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
1 other identifier
interventional
30
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2015
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedFirst Submitted
Initial submission to the registry
June 9, 2018
CompletedFirst Posted
Study publicly available on registry
July 3, 2018
CompletedJuly 3, 2018
July 1, 2018
2.1 years
June 9, 2018
July 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
click: joint sound
3 months
limitation of mandibular movements
3 months
disc recapture
3 months
Study Arms (3)
Laser therapy
EXPERIMENTAL12 laser sessions over 3 months
anterior re-positioning splint therapy
ACTIVE COMPARATORanterior re-positioning splint worn for 8 hours during night time for 3 months
inactive laser therapy
PLACEBO COMPARATORplacebo laser for 12 sessions over 3 months
Interventions
epic model biolase with an output of 4W, 1800 J wavelength with a continuous Laser mode.
hard acrylic anterior re-positioning splint
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mona S Fayed, PHD
Professor of Orthodontics, Faculty of Dentistry, Cairo Universitye
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant lecturer
Study Record Dates
First Submitted
June 9, 2018
First Posted
July 3, 2018
Study Start
September 1, 2015
Primary Completion
September 30, 2017
Study Completion
June 1, 2018
Last Updated
July 3, 2018
Record last verified: 2018-07