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

Dental Caries Clinical Trial

— WSLs  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04186065
• Other study ID #: 47148
• Status: Completed
• Start date: March 1, 2019
• Est. completion date: October 31, 2019

Study information

• Verified date: June 2020
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: October 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Caries

Locations

Country	Name	City	State
United States	University of Kentucky College of Dentistry	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Hiroko Nagaoka

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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).
Primary	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).