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

NCT05183451 | Completed DMC

• 1 other identifier: FDCU-REC (2)/12-2018
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bimaxillary Protrusion

Keywords

En-masse retraction; Rate of tooth movement; Low Level Laser Therapy (LLLT); 3D

Outcome Measures

Primary Outcomes (1)

• Rate of en-masse retraction

  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 Outcomes (5)

• Anterior teeth's root resorption

  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

  From date of first premolars' extraction until the date of anterior teeth retraction, assessed up to an average of 1 year

• Anchorage (Loss/ Gain)

  From date of first premolars' extraction until the date of anterior teeth retraction, assessed up to an average of 1 year

• First molars' rotation

  From date of first premolars' extraction until the date of anterior teeth retraction, assessed up to an average of 1 year

• Pain Associated

  From date of first premolars' extraction until the date of anterior teeth retraction, assessed up to an average of 1 year

Study Arms (2)

LG (Group A)

EXPERIMENTAL

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

NLG (Group B)

ACTIVE COMPARATOR

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

Interventions

En- masse retraction and LLLT PROCEDURE

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.

Also known as: Laser group, Group A

LG (Group A)

En- masse retraction without LLLT PROCEDURE

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.

Also known as: No laser group, Group B

NLG (Group B)

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

Related Publications (1)

• Dehis HM, El Sharaby FA, Eid FH, Mostafa YA. Effect of low-level laser therapy on en masse retraction in females with bimaxillary dentoalveolar protrusion : A single-center randomized clinical trial. J Orofac Orthop. 2025 Sep;86(5):284-297. doi: 10.1007/s00056-024-00525-2. Epub 2024 Jun 6.

  PMID: 38842738 DERIVED

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Heba Mohamed E Dehis, Lecturer

  Cairo University

  PRINCIPAL INVESTIGATOR

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention neither the operator nor the patients could be blinded. The assessors will be blinded from the data to be investigated he will just measure the data needed without knowing the purpose of the study, and without knowing which records belong to which group. Two assessors will carry out the the analysis of the study, blindly and independently.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Orthodontics

Study Record Dates

• First Submitted: December 5, 2021
• First Posted: January 10, 2022
• Study Start: December 2, 2018
• Primary Completion: August 20, 2020
• Study Completion: October 25, 2020
• Last Updated: January 10, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available immediately following publication and ending 6 months following article publication
• Access Criteria: Data will be available after contact with the corresponding author

Locations

EG (1)