The Prevalence of White Spot Lesions During Orthodontic Treatment With Fixed Appliances (WSLs)

Cross-Sectional Study: The Prevalence of White Spot Lesions During Orthodontic Treatment With Fixed Appliances

This study investigates how often cavities develop on the permanent teeth of patients with braces (orthodontic treatment). The hypothesis is that there is no difference in the number of cavities on the permanent teeth of patients with braces compared to similar patients without braces.

Study Overview

• Status: Completed
• Conditions: Dental Caries

Detailed Description

The purpose of this cross-sectional study is to determine the prevalence of early carious lesions (white spot lesions, or WSLs) for patients who are receiving orthodontic treatment compared to patients who are not receiving orthodontic treatment.

Subjects will be recruited from the University of Kentucky Orthodontic Clinic patient pool. Orthodontic care at the University of Kentucky College of Dentistry (UKCOD) is provided by orthodontic faculty, as well as students enrolled in the graduate orthodontic program at the UKCOD. Subjects will be invited to participate in this study after receiving an initial treatment plan with fixed appliances for at least one arch.

• Study Type: Observational
• Enrollment (Actual): 111

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536-0297
      • University of Kentucky College of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 70 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants have to be 10 years older who are treatment planned for orthodontic treatment with fixed appliances in the Graduate or Faculty Orthodontic Clinic at University of Kentucky.

Based upon the racial distribution of patients currently receiving treatment in the Graduate and Faculty Orthodontic Clinics, investigators expect that study population to be predominantly Caucasian, with minority representation from the African-American and Hispanic communities. The sample composition is expected to be equally weighted with respect to gender.

Description

Inclusion Criteria:

• Patients who agreed to participate in this study
• Patients who receive orthodontic treatment with fixed appliances at University of Kentucky College of Dentistry
• Patients who have either metal or ceramic brackets for the treatment

Exclusion Criteria:

• Patients on a daily supplemental fluoride regimen
• Patients who has difficulty in their daily toothbrushing due to their physical disability
• Patients with lingual fixed appliances
• Patients who are pregnant
• Patients with restorations placed on the facial/buccal surface of the tooth from premolar to premolar for both arches.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The formation of early caries lesion on teeth (white spot lesions)	Teeth of study subjects will be evaluated for the formation of white spot lesions based on their intraoral photographs taken at their participation for the study.	One-time assessment at participant visit (approximately 30 minutes).
The dental plaque deposit on teeth.	Teeth of study subjects will be stained with the plaque disclosing agent. After rinsing off the disclosing agent, intraoral photographs are taken for later analysis of dental plaque accumulation.	One-time assessment at participant visit (approximately 30 minutes).
Subjects' of attitude toward the oral hygiene practice.	Participants will be asked to take an electronic questionnaire (through REDCap) consisting of 13 items that assess their dental hygiene practice and attitude toward orthodontic treatment. Individual question responses range from 0-7 (cumulative range of 0-91) with higher scores indicating more positive attitudes.	One-time assessment at participant visit (approximately 30 minutes).

Collaborators and Investigators

• Sponsor: Hiroko Nagaoka
• Investigators: Principal Investigator: Hiroko Nagaoka, University of Kentucky

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2019
• Primary Completion (ACTUAL): October 31, 2019
• Study Completion (ACTUAL): October 31, 2019

Study Registration Dates

• First Submitted: June 24, 2019
• First Submitted That Met QC Criteria: December 3, 2019
• First Posted (ACTUAL): December 4, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 24, 2020
• Last Update Submitted That Met QC Criteria: June 22, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: lesions; tooth; white spot
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: 47148

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No