Comparing Fluoride Varnish and Sealant to Prevent White Spots in Orthodontic Patients

Study Overview
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Brief Summary
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The purpose of the study is o compare the efficacy of CPP-ACP MI Varnish and ProSeal sealant in preventing white spot lesion (WSL) formation in orthodontic patients.

Detailed Description
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This prospective randomized clinical trial included 40 orthodontic patients between the ages of 12-17 who were randomly allocated to two groups. Group 1 (Sealant Group) received sealant on the maxillary anterior canines, lateral incisors, and central incisors, with reapplication of the sealant every 3 months. Group 2 (Varnish Group) had MI Varnish applied every 4-6 weeks, without sealant placed on the maxillary anterior teeth. White spot lesion formation was evaluated with standardized digital photographs at two timepoints, T1 (initial appointment before bonding), and T2 (12 months later, with brackets removed). The brackets were removed in order to facilitate an adequate photographic exam. Photographs were analyzed side-by-side at the conclusion of the study with the Enamel Decalcification Index (EDI). The location of WSLs were recorded by tooth type and by region. Oral hygiene was evaluated at T1 and T2.

Official Title
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THE EFFICACY OF MI VARNISH VERSUS PRO SEAL SEALANT ON PREVENTION OF WHITE SPOT LESIONS IN ORTHODONTIC PATIENTS: A RANDOMIZED CLINICAL TRIAL

Conditions
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White Spot Lesion

Intervention / Treatment
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* Device: Pro Seal Sealant
* Device: MI Varnish


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: no significant medical history no underlying medical problems such as Sjogren's Syndrome or conditions requiring more than 2 medications (to prevent bias of possible dry mouth) less than 17 years old at the start of orthodontic treatment, fully erupted permanent maxillary canines and incisors, starting fixed orthodontic treatment ability to come to appointments every 4-6 weeks. Exclusion Criteria: professional fluoride application in the last 3 months allergy to milk untreated cavitated lesions heavy initial fluorosis dry mouth pregnancy any illness/condition that the investigators felt would affect the study outcome.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: single center, parallel, randomized clinical trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pro Seal Sealant<br>ProSeal Sealant was applied to the facial surfaces of the maxillary anterior teeth (canine to canine) | Device: Pro Seal Sealant<br>* Sealant was reapplied every 3 months<br>|
| Active Comparator: MI Varnish<br>MI Fluoride Varnish was applied to the maxillary anterior teeth (canine to canine) | Device: MI Varnish<br>* Fluoride varnish was applied every 4-6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enamel Decalcification Index | Extent and severity of white spot lesion formation | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Location of White Spot Lesions | Mesial, Distal, Incisal or Gingival Region | 12 months | 
| Most Common Tooth for White Spot Formation | Maxillary Canine, Lateral, or Central Incisor | 12 Months | 
| Oral Hygiene Status | Measurement of plaque accumulation on maxillary teeth | 12 Months | 
| Sex Differences | Male versus Female | 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral Hygiene, Orthodontics, White spot lesion, enamel decalcification