Effect Of Low Level Laser Therapy on the Rate of En- Masse Retraction: RCT

December 21, 2021 updated by: Heba Mohamed El- Sayed Dehis, Cairo University

Effect of Low-level Laser Therapy on the Rate of En-masse Retraction in Adult Females With Bimaxillary Dentoalveolar Protrusion: a Single-center Randomized Clinical Trial

There is scarcity in the literature regrading the effect of Low Level Laser Therapy (LLLT) on the rate of en-masse retraction. This study aims to investigate whether LLLT would affect the rate of en-masse retraction in females having bimaxillary dento-alveolar protrusion.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Individuals having bimaxillary dentoalveolar protrusion are characterized by proclined upper and lower incisors and increased procumbency of the lips thus suffering from poor facial esthetics. The conventional management of these patients is the extraction of the first premolars and retraction of the anterior teeth.

One of the treatment techniques is in the form of canine retraction followed by four incisors retraction. This conventional method takes tedious work and tremendous time, thus affecting the patients' satisfaction adversely. The other technique is retraction of the whole set of anterior teeth as one unit (Canine and incisors), which is referred to as "En-Masse retraction".

Enhancing the rate of orthodontic tooth movement has always been a supreme goal of orthodontic research hoping to raise the level of care delivered to patients, hence, increase patients' satisfaction.

One of the proposed modalities of increasing the rate of tooth movement is Low Level Laser Therapy (LLLT). Thus, the aim of the current consideration was to evaluate the impact of LLLT on the rate of en-masse retraction in adult females having bimaxillary dentoalveolar protrusion.

Study Type

Interventional

Enrollment (Actual)

32

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
        • Cairo 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

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Adult females
  • Patients having bimaxillary dento- alveolar protrusion and Class I Molar relation
  • Cases requiring maximum anchorage during retraction.
  • Good general and oral health

Exclusion Criteria:

  • Patients suffering from any systemic diseases interfering with tooth movement.
  • Patients with extracted or missing permanent teeth. (except for third molars).
  • Patients with badly decayed teeth (Other than 1st premolars).
  • Patients with any parafunctional habits (i.e. Bruxism, tongue thrusting, mouth breathing, etc…).
  • Patients with previous orthodontic treatment
  • Pregnant females

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: LG (Group A)
En- masse retraction using NiTi closed coil springs rendering 200 g/side were employed following first premolars extraction and insertion of buccal TADs to provide maximum anchorage. Retraction was done along with the application of LLLT till the end of retraction.
Procedure: En- masse retraction and LLLT
Retraction will start on a 0.019"x0.025" Stainless steel wire using NiTi closed coils (force applied will be 200 g per side) extending between the crimpable hooks and the TADs. LLLT will be applied on days 0,3,7,14 from extraction then repeated biweekly till the end of retraction.
Other Names:
  • Group A
  • Laser group
Active Comparator: NLG (Group B)
En- masse retraction using NiTi closed coil springs rendering 200 g/side were employed following first premolars extraction and insertion of buccal TADs to provide maximum anchorage. No LLLT was applied to this group
Procedure: En- masse retraction without LLLT
Retraction will start on a 0.019"x0.025" Stainless steel wire using NiTi closed coils (force applied will be 200 g per side) extending between the crimpable hooks and the TADs.
Other Names:
  • Group B
  • No laser group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of en-masse retraction
Time Frame: From date of first premolars' extraction until the date of anterior teeth retraction, assessed up to an average of 1 year
The antero-posterior movement of anterior teeth will be assessed by measuring the digitilized study models taken of the patients monthly (measured in mm)
From date of first premolars' extraction until the date of anterior teeth retraction, assessed up to an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anterior teeth's root resorption
Time Frame: From date of first premolars' extraction until the date of anterior teeth retraction, assessed up to an average of 1 year
Assessed via comparing the pre & post- retraction CBCTs using Lavender & Malmgren Grading system
From date of first premolars' extraction until the date of anterior teeth retraction, assessed up to an average of 1 year
Anterior teeth Tip and Torque
Time Frame: From date of first premolars' extraction until the date of anterior teeth retraction, assessed up to an average of 1 year
By comparing angular changes in the teeth's tip and torque in relation to reference planes
From date of first premolars' extraction until the date of anterior teeth retraction, assessed up to an average of 1 year
Anchorage (Loss/ Gain)
Time Frame: From date of first premolars' extraction until the date of anterior teeth retraction, assessed up to an average of 1 year
By comparing linear and angular changes in the first molars in relation to reference planes
From date of first premolars' extraction until the date of anterior teeth retraction, assessed up to an average of 1 year
First molars' rotation
Time Frame: From date of first premolars' extraction until the date of anterior teeth retraction, assessed up to an average of 1 year
Study models that are taken pre and post retraction (then digitilized) will be used to assess the rotation of the maxillary first molars in relation to a reference line
From date of first premolars' extraction until the date of anterior teeth retraction, assessed up to an average of 1 year
Pain Associated
Time Frame: From date of first premolars' extraction until the date of anterior teeth retraction, assessed up to an average of 1 year
Each patient will fill a questionnaire regarding his treatment experience in a VAS scoring from 0-10
From date of first premolars' extraction until the date of anterior teeth retraction, assessed up to an average of 1 year

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Principal Investigator: Heba Mohamed E Dehis, Lecturer, Cairo University
  • Study Director: Foad A El-Sharaby, A. Professor, Cairo University
  • Study Director: Faten H Eid, Professor, Cairo University
  • Study Director: Mushira Dahaba, Professor, Cairo University
  • Study Director: Yehya A Mostafa, Professor, Future University in Egypt (FUE)

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 2, 2018

Primary Completion (Actual)

August 20, 2020

Study Completion (Actual)

October 25, 2020

Study Registration Dates

First Submitted

December 5, 2021

First Submitted That Met QC Criteria

December 21, 2021

First Posted (Actual)

January 10, 2022

Study Record Updates

Last Update Posted (Actual)

January 10, 2022

Last Update Submitted That Met QC Criteria

December 21, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FDCU-REC (2)/12-2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Research data will be available for researchers who provide a methodologically sound proposal.

Proposals should be directed to the corresponding author. To gain access, data requestors will need to sign a data access agreement.

IPD Sharing Time Frame

Data will be available immediately following publication and ending 6 months following article publication

IPD Sharing Access Criteria

Data will be available after contact with the corresponding author

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

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.

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