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

July 24, 2024 updated by: Huda Abdelhakim

Evaluation of Treatment Outcome of Lower Incisors Crowding Using Clear Aligners With Laser Acceleration (Randomized Control Study) .

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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
        • 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

No

Description

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 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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: control group
ten patients treated with removable clear aligner
Procedure: clear aligner therapy
Clear aligner therapy involves using a series of custom-made, clear plastic aligners to gradually move teeth into their desired positions. These aligners are worn over the teeth and are typically changed every week as the teeth gradually shift. The treatment process starts with a digital scan or impression of the teeth, which is used to create a 3D model. This model helps in planning the precise movements needed to achieve proper alignment. Throughout the treatment, patients visit their orthodontist periodically to monitor progress and receive new sets of aligners. Clear aligners are popular for their aesthetic appeal and the convenience they offer compared to traditional braces.
Experimental: Experimental group
ten patients treated with removable clear aligner with application of Low-Level-Laser
Procedure: clear aligner therapy
Clear aligner therapy involves using a series of custom-made, clear plastic aligners to gradually move teeth into their desired positions. These aligners are worn over the teeth and are typically changed every week as the teeth gradually shift. The treatment process starts with a digital scan or impression of the teeth, which is used to create a 3D model. This model helps in planning the precise movements needed to achieve proper alignment. Throughout the treatment, patients visit their orthodontist periodically to monitor progress and receive new sets of aligners. Clear aligners are popular for their aesthetic appeal and the convenience they offer compared to traditional braces.
Procedure: Low-Level Laser acceleration
This intervention involves the application of Low-Level Laser Therapy (LLLT) using the Epic X device for patients undergoing orthodontic treatment. The protocol is designed to assess the effects of LLLT on pain reduction and treatment efficacy during the initial leveling and alignment phase of orthodontic therapy using clear aligners .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
• Little irregularity index
Time Frame: 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.
through study completion, an average of 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
• Treatment time
Time Frame: 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.
through study completion, an average of 6 months
• Number of aligners
Time Frame: 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.
through study completion, an average of 6 months
• Patient comfort and satisfaction
Time Frame: 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.
through study completion, an average of 6 months
• Refinement rate
Time Frame: 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,
through study completion, an average of 6 months
• Digital cast accuracy
Time Frame: 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.
through study completion, an average of 6 months
• Tooth movement accuracy
Time Frame: 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.
through study completion, an average of 6 months
• Software predictability
Time Frame: through study completion, an average of 6 months
3D models were superimposed to analyze the accuracy of predicted tooth movements compared to actual outcomes.
through study completion, an average of 6 months

Collaborators and Investigators

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

Sponsor

Huda Abdelhakim

Investigators

  • Principal Investigator: Samir A Ibrahim, professor, Al-Azhar University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 25, 2022

Primary Completion (Actual)

June 2, 2024

Study Completion (Actual)

July 3, 2024

Study Registration Dates

First Submitted

July 19, 2024

First Submitted That Met QC Criteria

July 24, 2024

First Posted (Actual)

July 30, 2024

Study Record Updates

Last Update Posted (Actual)

July 30, 2024

Last Update Submitted That Met QC Criteria

July 24, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ORTHO-109-2-K

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Yes

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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