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

NCT04560478 | Completed DMC FDA Device

• 1 other identifier: COD_Ortho2
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

White Spot Lesion

Keywords

Oral Hygiene; Orthodontics; White spot lesion; enamel decalcification

Outcome Measures

Primary Outcomes (1)

• Enamel Decalcification Index

  Extent and severity of white spot lesion formation

  12 months

Secondary Outcomes (4)

• Location of White Spot Lesions

  12 months

• Most Common Tooth for White Spot Formation

  12 Months

• Oral Hygiene Status

  12 Months

• Sex Differences

  12 Months

Study Arms (2)

Pro Seal Sealant

ACTIVE COMPARATOR

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

Device: Pro Seal Sealant

MI Varnish

ACTIVE COMPARATOR

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

Device: MI Varnish

Interventions

Pro Seal Sealant DEVICE

Sealant was reapplied every 3 months

Pro Seal Sealant

MI Varnish DEVICE

Fluoride varnish was applied every 4-6 weeks

MI Varnish

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Texas A&M University: lead

Study Sites (1)

Texas A&M University College of Dentistry

Dallas, Texas, 75246, United States

Location

Related 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. doi: 10.1093/ejo/16.1.19.

  PMID: 8181546 RESULT

• 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.

  PMID: 5264376 RESULT

Study Officials

• Peter Buschang, PhD

  Texas A&M University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: single center, parallel, randomized clinical trial

Study Record Dates

• First Submitted: September 17, 2020
• First Posted: September 23, 2020
• Study Start: October 1, 2018
• Primary Completion: February 10, 2020
• Study Completion: March 1, 2020
• Last Updated: September 23, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)