Efficacy of a Novel Fluoride Varnish in Preventing WSL During/After Treatment With Fixed Orthodontic Appliances
November 5, 2018 updated by: Mikael Sonesson, Malmö University
Efficacy of a Novel Fluoride Varnish Formula in Preventing White Spot Lesions During and After Treatment With Fixed Orthodontic Appliances
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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).
Study Type
Interventional
Enrollment (Actual)
180
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
12-24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Mikael Sonesson, Odont. Dr., Malmö University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2014
Primary Completion (Anticipated)
December 31, 2018
Study Completion (Anticipated)
December 31, 2019
Study Registration Dates
First Submitted
October 29, 2018
First Submitted That Met QC Criteria
October 29, 2018
First Posted (Actual)
October 30, 2018
Study Record Updates
Last Update Posted (Actual)
November 6, 2018
Last Update Submitted That Met QC Criteria
November 5, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MalmoUSonesson
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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