Clear Aligner Treatment With and Without Low Level Laser Therapy for Upper Incisor Crowding

Not Applicable

Completed

• Conditions: Crowding of Anterior Maxillary Teeth
• Interventions: Procedure: Clear Aligner Treatment; Procedure: Low level laser

• Registration Number: NCT06493721
• Lead Sponsor: Faculty of Dental Medicine for Girls

Brief Summary

The goal of this clinical trial is to assess the effect of Low Level Laser Therapy (LLLT) on Upper Incisor Crowding using Clear Aligner Treatment (CAT).

Detailed Description

The goal of this clinical trial is to assess the effect of Low Level Laser Therapy (LLLT) on Upper Incisor Crowding using Clear Aligner Treatment (CAT) on healthy patients (16-23 years old) with complete set of dentition and Angle class I. The main questions to answer are:

1. Evaluate rate of Upper Incisor Decrowding using CAT and LLLT

2. Does LLLT affect pain during CAT?

Researchers will compare CAT with LLLT to CAT without LLLT to see if the LLLT will accelerate Orthodontic Tooth Movement.

Participants will:

* Change to a new aligner every 7 days.

* Visit the clinic every week for checkup.

* Log in pain scores every 6, 24, 48 and 72 hours after delivery of new aligners.

Study Timeline

• Study Start: 2022-12-15
• Primary Completion: 2024-06-28
• Study Completion: 2024-06-28
• Study First Submitted: 2024-06-29
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-09
• Last Update Submitted: 2024-07-09
• Study First Posted: 2024-07-10
• Last Update Posted: 2024-07-10

Recruitment & Eligibility

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

Inclusion Criteria

1. Patients age ranging from 16-23 years old with Angle class I malocclusion and upper anterior crowding.
2. Healthy, compliant and internally motivated patient.
3. Full set of maxillary permanent dentition except third molar.

Exclusion Criteria

1. Previous orthodontic treatment.
2. Any systemic diseases that could interfere with orthodontic treatment.
3. Gross gingival or periodontal problems

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low level laser	Clear Aligner Treatment	Clear aligner therapy with low level laser therapy
Clear aligner only	Clear Aligner Treatment	Clear aligner therapy group only
Low level laser	Low level laser	Clear aligner therapy with low level laser therapy

Primary Outcome Measures

Name	Time	Method
Rate of tooth movement	Initial alignment at the end of 3rd month during treatment planning of clear aligner	Calculate rate of anterior incisor decrowding using digital measurement in millimetre

Secondary Outcome Measures

Name	Time	Method
Pain level	Initial alignment at the end of 3rd month phase during treatment planning of clear aligner	Will Low Level Laser Therapy decrease pain levels during clear aligner treatment. Evaluated using Numerical Rating Scale

Trial Locations

Locations (1)

Faculty of Dental Medicine for Girls Al-Azhar University; 🇪🇬 Cairo, Egypt