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NCT Number: NCT05183451

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

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.

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Key information

Conditions

Bimaxillary Protrusion

Age range

18 year–30 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Laser group, 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.

Other names: No laser group, Group B

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 10, 2022
Registry last updated
Jan 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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