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

NCT04186065 | Completed

• 1 other identifier: 47148
• Study Type: observational
• Target: 111
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries

Keywords

white spot; lesions; tooth

Outcome Measures

Primary Outcomes (3)

• 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).

Eligibility Criteria

• Age: 10 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hiroko Nagaoka: lead

Study Sites (1)

University of Kentucky College of Dentistry

Lexington, Kentucky, 40536-0297, United States

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Hiroko Nagaoka

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Special Faculty

Study Record Dates

• First Submitted: June 24, 2019
• First Posted: December 4, 2019
• Study Start: March 1, 2019
• Primary Completion: October 31, 2019
• Study Completion: October 31, 2019
• Last Updated: June 24, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)