Efficacy of a Novel Fluoride Varnish in Preventing WSL During/After Treatment With Fixed Orthodontic Appliances

NCT03725020 | Unknown

• 1 other identifier: MalmoUSonesson
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of the present study is to evaluate the efficacy of a novel fluoride varnish (NFV) in preventing white spot lesion development in adolescents during and after treatment with fixed orthodontic appliances.

Conditions

Orthodontic Appliance Complication

Keywords

Orthodontics; Fixed appliance; White Spot Lesions; Fluoride varnish

Outcome Measures

Primary Outcomes (1)

• The primary outcome will be incidence of white spot lesions on the labial surfaces of the maxillary incisors, canines and premolars

  Assessed from high-resolution digital photos

  12-24 months

Secondary Outcomes (1)

• The secondary outcome is the prevalence of WSLs at debonding and one year after debond

  12 months

Study Arms (2)

Fluoride varnish

EXPERIMENTAL

During the course of the orthodontic treatment, the patients are regularly checked every 6th week. At the end of each such occasion, the clinical staff will apply the test varnish with a small brush in a thin layer around the base of the braces on the maxillary teeth. The varnish is let to dry and the subjects are instructed not to eat or drink within 60 minutes after the application. The NFV test varnish has mint flavour and the active ingredient is ammonium fluoride dissolved in ethanol, water and an acrylate polymer.

Other: Fluoride varnish

Varnish without Fluoride

PLACEBO COMPARATOR

During the course of the orthodontic treatment, the patients are regularly checked every 6th week. At the end of each such occasion, the clinical staff will apply either the placebo varnish with a small brush in a thin layer around the base of the braces on the maxillary teeth. The varnish is let to dry and the subjects are instructed not to eat or drink within 60 minutes after the application. The placebo varnish has an identical composition as the test varnish except for the ammonium fluoride. Thus, taste, colour and handling properties are the same.

Other: Fluoride varnish

Interventions

Fluoride varnish OTHER

The study will employ a double-blind, randomized placebo-controlled design with two parallel groups. The intervention will start at onset of the fixed appliances and will be finalized one year after debond. The primary outcome will be incidence of white spot lesions on the labial surfaces of the maxillary incisors, canines and premolars, as assessed from high-resolution digital photos. The secondary outcome is the prevalence of WSLs at debonding.

Fluoride varnish; Varnish without Fluoride

Eligibility Criteria

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

You may not qualify if:

• In the event of long-term prescriptions of general antibiotics during the course of the study, this should be recorded separately

Sponsors & Collaborators

• Malmö University: lead
• University of Copenhagen: collaborator

Related Publications (2)

• Sonesson M, Brechter A, Lindman R, Abdulraheem S, Twetman S. Fluoride varnish for white spot lesion prevention during orthodontic treatment: results of a randomized controlled trial 1 year after debonding. Eur J Orthod. 2021 Aug 3;43(4):473-477. doi: 10.1093/ejo/cjaa055.

  PMID: 33009565 DERIVED

• Sonesson M, Brechter A, Abdulraheem S, Lindman R, Twetman S. Fluoride varnish for the prevention of white spot lesions during orthodontic treatment with fixed appliances: a randomized controlled trial. Eur J Orthod. 2020 Jun 23;42(3):326-330. doi: 10.1093/ejo/cjz045.

  PMID: 31197364 DERIVED

Study Officials

• Mikael Sonesson, Odont. Dr.

  Malmö University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: October 29, 2018
• First Posted: October 30, 2018
• Study Start: June 1, 2014
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2019
• Last Updated: November 6, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share