Efficacy of Fluor Protector S in the Prevention in Adolescents

NCT03720379 | Unknown DMC

• 1 other identifier: KB/226/2017
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries; Fluor

Keywords

fluoride varnish; dental caries; ADOLESCENTS

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Fluoride Varnish - Fluor PROTECTOR S

ACTIVE COMPARATOR

Fluor Protector S - manufacturer: Ivoclar Vivadent Composition: ethanol, water, polymer, saccharin, mint flavor, 1.5% ammonium fluoride (7700 ppm fluoride), additional ingredients APPLICATION OF Fluor Protector S will be performed AT BASELINE, after 3,6 months (control 1) and after 9 and 12 months (control 2). Preliminary(AT BASELINE) and control dental exams after 12 months will include an interview and a physical examination, radiological and Diagnodent examination, a 6 months follow-up -a physical examination, Diagnodent examination and interview.

Device: Fluor Protector S

PLACEBO

PLACEBO COMPARATOR

\- Placebo - manufacturer: Ivoclar Vivadent Composition: ethanol, water, polymer, saccharin, mint flavor. APPLICATION OF PLACEBO will be performed AT BASELINE, after 3,6 months (control 1) and after 9 AND 12 months (control 2). Preliminary(AT BASELINE) and control dental exams after 12 months will include an interview and a physical examination, radiological and Diagnodent examination, a 6 months follow-up -a physical examination, Diagnodent examination and interview.

Device: Placebo

Interventions

Fluor Protector S DEVICE

. 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.

Fluoride Varnish - Fluor PROTECTOR S

Placebo DEVICE

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.

PLACEBO

Eligibility Criteria

• Age: 12 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Warsaw: lead
• Ivoclar Vivadent AG: collaborator
• Wroclaw Medical University: collaborator

Study Sites (1)

Dorota Olczak-Kowalczyk

Warsaw, Warsaw, 18 Miodowa Saint, 00-246, Poland

Location

Related Publications (6)

• 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.

  PMID: 26562737 BACKGROUND

• 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.

  PMID: 26539383 BACKGROUND

• 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.

  PMID: 24177407 BACKGROUND

• 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.

  PMID: 24071672 BACKGROUND

• 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.

  PMID: 26831727 BACKGROUND

• 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.

  PMID: 23846772 BACKGROUND

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Dorota Olczak Kowalczyk, PROFESSOR

  Medical University of Warsaw

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All participants,Care Providers, Investigators and Outcomes Assessor will be aware of the current subject's allocation and will be unconscious which product is fluoride varnish and which placebo. participants assigned to intervention(s) based on a protocol Patients will be distributed between Group A (Fluor Protector S) and group B (placebo) according to allocation for 2 types of intervention and blindness (codes for the type of intervention A and B will be assigned to patient numbers according to the reporting order and placed in opaque envelopes).
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 17, 2018
• First Posted: October 25, 2018
• Study Start: October 19, 2018
• Primary Completion: January 1, 2020
• Study Completion: May 1, 2020
• Last Updated: June 27, 2019

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)