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

NCT ID: NCT05183451

Last Updated: 2022-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-02

Study Completion Date

2020-10-25

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Bimaxillary Protrusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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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.

Group Type EXPERIMENTAL

En- masse retraction and LLLT

Intervention Type 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.

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

Group Type ACTIVE_COMPARATOR

En- masse retraction without LLLT

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

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Laser group Group A No laser group Group B

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Heba Mohamed El- Sayed Dehis

Lecturer of Orthodontics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Heba Mohamed E Dehis, Lecturer

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Foad A El-Sharaby, A. Professor

Role: STUDY_DIRECTOR

Cairo University

Faten H Eid, Professor

Role: STUDY_DIRECTOR

Cairo University

Mushira Dahaba, Professor

Role: STUDY_DIRECTOR

Cairo University

Yehya A Mostafa, Professor

Role: STUDY_DIRECTOR

Future University in Egypt (FUE)

Locations

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Cairo University

Cairo, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type DERIVED
PMID: 38842738 (View on PubMed)

Other Identifiers

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FDCU-REC (2)/12-2018

Identifier Type: -

Identifier Source: org_study_id

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