search
Back to results

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

Primary Purpose

White Spot Lesion

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pro Seal Sealant
MI Varnish
Sponsored by
Texas A&M University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for White Spot Lesion focused on measuring Oral Hygiene, Orthodontics, White spot lesion, enamel decalcification

Eligibility Criteria

12 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Texas A&M University College of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Pro Seal Sealant

MI Varnish

Arm Description

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

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

Outcomes

Primary Outcome Measures

Enamel Decalcification Index
Extent and severity of white spot lesion formation

Secondary Outcome Measures

Location of White Spot Lesions
Mesial, Distal, Incisal or Gingival Region
Most Common Tooth for White Spot Formation
Maxillary Canine, Lateral, or Central Incisor
Oral Hygiene Status
Measurement of plaque accumulation on maxillary teeth
Sex Differences
Male versus Female

Full Information

First Posted
September 17, 2020
Last Updated
September 17, 2020
Sponsor
Texas A&M University
search

1. Study Identification

Unique Protocol Identification Number
NCT04560478
Brief Title
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

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
February 10, 2020 (Actual)
Study Completion Date
March 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Texas A&M University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
White Spot Lesion
Keywords
Oral Hygiene, Orthodontics, White spot lesion, enamel decalcification

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
single center, parallel, randomized clinical trial
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pro Seal Sealant
Arm Type
Active Comparator
Arm Description
ProSeal Sealant was applied to the facial surfaces of the maxillary anterior teeth (canine to canine)
Arm Title
MI Varnish
Arm Type
Active Comparator
Arm Description
MI Fluoride Varnish was applied to the maxillary anterior teeth (canine to canine)
Intervention Type
Device
Intervention Name(s)
Pro Seal Sealant
Intervention Description
Sealant was reapplied every 3 months
Intervention Type
Device
Intervention Name(s)
MI Varnish
Intervention Description
Fluoride varnish was applied every 4-6 weeks
Primary Outcome Measure Information:
Title
Enamel Decalcification Index
Description
Extent and severity of white spot lesion formation
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Location of White Spot Lesions
Description
Mesial, Distal, Incisal or Gingival Region
Time Frame
12 months
Title
Most Common Tooth for White Spot Formation
Description
Maxillary Canine, Lateral, or Central Incisor
Time Frame
12 Months
Title
Oral Hygiene Status
Description
Measurement of plaque accumulation on maxillary teeth
Time Frame
12 Months
Title
Sex Differences
Description
Male versus Female
Time Frame
12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Buschang, PhD
Organizational Affiliation
Texas A&M University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas A&M University College of Dentistry
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual results of the study will not be shared.
Citations:
PubMed Identifier
8181546
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.
Results Reference
result
PubMed Identifier
5264376
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs