Clinical trial NCT04186065: The Prevalence of White Spot Lesions During Orthodontic Treatment With Fixed Appliances
Official title: Cross-Sectional Study: The Prevalence of White Spot Lesions During Orthodontic Treatment With Fixed Appliances
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Caries
Keywords: white spot
lesions
tooth
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2019-12-04
Enrollment: 111
Sex: ALL
Minimum age (years): 10
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The formation of early caries lesion on teeth (white spot lesions)
timeFrame: One-time assessment at participant visit (approximately 30 minutes).
measure: The dental plaque deposit on teeth.
timeFrame: One-time assessment at participant visit (approximately 30 minutes).
measure: Subjects' of attitude toward the oral hygiene practice.
timeFrame: One-time assessment at participant visit (approximately 30 minutes).
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky College of Dentistry
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Hiroko Nagaoka
role: PRINCIPAL_INVESTIGATOR
References: