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

July 9, 2024 updated by: Nada Ashraf Ali, Faculty of Dental Medicine for Girls

Clear Aligner Treatment for Upper Incisor Crowding With Low-Level Laser Therapy: A Comparative Clinical Study

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11787
        • Faculty of Dental Medicine for girls Al-Azhar University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Clear aligner only
Clear aligner therapy group only
Procedure: Clear Aligner Treatment
Clear aligner therapy to treat incisors crowding
Experimental: Low level laser
Clear aligner therapy with low level laser therapy
Procedure: Clear Aligner Treatment
Clear aligner therapy to treat incisors crowding
Procedure: Low level laser
Apply clear aligner therapy with low level laser application on incisors

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of tooth movement
Time Frame: 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
Initial alignment at the end of 3rd month during treatment planning of clear aligner

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain level
Time Frame: 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
Initial alignment at the end of 3rd month phase during treatment planning of clear aligner

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Faculty of Dental Medicine for Girls

Investigators

  • Study Director: Samir Abdo, Faculty of Dental Medicine, Girls Branch, Al Azhar University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2022

Primary Completion (Actual)

June 28, 2024

Study Completion (Actual)

June 28, 2024

Study Registration Dates

First Submitted

June 29, 2024

First Submitted That Met QC Criteria

July 9, 2024

First Posted (Actual)

July 10, 2024

Study Record Updates

Last Update Posted (Actual)

July 10, 2024

Last Update Submitted That Met QC Criteria

July 9, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ORTHO-109-2-M

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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