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Diastema Closure and Stability: Clear Aligners vs Fixed Appliances With Laser Frenectomy
Sponsor: Sana'a University
Summary
This study is a prospective 2x2 factorial randomized clinical trial designed to evaluate and compare the closure efficiency and post-treatment stability of diastema associated with generalized interdental spacing (width \>= 3 mm) treated with clear aligners versus fixed orthodontic appliances, with and without adjunctive laser frenectomy. Participants are randomized into four treatment arms to assess the main effects and interaction effects of appliance modality and laser frenectomy. Stability and relapse rates are systematically tracked across active treatment, a 6-month retention period, and post-retention follow-up intervals at 6 and 8 months.
Official title: Closure and Stability of Diastema Associated With Generalized Interdental Spacing Using Clear Aligners Versus Fixed Appliances With Adjunctive Frenectomy: A 2x2 Factorial RCT
Key Details
Gender
All
Age Range
18 Years - 35 Years
Study Type
INTERVENTIONAL
Enrollment
48
Start Date
2026-11
Completion Date
2029-01
Last Updated
2026-08-21
Healthy Volunteers
No
Conditions
Interventions
Clear Aligners
Custom thermoplastic aligners worn 20-22 hours daily with sequential staged movements for space closure.
Fixed Orthodontic Appliance
Metal brackets with MBT 0.022-inch slot prescription and sequential archwires for controlled space closure.
Laser Frenectomy
Surgical ablation and tissue excision of the labial frenum performed using a soft-tissue diode laser.