Back to resultsEffect of Laser Therapy Versus Anterior Re-positioning Splint in the Treatment of Disc Displacement With Reduction
Primary Purpose
Temporomandibular Joint Disorders
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Laser therapy
anterior re-positioning splint
inactive Laser therapy
Sponsored by
About this trial
This is an interventional treatment trial for Temporomandibular Joint Disorders focused on measuring laser therapy, anterior re-positioning splint
Eligibility Criteria
Inclusion Criteria:
- 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.
- Good general health: The patient must be medically free from any systemic disease or health problems.
- Adult patients 18 years old and above.
- No previous orthodontic treatment.
- No previous TMJ treatment or surgery.
Exclusion Criteria:
- Patients with multiple missing posterior teeth.
- Muscle pain due to systemic disease.
- Dental related pain.
- Congenital abnormality, neoplasia or acute trauma.
- Previous TMJ treatment or surgery.
- Any medical condition that prohibits MRI acquisition.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Laser therapy
anterior re-positioning splint therapy
inactive laser therapy
Arm Description
12 laser sessions over 3 months
anterior re-positioning splint worn for 8 hours during night time for 3 months
placebo laser for 12 sessions over 3 months
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
click: joint sound
joint sound., it is a binary measurement assessed by hand palpation
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.
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03576079
Brief Title
Effect of Laser Therapy Versus Anterior Re-positioning Splint in the Treatment of Disc Displacement With Reduction
Official Title
Effect of Laser Irradiation Versus Anterior Repositioning Splint in Treatment of Disc Displacement With Reduction A Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
September 1, 2015 (Actual)
Primary Completion Date
September 30, 2017 (Actual)
Study Completion Date
June 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Joint Disorders
Keywords
laser therapy, anterior re-positioning splint
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Laser therapy
Arm Type
Experimental
Arm Description
12 laser sessions over 3 months
Arm Title
anterior re-positioning splint therapy
Arm Type
Active Comparator
Arm Description
anterior re-positioning splint worn for 8 hours during night time for 3 months
Arm Title
inactive laser therapy
Arm Type
Placebo Comparator
Arm Description
placebo laser for 12 sessions over 3 months
Intervention Type
Device
Intervention Name(s)
Laser therapy
Other Intervention Name(s)
low-level Laser therapy, Biolase laser device
Intervention Description
epic model biolase with an output of 4W, 1800 J wavelength with a continuous Laser mode.
Intervention Type
Device
Intervention Name(s)
anterior re-positioning splint
Other Intervention Name(s)
occlusal splint, TMD splint
Intervention Description
hard acrylic anterior re-positioning splint
Intervention Type
Device
Intervention Name(s)
inactive Laser therapy
Intervention Description
sham Laser, with inactive beam
Primary Outcome Measure Information:
Title
Level of temporomandibular joint pain: assessed by using subjective visual analogue scale
Description
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
Time Frame
3 months
Secondary Outcome Measure Information:
Title
click: joint sound
Description
joint sound., it is a binary measurement assessed by hand palpation
Time Frame
3 months
Title
limitation of mandibular movements
Description
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.
Time Frame
3 months
Title
disc recapture
Description
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
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Good general health: The patient must be medically free from any systemic disease or health problems.
Adult patients 18 years old and above.
No previous orthodontic treatment.
No previous TMJ treatment or surgery.
Exclusion Criteria:
Patients with multiple missing posterior teeth.
Muscle pain due to systemic disease.
Dental related pain.
Congenital abnormality, neoplasia or acute trauma.
Previous TMJ treatment or surgery.
Any medical condition that prohibits MRI acquisition.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mona S Fayed, PHD
Organizational Affiliation
Professor of Orthodontics, Faculty of Dentistry, Cairo Universitye
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effect of Laser Therapy Versus Anterior Re-positioning Splint in the Treatment of Disc Displacement With Reduction
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