Evaluation of Enamel Demineralization During Clear Aligner Orthodontic Treatment

Not Applicable

Completed

• Conditions: White Spot Lesion
• Interventions: Device: Orthodontic treatment with clear aligner

• Registration Number: NCT04107012
• Lead Sponsor: Jordan University of Science and Technology

Brief Summary

Development of white spot lesions (enamel demineralization) will be evaluated quantitatively during clear aligner orthodontic treatment compared to conventional fixed appliances using quantitative light induced fluorescence (QLF)

Detailed Description

White spot lesion (WSL) may develop around fixed orthodontic appliances. With clear aligners, however, the issue is not controversial. WSL will be monitored in 2 groups of patients; one group using clear aligners and one group wearing fixed orthodontic appliances for 3 months. QLF images will be taken before treatment (T0) and 3 months after commencement of the treatment (T1). The results will be compared between the two groups

Study Timeline

• Study Start: 2016-09
• Primary Completion: 2018-01
• Study Completion: 2018-09
• Study First Submitted: 2019-07-14
• Status Verified: 2019-09
• Study First Submitted QC: 2019-09-25
• Last Update Submitted: 2019-09-25
• Study First Posted: 2019-09-27
• Last Update Posted: 2019-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

• Healthy patients from both genders aged (17 - 24 years).
• Class I malocclusion with mild to moderate crowding (≤ 5 mm).
• Non-extraction treatment plan.
• Optimum oral Hygiene before treatment with no signs of gingivitis and/or periodontitis.
• Maximum of 3 restored teeth.
• Absence of defective enamel formation in the form of hypocalcification or hypoplasia.

Exclusion Criteria

-Patients with poor oral hygiene, defective enamel, extensive restorations and salivary glands diseases were excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fixed appliance	Orthodontic treatment with clear aligner	Group 2 treated with conventional fixed appliances
Clear Aligner	Orthodontic treatment with clear aligner	Group 1 treated with clear aligners

Primary Outcome Measures

Name	Time	Method
Lesion area	3 months	Incidence of the white spot lesion area
Delta F	3 months	Incideance of Fluorescence loss

Secondary Outcome Measures

Name	Time	Method
Number of new lesions	3 months	The number of newly developed white spot lesion during orthodontic treatment
ΔR30	3 months	Rate of plaque on tooth surfaces