Studies on the use of fluoride toothpaste should be carried out more frequently. Future research projects, in addition to information about fluoride concentration in toothpastes, should include data about non-fluoride remineralising systems in toothpastes, toothbrushing frequency, spitting and rinsing after toothbrushing, supervised brushing, self-assessment of oral health and the factors determining fluoride/non-fluoride toothpaste use. The knowledge of dentists and dental hygienists about effective fluoride concentrations in toothpastes should be assessed. The clinically applied recommendations on the use fluoride toothpaste by dentists and dental hygienists should be identified.

Data concerning fluoride concentration in toothpastes used by children could be collected during annual dental prophylaxis appointments, thus the corelation of dental caries prevalence and the prevalence of non-fluoride or low-fluoride toothpaste use could be established.

The national guidelines for the use of fluoride toothpaste in Lithuania should be reviewed and renewed based on GRADE or other framework, providing a systematic approach for making evidence-based clinical practice recommendations, or already existing reliable guidelines for the use of fluoride, e. g., Guidelines for the Use of Fluoride (2019) by EAPD (European Archives of Paediatric Dentistry), could be applied.

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