Diastema Closure and Stability: Clear Aligners vs Fixed Appliances With Laser Frenectomy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-35
SponsorSana'a University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients aged 18 to 35 years.
Presence of maxillary median diastema associated with generalized interdental spacing (width >= 3 mm).
Fully erupted permanent teeth (excluding third molars).
Good periodontal health with probing depths <= 3 mm and no bone loss.
Disqualifiers
Previous orthodontic treatment.
Severe skeletal malocclusion or craniofacial anomalies.
Active periodontal disease, poor oral hygiene, or untreated caries.
Missing or impacted permanent teeth in the maxillary arch (excluding third molars).
Trial design
Design model
Factorial
Treatments tested in this trial
Clear Aligners
DeviceCustom thermoplastic aligners worn 20-22 hours daily with sequential staged movements for space closure.
Fixed Orthodontic Appliance
DeviceMetal brackets with MBT 0.022-inch slot prescription and sequential archwires for controlled space closure.
Laser Frenectomy
Procedure/SurgerySurgical ablation and tissue excision of the labial frenum performed using a soft-tissue diode laser.
Treatment groups
48 Participants
are divided into 4 treatment groupsGroup A: Clear Aligners with Laser FrenectomyExperimental treatment 2 interventions
Group B: Clear Aligners without Laser FrenectomyExperimental treatment 1 intervention
Group C: Fixed Appliances with Laser FrenectomyActive comparator 2 interventions
Group D: Fixed Appliances without Laser FrenectomyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Amount of Diastema Relapse
Linear measurement (in millimeters) of maxillary median diastema relapse evaluated on digital 3D models (obtained via intraoral scanner) to measure space reopening post-treatment.
Time frame
Baseline (0 months), 18 months, 24 months, 30 months, and 32 monthsSecondary outcomes
1
Rate and Efficiency of Diastema Closure
Total duration (months) to achieve complete space closure and the rate of space closure per month (mm/month) measured from digital 3D models.
Time frame
Up to 18 months2
Root Parallelism and Angulation Changes
Assessment of central incisor root parallelism and root position (bodily movement vs tipping) measured in degrees on digital periapical radiographs.
Time frame
Baseline and 18 months3
Labial Frenum Re-attachment Level
Linear measurement of labial frenum attachment level (in millimeters relative to the mucogingival junction).
Time frame
Baseline, 18 months, and 32 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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