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Completed

NCT Number: NCT04186065

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.

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Key information

Age range

10 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Kentucky College of Dentistry

Lexington, Kentucky, 40536-0297, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. The formation of early caries lesion on teeth (white spot lesions)

    Time frame: 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.

  2. The dental plaque deposit on teeth.

    Time frame: 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.

  3. Subjects' of attitude toward the oral hygiene practice.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hiroko Nagaoka

Other

Registry information

Official study title

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

Acronym: WSLs

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 4, 2019
Registry last updated
Jun 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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