White Spot Lesion Clinical Trial
— WSLOfficial title:
The Effect of Fluoride Varnish, Casein Phosphopeptide-Amorphous Calcium Phosphate, and Resin Infiltration in the Treatment of White Spot Lesions After Orthodontic Therapy: A Randomized Controlled Trial
The study aims to investigate the effectiveness of a new treatment for demineralized white spot lesions (WSLs) after fixed appliance therapy. The trial will consist of four parallel groups: control, Fluoride Varnish (FV), Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP), and Resin Infiltration (RI) groups. Patients will be recruited from Riyadh Elm University's electronic record system and contacted by phone. They will be given an appointment to visit the dental clinic. A total of 22 patients with WSLs will be selected for the study. Two examiners will perform dental examinations using a dental mirror and a ball-ended probe to code the WSL against the ICDAS system. The level of agreement between the two examiners will be assessed using reliability analysis, with an agreement level of above 80% considered. Buccal WSLs will be defined as those that extend from the center of the buccal to either the mesial or distal surface. WSLs coded 3 or higher will be excluded from further examination and treated accordingly.
Status | Not yet recruiting |
Enrollment | 88 |
Est. completion date | March 2024 |
Est. primary completion date | February 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: 1. Post orthodontic patients with one WSLs on buccal surface of tooth with ICDAS Code 1 or 2. 2. Agreeing to participate in the study by singing the study informed consent. 3. For younger patients parents agree to provide consent for child participation in the study. Exclusion Criteria: 1. Developmental defects of dental hard tissue 2. Patients who have systemic disease or under medications that usually cause an increased risk of oral caries. 3. Patients who are allergic to Fluoride varnish, CPP-ACP and resin infiltration. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Riyadh Elm University |
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Nascimento PL, Fernandes MT, Figueiredo FE, Faria-E-Silva AL. Fluoride-Releasing Materials to Prevent White Spot Lesions around Orthodontic Brackets: A Systematic Review. Braz Dent J. 2016 Jan-Feb;27(1):101-7. doi: 10.1590/0103-6440201600482. — View Citation
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* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in mineral contents of enamel | The maximum light fluorescence value for each tooth with a white spot lesion will be determined using a DIAGNODent flat tip, following manufacturer's instructions. The DIAGNOdent scale will be used to measure the mineral content of enamel, with values ranging from 0 to 20. | Baseline pre-treatment (T1), immediately post-treatment (T2), and three months post-treatment (T3) |
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