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

Completed

• Conditions: Dental Caries

• Registration Number: NCT04186065
• Lead Sponsor: Hiroko Nagaoka

Brief Summary

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.

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 Timeline

• Study Start: 2019-03-01
• Study First Submitted: 2019-06-24
• Primary Completion: 2019-10-31
• Study Completion: 2019-10-31
• Study First Submitted QC: 2019-12-03
• Study First Posted: 2019-12-04
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-22
• Last Update Posted: 2020-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The dental plaque deposit on teeth.	One-time assessment at participant visit (approximately 30 minutes).	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.
The formation of early caries lesion on teeth (white spot lesions)	One-time assessment at participant visit (approximately 30 minutes).	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.
Subjects' of attitude toward the oral hygiene practice.	One-time assessment at participant visit (approximately 30 minutes).	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.

Trial Locations

Locations (1)

University of Kentucky College of Dentistry; 🇺🇸 Lexington, Kentucky, United States