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

Qualifiers

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

Treatments tested in this trial

  • Clear Aligners
  • Fixed Orthodontic Appliance
  • Laser Frenectomy

Treatment groups

48 Participants
are divided into 4 treatment groups

Locations

This trial has no locations

Sponsors and collaborators