Effect of Low-level Laser Therapy on Orthodontic Tooth Movement

September 21, 2022 updated by: Beren Özsoy, Near East University, Turkey

Effect of Low-level Laser Therapy on Orthodontic Tooth Movement During Miniscrew-supported Maxillary Molar Distalization in Humans: A Single-blind, Randomized Controlled Clinical Trial

The objective of this trial is to investigate the effect of low-level laser therapy (LLLT) on orthodontic tooth movement during maxillary molar distalization over 12-week observation period.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The duration of orthodontic treatment may be prolonged depending on many factors such as the ratio of bone remodeling, the tooth anchorage, the type of applied mechanics, patient cooperation, and the necessity of keeping the applied forces during the treatment within physiological limits.1-7 Prolonged treatment might affect the psychosocial status of the patient and might lead to a decrease in the level of patient cooperation, and increase the risk of developing a pathological incident such as dental caries, periodontal diseases, alveolar bone resorption and root resorption due to insufficient oral hygiene.8-10 Increasing the intensity of the applied force in an attempt to accelerate tooth movement will cause closure of the blood vessels, and necrosis in the periodontal ligament, and will lead to inhibition of any cellular activity, which is also known as hyalinization.3-7 Various approaches such as local-systemic drug administration, mechanical-physical stimulations, and surgically-assisted approaches aimed at reducing the resistance of periodontal tissues against tooth movement and the effect of changing environmental factors have been developed to accelerate tooth movement and shorten the treatment period without increasing the intensity of the orthodontic force.2 LLLT (low-level laser therapy ) is one of the methods used for tooth movement therapy. Due to its non-invasive nature, safety, accessibility and bio-stimulating effects, LLLT is considered to be a promising tool for the future of dentistry.10 LLLT is currently being used to help speed up the ratio of bone formation in the suture after rapid maxillary expansion,18 reduce pain after orthodontic activation,19-21 and accelerate tooth movement19-32 in orthodontic clinical practices. In the literature, many of the experimental and clinical studies conducted to accelerate tooth movement by using the bio-stimulating effect of laser have demonstrated that tooth movement can be accelerated with LLLT.20-26 When compared with the previously mentioned approaches, no study has yet been found reporting any negative systemic effects of LLLT so far. It has been stated that there is a need for clinical trials to investigate the effects of non-invasive approaches that have the potential to accelerate tooth movement in different dentoalveolar regions.33 In this context, no previous study examined the effects of LLLT on maxillary molar distalization using a miniscrew-supported intraoral appliance. The aim of this study is to examine the contribution and effects of LLLT on orthodontic tooth movement during maxillary molar distalization using a miniscrew-supported intraoral appliance when compared with the control group.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Cyprus
      • Nicosia, Cyprus
        • Beren Özsoy

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 22 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Skeletal class I or mild class II malocclusion,

    • No untreated decayed teeth,
    • Normodivergent skeletal pattern,
    • Fully erupted maxillary first and second molars,
    • Male and female individuals between the ages of 16 and 22,
    • Extracted or congenitally missing maxillary third molars,
    • Non smoker,
    • No alveolar bone loss or periodontal disease,
    • Bilateral class II molar relationship,
    • Absence of crowding or spacing in the posterior region,
    • Adequate oral hygiene.
    • No drug usage that may have an impact on the biology of tooth movement (Example; Non-steroidal anti-inflammatory drugs- NSAIDS)

Exclusion Criteria:

  • • Hypodivergent or hyperdivergent skeletal pattern,

    • Alveolar bone loss or periodontal disease,
    • Systemic illnesses that might affect bone metabolism,
    • Any drug use that may have an impact on the biology of tooth movement (Example; Non-steroidal anti-inflammatory drugs- NSAIDS),
    • Inadequate oral hygiene,
    • Unilateral class II molar relationship,
    • Smoker,
    • Severe class II skeletal malocclusion (ANB>7°),
    • Crowding or spacing in the posterior region,
    • Missing maxillary second molars,
    • Existence of maxillary third molars,
    • Having untreated decayed 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: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention (Laser group)
The participants in the intervention group experienced a total of 7 session laser applications on their randomly determined molar region during the 12-week clinical trial period.
Device: Low Level Laser therapy
The participants in the intervention group experienced a total of 7 session laser applications on their randomly determined molar region during the 12-week clinical trial period.
No Intervention: Contralateral (Non-laser group)
Laser was not applied to the contralateral side of the intervention group (n=10) and the individuals in the control group (n=10); thus, no application was made to accelerate tooth movement
No Intervention: Control (Non-laser group)
Laser was not applied to the contralateral side of the intervention group (n=10) and the individuals in the control group (n=10); thus, no application was made to accelerate tooth movement

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Amount of maxillary molar distalization
Time Frame: 84 days after
Measurements were made using miniscrew as a reference point. Digital measurements were made on Geomagic Studio 2014 software to evaluate the amount of maxillary molar distalization. All 3D digital model measurements were coded, and the same researcher carried out two separate measurements 1-week apart to increase the reliability of the measurements. Parallelism was ensured between the dental arch and the Y-axis on the side where the measurements would be made by guiding the models. The parallelism of the dental arch to the Y-axis was also assessed from the lateral view. The midpoint of the first miniscrew and the mesial edge of the maxillary first molar were marked in the occlusal view. Then the distance between the projections of these two reference points to the Y-axis was measured. The difference between the two consecutive measurements indicated the 3-week amount of distalization in T1, T2, T3 and T4. This procedure was applied on both sides of all 3D models
84 days after

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Near East University, Turkey

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 29, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 14, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 15, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 22, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 22, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NearEastU-001

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

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings