Effectiveness of a clinical guideline to improve the dental health in orthodontic patients with fixed appliances: study protocol for a cluster randomized trial

Conditions: Enamel carious lesions, white spot, prevention, guideline, effectivness, orthodontic treamtent.Ontkalkingen, richtlijn, effectiviteit, preventie, orthodontische behandeling.

Registration Number: NL-OMON24400

Lead Sponsor: Radboud University Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Other

Sex: Not specified

Target Recruitment: 840

Inclusion Criteria

All patients between 12 and 18 years of age, with fully erupted permanent dentition, who are scheduled for treatment with full fixed appliances, are eligible to participate in this study.

Exclusion Criteria

-Patients younger than 12 years of age because they do not have a fully erupted dentition, patients older than 18 years of age because after this age the risk of development of WSLs is reduced.

-Patient diagnosed with astma bronchiale because the use of Durphat is contra-indicated.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome<br /><br><br>The primary outcome measure is the incidence of WSLs after 6 to 9 months of treatment with fixed appliances and at the end of treatment using the CPG for prevention of WSLs compared to usual preventive measures in patients treated with full fixed orthodontic appliances.<br>

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes<br /><br><br>Secondary outcome is adoption of the CPG in routine clinical orthodontic practice. This will be measured in terms of :<br /><br><br>-Professionals attitude toward working with the CPG for prevention of WSLs, measured by means of a questionnaire.<br /><br><br>-Professionals compliance with key recommendations in the CPG for prevention of WSLs, measured by auditing the EPF.<br>-Patients views on the preventive care provided, measured by means of an questionnaire .<br>