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

Overview

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.

Full Title of Study: “Efficacy of a Novel Fluoride Varnish Formula in Preventing White Spot Lesions During and After Treatment With Fixed Orthodontic Appliances”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 31, 2018

Detailed Description

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 debonding. 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. 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 test or the placebo varnish with a small brush in a thin layer around the base of the braces on the maxillary teeth. The pre- and post-treatment photos are projected on a screen (Hewlett Packard ProBook 6650b, Palo Alto CA, USA) in a dark room and the incidence and severity of enamel demineralization will be registered independently by two experienced and calibrated orthodontists according to the index of Gorelick et al. (1982).

Interventions

  • Other: Fluoride varnish
    • 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.

Arms, Groups and Cohorts

  • Experimental: Fluoride varnish
    • 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.
  • Placebo Comparator: Varnish without Fluoride
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • The primary outcome will be incidence of white spot lesions on the labial surfaces of the maxillary incisors, canines and premolars
    • Time Frame: 12-24 months
    • Assessed from high-resolution digital photos

Secondary Measures

  • The secondary outcome is the prevalence of WSLs at debonding and one year after debond
    • Time Frame: 12 months
    • Assessed from high-resolution digital photos

Participating in This Clinical Trial

Inclusion Criteria

  • The inclusion criterion is a scheduled treatment with fixed maxillary appliances according a standard straight-wire concept (McLaughlin et al., 2001) during a period of at least 12 months Exclusion Criteria:

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

Gender Eligibility: All

Minimum Age: 12 Years

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Malmö University
  • Collaborator
    • University of Copenhagen
  • Provider of Information About this Clinical Study
    • Principal Investigator: Mikael Sonesson, Lecturer – Malmö University
  • Overall Official(s)
    • Mikael Sonesson, Odont. Dr., Principal Investigator, Malmö University

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