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

NCT ID: NCT04560478

Last Updated: 2020-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2020-03-01

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.

Conditions

White Spot Lesion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Pro Seal Sealant

ProSeal Sealant was applied to the facial surfaces of the maxillary anterior teeth (canine to canine)

Group Type: ACTIVE_COMPARATOR

Pro Seal Sealant

Intervention Type: DEVICE

Sealant was reapplied every 3 months

MI Varnish

MI Fluoride Varnish was applied to the maxillary anterior teeth (canine to canine)

Group Type: ACTIVE_COMPARATOR

MI Varnish

Intervention Type: DEVICE

Fluoride varnish was applied every 4-6 weeks

Interventions

Pro Seal Sealant

Sealant was reapplied every 3 months

Intervention Type: DEVICE

MI Varnish

Fluoride varnish was applied every 4-6 weeks

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Texas A&M University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Buschang, PhD

Role: PRINCIPAL_INVESTIGATOR

Texas A&M University

Locations

Texas A&M University College of Dentistry

Dallas, Texas, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 8181546 (View on PubMed)

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.

Reference Type: RESULT

PMID: 5264376 (View on PubMed)

Other Identifiers

COD_Ortho2

Identifier Type: -

Identifier Source: org_study_id