Evaluation of Treatment Outcome of Lower Incisors Crowding Using Clear Aligners With Laser Acceleration .

Not Applicable

Completed

• Conditions: Tooth Movement
• Interventions: Procedure: Low-Level Laser acceleration; Procedure: clear aligner therapy

• Registration Number: NCT06526871
• Lead Sponsor: Huda Abdelhakim

Brief Summary

The present study will be performed to evaluate the effect of low-level laser therapy (LLLT) on the rate of orthodontic tooth movement through the correction of lower incisors crowding using clear aligners

Detailed Description

This study will employ a two-arm parallel randomized clinical trial design with an allocation ratio of 1:1. The study will include participants aged 16 to 23 years with mild to moderate anterior lower crowding and Class I Angle malocclusion, presenting with a full set of teeth excluding wisdom teeth. Eligible participants will be randomly assigned to either the intervention group, receiving LLLT in addition to clear aligner therapy, or the control group, receiving clear aligner therapy alone.

Intervention:

The intervention group will undergo LLLT using the Biolase Epic X device, calibrated to 0.2 W power, 0.16 J energy, and 0.8 seconds pulse duration per point. The laser will be applied to five points on the buccal surface (cervical mesial, distal, middle root, apical mesial, and distal) and four points on the lingual surface (cervical mesial, distal, middle root, and middle apical) of the target tooth. LLLT sessions will be conducted weekly over seven sessions.

Study Timeline

• Study Start: 2022-10-25
• Primary Completion: 2024-06-02
• Status Verified: 2024-07
• Study Completion: 2024-07-03
• Study First Submitted: 2024-07-19
• Study First Submitted QC: 2024-07-24
• Last Update Submitted: 2024-07-24
• Study First Posted: 2024-07-30
• Last Update Posted: 2024-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 22

Inclusion Criteria

1. A well-behaved, compliant, and motivated patient.
2. Patients from 16 to 23 years old .
3. Patients with mild to moderate anterior lower crowding.
4. Full complement of teeth (except for wisdom teeth).
5. Class I Angle malocclusion .

Exclusion Criteria

1. Patients with missed anterior teeth .
2. Class II or III Malocclusion (dental or skeletal ) .
3. Any systemic diseases that may interfere with assigned treatment plan .
4. Periodontal affection especially at lower anterior teeth .

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Low-Level Laser acceleration	ten patients treated with removable clear aligner with application of Low-Level-Laser
control group	clear aligner therapy	ten patients treated with removable clear aligner
Experimental group	clear aligner therapy	ten patients treated with removable clear aligner with application of Low-Level-Laser

Primary Outcome Measures

Name	Time	Method
• Little irregularity index	through study completion, an average of 6 months	The Little Irregularity Index is a quantitative method used to assess the degree of dental crowding. It measures the linear displacement of the contact points of the mandibular anterior teeth (canine to canine) from their ideal positions. This measurement is taken before and after orthodontic treatment using scanned 3D models, allowing for an objective evaluation of alignment improvement.

Secondary Outcome Measures

Name	Time	Method
• Tooth movement accuracy	through study completion, an average of 6 months	This process involved aligning and overlaying 3D models to assess the extent and direction of tooth displacement over time.
• Treatment time	through study completion, an average of 6 months	The duration of orthodontic treatment, including active treatment phases such as wearing aligners or undergoing procedures like interproximal reduction, is crucially monitored. This active treatment time is distinct from overall treatment duration, which encompasses intervals such as retention phases or breaks between aligner changes.
• Number of aligners	through study completion, an average of 6 months	The number of aligners measurement involves determining the total quantity of clear aligners required for a patient's orthodontic treatment.
• Patient comfort and satisfaction	through study completion, an average of 6 months	Patient comfort and satisfaction were evaluated using standardized scales, including Visual Analog Scales (VAS) , to assess pain levels, oral discomfort, and overall treatment experience.
• Digital cast accuracy	through study completion, an average of 6 months	Digital cast accuracy was assessed using 3D surface comparison methods, comparing intraoral scans with traditional plaster models.
• Refinement rate	through study completion, an average of 6 months	The refinement rate in orthodontics refers to the frequency and extent of adjustments made to aligners or appliances during treatment to achieve optimal tooth alignment. It is typically measured by assessing the need for additional aligners,
• Software predictability	through study completion, an average of 6 months	3D models were superimposed to analyze the accuracy of predicted tooth movements compared to actual outcomes.

Trial Locations

Locations (1)

AL-Azhar university; 🇪🇬 Cairo, Egypt