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

Effect of Laser Irradiation Versus Anterior Repositioning Splint in Treatment of Disc Displacement With Reduction A Randomized Controlled Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Temporomandibular Joint Disorders
• Intervention / Treatment: Device: Laser therapy; Device: anterior re-positioning splint; Device: inactive Laser therapy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laser therapy; 12 laser sessions over 3 months	Device: Laser therapy; epic model biolase with an output of 4W, 1800 J wavelength with a continuous Laser mode.; Other Names: low-level Laser therapy; Biolase laser device
Active Comparator: anterior re-positioning splint therapy; anterior re-positioning splint worn for 8 hours during night time for 3 months	Device: anterior re-positioning splint; hard acrylic anterior re-positioning splint; Other Names: occlusal splint; TMD splint
Placebo Comparator: inactive laser therapy; placebo laser for 12 sessions over 3 months	Device: inactive Laser therapy; sham Laser, with inactive beam

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of temporomandibular joint pain: assessed by using subjective visual analogue scale	current level of temporomandibular joint pain assessed by using subjective visual analogue scale from 1 to 10 according to the research diagnostic criteria of temporomandibular disorders diagnostic sheets, zero indicates no pain, while 10 indicates the worst pain	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
click: joint sound	joint sound., it is a binary measurement assessed by hand palpation	3 months
limitation of mandibular movements	mouth opening, measured between the incisal edges of upper and lower incisors using a digital caliper, right and left mandibular movements, measured from upper dental midline to lower dental midline using a digital caliper.	3 months
disc recapture	change in articular disc morphology and configuration using two dimensional measurements on a DICOM viewer software including both linear and angular measurements in relation to cartesian coordinates X and Y	3 months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Mona S Fayed, PHD, Professor of Orthodontics, Faculty of Dentistry, Cairo Universitye

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): September 30, 2017
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: June 9, 2018
• First Submitted That Met QC Criteria: July 2, 2018
• First Posted (Actual): July 3, 2018

Study Record Updates

• Last Update Posted (Actual): July 3, 2018
• Last Update Submitted That Met QC Criteria: July 2, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: laser therapy; anterior re-positioning splint
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Muscular Diseases; Stomatognathic Diseases; Jaw Diseases; Craniomandibular Disorders; Mandibular Diseases; Myofascial Pain Syndromes; Joint Diseases; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Anti-Infective Agents; Dermatologic Agents; Antifungal Agents; Keratolytic Agents; Salicylic Acid
• Other Study ID Numbers: CEBD-CU-2015-02-25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes