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

Temporomandibular Joint Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03576079
• Other study ID #: CEBD-CU-2015-02-25
• Status: Completed
• Phase: N/A
• Start date: September 1, 2015
• Est. completion date: June 1, 2018

Study information

• Verified date: July 2018
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 1, 2018
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Joint Diseases
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Device:
• Laser therapy
epic model biolase with an output of 4W, 1800 J wavelength with a continuous Laser mode.
• anterior re-positioning splint
hard acrylic anterior re-positioning splint
• inactive Laser therapy
sham Laser, with inactive beam

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	click: joint sound	joint sound., it is a binary measurement assessed by hand palpation	3 months
Secondary	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
Secondary	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