Efficacy of Fluor Protector S in the Prevention in Adolescents

Dental Caries Clinical Trial

Official title:

Efficacy of Fluor Protector S in the Prevention of Tooth Decay in Adolescents

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03720379
• Other study ID #: KB/226/2017
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 19, 2018
• Est. completion date: May 2020

Study information

• Verified date: October 2018
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 168
• Est. completion date: May 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries
• Fluor

Intervention

Device:
• Fluor Protector S
. All of the elements of a clinical trial and the varnish applications will be performed every three-month during one year: Changes in The Simplified Oral Hygiene Index (OHl-S), white spot carious lesion discovered at the initial assessment as invisible, visible and inactive, active, cavities), dmft and dmfs and their components, bite-wings and Diagnodent assessment will be scored at follow-up examinations.
• Placebo
All of the elements of a clinical trial and the placebo applications will be performed every three-month during one year: Changes in The Simplified Oral Hygiene Index (OHl-S), white spot carious lesion discovered at the initial assessment as invisible, visible and inactive, active, cavities), dmft and dmfs and their components, bite-wings and Diagnodent assessment will be scored at follow-up examinations.

Locations

Country	Name	City	State
Poland	Dorota Olczak-Kowalczyk	Warsaw	Warsaw, 18 Miodowa Saint

Sponsors (3)

Lead Sponsor	Collaborator
Medical University of Warsaw	Ivoclar Vivadent AG, Wroclaw Medical University

Country where clinical trial is conducted

Poland, 

References & Publications (6)

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. Review. — View 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. Review. — View 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. Review. — View 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;(7):CD002279. doi: 10.1002/14651858.CD002279.pub2. Review. — View 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. — View Citation

Weyant RJ, Tracy SL, Anselmo TT, Beltrán-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. Review. Erratum in: J Am Dent Assoc. 2013 Dec;144(12):1335. Dosage error in article text. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence and intensity of dental caries	The decrease of caries, which means a lower caries occurrence and intensity (lower caries index dmft/dmfs) when comparing to the placebo group.; Diagnodent assessment scale similar at baseline and at the end of the study. The same number of teeth/surfaces with no caries in the fluoride varnish group when comparing to the placebo group, according to scale: 0-14 No caries 15-20 Enamel caries 21-99 Dentinal caries; In the study, bite-wing images are planned at 12 months intervals. The scale will be used to evaluate: E1 - carious lesion including <1/2 enamel, E2 - carious lesion including> 1/2 enamel, D1 - tooth decay in dentin, not exceeding 1/3 of dentin, D2 - caries in the middle 1/3 of dentin, D3 carious lesion > 2/3 of dentin. Codes E1 and E2 will be recorded as pre-cavity, codes = D1 as cavity. Primary outcome is no signs of caries during radiological examination in fluoride varnish group when comparing to the placebo group.	12 months