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Diastema Closure and Stability: Clear Aligners vs Fixed Appliances With Laser Frenectomy

NCT07778095 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-08-21

No results posted yet for this study

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.

Conditions

  • Diastema
  • Generalized Interdental Spaces

Interventions

DEVICE

Clear Aligners

Custom thermoplastic aligners worn 20-22 hours daily with sequential staged movements for space closure.

DEVICE

Fixed Orthodontic Appliance

Metal brackets with MBT 0.022-inch slot prescription and sequential archwires for controlled space closure.

PROCEDURE

Laser Frenectomy

Surgical ablation and tissue excision of the labial frenum performed using a soft-tissue diode laser.

Sponsors & Collaborators

  • Sana'a University

    lead OTHER

Principal Investigators

  • Ghamdan A Al-Harazi, PhD · Sana'a University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-11-30
Primary Completion
2028-12-31
Completion
2029-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07778095 on ClinicalTrials.gov