NCT03720379|UnknownDMC
Loading search results
Sponsor study identifier
interventional
168
1 country
1
Study Start
October 19, 2018
Actual (reported)Primary Completion
January 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 17, 2018
Actual (reported)October 19, 2018
Actual (reported)October 25, 2018
Actual (reported)January 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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.
\- 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.
. 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.
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.
Dorota Olczak-Kowalczyk
Warsaw, Warsaw, 18 Miodowa Saint, 00-246, Poland
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.
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.
Dorota Olczak Kowalczyk, PROFESSOR
Medical University of Warsaw
Older Adult Effectiveness of 2 Treatments
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
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.
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.
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.
First Submitted
October 17, 2018
First Posted
October 25, 2018
Study Start
October 19, 2018
Actual (reported)Primary Completion
January 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 27, 2019
Record last verified: 2018-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: