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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05183451
Other study ID # FDCU-REC (2)/12-2018
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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Not yet recruiting NCT03074370 - Evaluation of Smile Esthetics in Orthodontically Treated Patients With Bimaxillary-dentoalveolar Protrusion N/A