Clinical trial NCT04560478: Comparing Fluoride Varnish and Sealant to Prevent White Spots in Orthodontic Patients
Official title: THE EFFICACY OF MI VARNISH VERSUS PRO SEAL SEALANT ON PREVENTION OF WHITE SPOT LESIONS IN ORTHODONTIC PATIENTS: A RANDOMIZED CLINICAL TRIAL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: White Spot Lesion
Keywords: Oral Hygiene
Orthodontics
White spot lesion
enamel decalcification
Lead sponsor: Texas A&M University
Sponsor class: OTHER
First posted: 2020-09-23
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single center, parallel, randomized clinical trial
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Enamel Decalcification Index
timeFrame: 12 months
Secondary outcomes:
measure: Location of White Spot Lesions
timeFrame: 12 months
measure: Most Common Tooth for White Spot Formation
timeFrame: 12 Months
measure: Oral Hygiene Status
timeFrame: 12 Months
measure: Sex Differences
timeFrame: 12 Months
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Texas A&M University College of Dentistry
state: Texas
Study officials:
affiliation: Texas A&M University
name: Peter Buschang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Banks PA, Richmond S. Enamel sealants: a clinical evaluation of their value during fixed appliance therapy. Eur J Orthod. 1994 Feb;16(1):19-25. doi: 10.1093/ejo/16.1.19.
citation: Turesky S, Gilmore ND, Glickman I. Reduced plaque formation by the chloromethyl analogue of victamine C. J Periodontol. 1970 Jan;41(1):41-3. doi: 10.1902/jop.1970.41.41.41. No abstract available.