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

Bimaxillary Protrusion Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05183451
• Other study ID #: FDCU-REC (2)/12-2018
• Status: Completed
• Phase: N/A
• Start date: December 2, 2018
• Est. completion date: October 25, 2020

Study information

• Verified date: December 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 25, 2020
• Est. primary completion date: August 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Bimaxillary Protrusion

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Anterior teeth's root resorption	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
Secondary	Anterior teeth Tip and Torque	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
Secondary	Anchorage (Loss/ Gain)	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
Secondary	First molars' rotation	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
Secondary	Pain Associated	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