Clinical trial NCT03720379: Efficacy of Fluor Protector S in the Prevention in Adolescents
Official title: Efficacy of Fluor Protector S in the Prevention of Tooth Decay in Adolescents
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Caries
Fluor
Keywords: fluoride varnish
dental caries
ADOLESCENTS
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
Collaborators: name: Ivoclar Vivadent AG
name: Wroclaw Medical University
First posted: 2018-10-25
Enrollment: 168
Sex: ALL
Minimum age (years): 12
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We plan to include 168 subjects in this study.

1. Dental examination Qualified for the study will receive oral and written information on the causative factors of dental caries, hygienic and dietary recommendations.
2. Oral hygiene instruction will be provided.
3. Caries risk assesment
4. Application Fluor Protector S or Placebo

Dental examination will be performed before the intervention (preliminary), after 6 months and after 12 months. Dental exams will include an interview, a physical examination , radiological examination (bite- wing x-ray images) and Diagnodent assessment.

The applications of Fluor Protector S (intervention A) or placebo (intervention B) will be performed every three months during one year.
Primary purpose: PREVENTION

Brief summary: Purpose of the study is to evaluate the effectiveness of Fluor Protector S in preventing tooth decay in adolescents and to isolate factors that reduce its effectiveness.

In this study, half of the randomly assigned participants will received fluoride varnish (Fluor Protector S) and will be considered an intervention group. The other half will undergo placebo application.

Detailed description: Evidence from 6 systematic reviews involving 200 trials and more than 80,000 participants further supports the effectiveness of fluoride varnishes, applied professionally 2-4 times a year, for preventing dental caries. Additionally, the simultaneous use of fluoride varnishes with fluoride toothpaste appears to significantly enhance the caries-inhibiting effect compared with the use of fluoride toothpaste alone. The relative benefit of fluoride varnishes application seems to occur irrespective of baseline caries risk, baseline caries severity, background exposure to fluorides and application features such as prior prophylaxis, concentration of fluoride or frequency of application.

To determine the sample size, the results of epidemiological studies conducted in the framework of the health monitoring of the Polish population in 2015 in the group of people aged 15 years (dmf = 5.75) and in 2016 in the group of people aged 12 years (dmf = 3) 0.7 as annual growth of caries, and literature data on the effectiveness of fluoride varnish in the prevention of permanent tooth decay in the general population at 43% (a reduction of about 0.3% per year in dmf, Standard Deviation = 0.8) and was considered achievable in the case Apply Fluor Protector S at 3 months intervals in the high risk group of caries. Size of the study group with such assumptions (α = 0,05, power = 80%, mean reduction of dmf: 0,3, Standard Deviation = 0,8 ; t test for comparison of two groups) - Minimum 84 patients \[70 patients+ 20% (dropped out), in both groups\].

Participants will be allocated to the "test" and to the "control" group, respectively, by computer-generated randomly permuted blocks using R package in statistical software..

* The children will be examined and re-examined clinically by the same examiners.
* Statistical analyses will be performed using statistical software, the level of significance was set at 0.05. Intra-examiner reliability was assessed by kappa statistics.
* To compare average values between two independent groups U Mann-Whitney test will be used (for e.g. to compare experimental group with the control one); Wilcoxon signed-rank test will be used for paired samples (for e.g. to compare first measurement with final measurement for experimental group). Comparison of fractions will be conducted using Pearson's chi-square test of independence and Z test. The 95% confidence intervals will be calculated on the basis of normal approximation.

Purpose of the study is to evaluate the effectiveness of Fluor Protector S in preventing tooth decay in adolescents and to isolate factors that reduce its effectiveness.

Eligibility criteria: Inclusion Criteria:

* Age\> 12 ≤ 19 years
* All permanent teeth (except the third molar teeth)
* Restored caries lesions
* Teeth with International Caries Detection and Assessment System II score 0, 1, or 2
* Agreement of parents / legal guardians and patients to participate in the study

Exclusion Criteria:

* Planned change of residence during the year
* Chronic illness or medication that increases the risk of tooth decay
* Orthodontic treatment
* Caries lesions

Primary outcomes:
measure: Occurrence and intensity of dental caries
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Dorota Olczak-Kowalczyk
state: Warsaw, 18 Miodowa Saint
Study officials:
affiliation: Medical University of Warsaw
name: Dorota Olczak Kowalczyk, PROFESSOR
role: STUDY_DIRECTOR
References:
citation: Lenzi TL, Montagner AF, Soares FZ, de Oliveira Rocha R. Are topical fluorides effective for treating incipient carious lesions?: A systematic review and meta-analysis. J Am Dent Assoc. 2016 Feb;147(2):84-91.e1. doi: 10.1016/j.adaj.2015.06.018. Epub 2015 Nov 6.
citation: Bansal A, Ingle NA, Kaur N, Ingle E. Recent advancements in fluoride: A systematic review. J Int Soc Prev Community Dent. 2015 Sep-Oct;5(5):341-6. doi: 10.4103/2231-0762.165927.
citation: Weyant RJ, Tracy SL, Anselmo TT, Beltran-Aguilar ED, Donly KJ, Frese WA, Hujoel PP, Iafolla T, Kohn W, Kumar J, Levy SM, Tinanoff N, Wright JT, Zero D, Aravamudhan K, Frantsve-Hawley J, Meyer DM; American Dental Association Council on Scientific Affairs Expert Panel on Topical Fluoride Caries Preventive Agents. Topical fluoride for caries prevention: executive summary of the updated clinical recommendations and supporting systematic review. J Am Dent Assoc. 2013 Nov;144(11):1279-91. doi: 10.14219/jada.archive.2013.0057.
citation: Richards D. Substantial reduction in caries from regular fluoride varnish application. Evid Based Dent. 2013 Sep;14(3):72-3. doi: 10.1038/sj.ebd.6400947.
citation: Gao SS, Zhang S, Mei ML, Lo EC, Chu CH. Caries remineralisation and arresting effect in children by professionally applied fluoride treatment - a systematic review. BMC Oral Health. 2016 Feb 1;16:12. doi: 10.1186/s12903-016-0171-6.
citation: Marinho VC, Worthington HV, Walsh T, Clarkson JE. Fluoride varnishes for preventing dental caries in children and adolescents. Cochrane Database Syst Rev. 2013 Jul 11;2013(7):CD002279. doi: 10.1002/14651858.CD002279.pub2.