Diastema Closure and Stability: Clear Aligners vs Fixed Appliances With Laser Frenectomy | NCT07778095 | Trialant

Not yet recruitingInterventionalNot ApplicableUpdated Aug 21, 2026

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

Closure and Stability of Diastema Associated With Generalized Interdental Spacing Using Clear Aligners Versus Fixed Appliances With Adjunctive Frenectomy: A 2x2 Factorial RCT

Overview

Key facts that identify this study and show where it stands today.

ClinicalTrials.gov ID: NCT07778095
Lead Sponsor: Sana'a UniversityOTHER
Overall Status: Not yet recruiting
Study Type: Interventional
Phase: Not Applicable
Enrollment: 48Estimated
Last Update Posted: Aug 21, 2026Actual
Start Date: Nov 2026Estimated
Primary Completion Date: Dec 2028Estimated
Completion Date: Jan 2029Estimated

Description

What the study is about and why it is being run, in the researchers' own words.

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
Brief 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.
Detailed Description

Conditions

The medical conditions and diseases this study investigates.

Diastema
Generalized Interdental Spaces

Interventions

The treatments and procedures being evaluated in this study.

Clear Aligners
Fixed Orthodontic Appliance
Laser Frenectomy

Participation

Who can join this study and the criteria used to decide.

Ages Eligible for Study: Adult (18-64)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

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.

High motivation and commitment to follow treatment protocols and compliance.

Written informed consent provided.

Exclusion Criteria:

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).

Systemic diseases or long-term medication use affecting bone metabolism or tooth movement (e.g., bisphosphonates, systemic corticosteroids).

Pregnant or lactating females.

Heavy smokers or individuals with severe parafunctional

Design

How the study is designed and how its participant groups are organized.

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Factorial Assignment
Masking: None (Open Label)

Contacts

The people to reach with questions about this study or how to join it.

Seham Abdulghani Hamood Alokam, BDS, MScContact

SEHAM.AL_OKAM@su.edu.ye00967738718234

Locations

Where the study is run and whether each site is currently recruiting.

No locations

There are no locations for this study.

Collaborators

The organizations and people involved in this study.

Lead Sponsor: Sana'a UniversityOTHER

Similar Studies

Other registered studies that closely resemble this one.

Diastema associated with generalized interdental spacing (>= 3 mm) represents a challenging orthodontic condition with a heightened risk of post-treatment relapse. While fixed appliances provide reliable three-dimensional tooth movement control, clear aligners offer improved esthetics and patient comfort. Additionally, the role and timing of adjunctive laser frenectomy in stabilizing space closure remain controversial in generalized spacing cases.

This prospective 2x2 factorial randomized clinical trial is conducted at the Orthodontic Clinics, Faculty of Dentistry, Sana'a University, Yemen. A total of 48 eligible participants are randomly allocated into four equal groups (n=12 per group):

Group 1: Clear Aligner Therapy with Adjunctive Laser Frenectomy
Group 2: Clear Aligner Therapy without Frenectomy
Group 3: Fixed Orthodontic Appliance with Adjunctive Laser Frenectomy
Group 4: Fixed Orthodontic Appliance without Frenectomy

Treatment Protocols:

Clear Aligner Group: Digital intraoral scans are obtained using a Zahndent scanner. Virtual treatment planning ensures sequential space closure with root control. Aligners are manufactured by Dentalign Company (Sana'a, Yemen) and worn 20-22 hours daily.
Fixed Appliance Group: Treated using MBT prescription brackets with a 0.022-inch slot. The archwire sequence includes initial leveling with 0.012 to 0.018 NiTi wires, followed by rectangular stainless steel wires (0.016x0.022, 0.017x0.025, and 0.019x0.025 inches) for space closure and torque control.
Auxiliary Mechanics: Cervical buttons are bonded in selected teeth across aligner and fixed groups to enhance bodily movement control.
Adjunctive Laser Frenectomy: Performed using standardized laser technique following partial or complete space closure in designated groups.

Retention and Evaluation:

All participants follow a standardized retention protocol for 6 months post-treatment. Clinical, digital (Zahndent intraoral scanner), and radiographic (digital periapical sensor) assessments are conducted at five measurement time points:

T0: Baseline (pre-treatment)
T1: End of active orthodontic treatment
T2: End of retention period (6 months)
T3: 6 months post-retention
T4: 8 months post-retention

The primary outcome is the amount of diastema relapse (mm). Secondary outcomes include total space closure, root parallelism, and relapse rates.