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OpenTrials
Completed

NCT Number: NCT04560478

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

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.

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Key information

Conditions

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Texas A&M University College of Dentistry

Dallas, Texas, 75246, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pro Seal Sealant

Device

Sealant was reapplied every 3 months

MI Varnish

Device

Fluoride varnish was applied every 4-6 weeks

Primary outcomes

  1. Enamel Decalcification Index

    Time frame: 12 months

    Extent and severity of white spot lesion formation

Secondary outcomes

  1. Location of White Spot Lesions

    Time frame: 12 months

    Mesial, Distal, Incisal or Gingival Region

  2. Most Common Tooth for White Spot Formation

    Time frame: 12 Months

    Maxillary Canine, Lateral, or Central Incisor

  3. Oral Hygiene Status

    Time frame: 12 Months

    Measurement of plaque accumulation on maxillary teeth

  4. Sex Differences

    Time frame: 12 Months

    Male versus Female

Sponsors and collaborators

Lead sponsor

Texas A&M University

Other

Registry information

Official study title

THE EFFICACY OF MI VARNISH VERSUS PRO SEAL SEALANT ON PREVENTION OF WHITE SPOT LESIONS IN ORTHODONTIC PATIENTS: A RANDOMIZED CLINICAL TRIAL

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 23, 2020
Registry last updated
Sep 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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