Effect of Laser Therapy Versus Anterior Re-positioning Splint in the Treatment of Disc Displacement With Reduction

NCT ID: NCT03576079

Last Updated: 2018-07-03

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-01

Study Completion Date

2018-06-01

Brief Summary

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comparing the effects of Laser therapy with anterior re-positioning splint and a placebo group on clinical signs and symptoms of temporo-mandibular dis-function and assessing articular disc morphology and configuration with magnetic resonance imaging.

Detailed Description

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to compare the clinical effects of Laser therapy as assessed with research diagnostic criteria of temporo-mandibular disorders to a group that received anterior re-positioning splint therapy and a control group that received placebo Laser. Diagnosis for disc displacement with reduction was performed with magnetic resonance imaging before treatment. assessment of the clinical and MRI findings was again performed after a 3 months observation period.

Conditions

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Temporomandibular Joint Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Laser therapy

12 laser sessions over 3 months

Group Type EXPERIMENTAL

Laser therapy

Intervention Type DEVICE

epic model biolase with an output of 4W, 1800 J wavelength with a continuous Laser mode.

anterior re-positioning splint therapy

anterior re-positioning splint worn for 8 hours during night time for 3 months

Group Type ACTIVE_COMPARATOR

anterior re-positioning splint

Intervention Type DEVICE

hard acrylic anterior re-positioning splint

inactive laser therapy

placebo laser for 12 sessions over 3 months

Group Type PLACEBO_COMPARATOR

inactive Laser therapy

Intervention Type DEVICE

sham Laser, with inactive beam

Interventions

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Laser therapy

epic model biolase with an output of 4W, 1800 J wavelength with a continuous Laser mode.

Intervention Type DEVICE

anterior re-positioning splint

hard acrylic anterior re-positioning splint

Intervention Type DEVICE

inactive Laser therapy

sham Laser, with inactive beam

Intervention Type DEVICE

Other Intervention Names

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low-level Laser therapy Biolase laser device occlusal splint TMD splint

Eligibility Criteria

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Inclusion Criteria

1. Patients having TMD in the form of disc displacement with reduction as verified from signs and symptoms during clinical examination and confirmed from the MRI.
2. Good general health: The patient must be medically free from any systemic disease or health problems.
3. Adult patients 18 years old and above.
4. No previous orthodontic treatment.
5. No previous TMJ treatment or surgery.

Exclusion Criteria

1. Patients with multiple missing posterior teeth.
2. Muscle pain due to systemic disease.
3. Dental related pain.
4. Congenital abnormality, neoplasia or acute trauma.
5. Previous TMJ treatment or surgery.
6. Any medical condition that prohibits MRI acquisition.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Nada Elzawahry

assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mona S Fayed, PHD

Role: STUDY_DIRECTOR

Professor of Orthodontics, Faculty of Dentistry, Cairo Universitye

Other Identifiers

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CEBD-CU-2015-02-25

Identifier Type: -

Identifier Source: org_study_id

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