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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04560478
Other study ID # COD_Ortho2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2018
Est. completion date March 1, 2020

Study information

Verified date September 2020
Source Texas A&M University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date March 1, 2020
Est. primary completion date February 10, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years to 17 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Pro Seal Sealant
Sealant was reapplied every 3 months
MI Varnish
Fluoride varnish was applied every 4-6 weeks

Locations

Country Name City State
United States Texas A&M University College of Dentistry Dallas Texas

Sponsors (1)

Lead Sponsor Collaborator
Texas A&M University

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Enamel Decalcification Index Extent and severity of white spot lesion formation 12 months
Secondary Location of White Spot Lesions Mesial, Distal, Incisal or Gingival Region 12 months
Secondary Most Common Tooth for White Spot Formation Maxillary Canine, Lateral, or Central Incisor 12 Months
Secondary Oral Hygiene Status Measurement of plaque accumulation on maxillary teeth 12 Months
Secondary Sex Differences Male versus Female 12 Months
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