Clinical trial
Evolving Treatment Modalities for Management of Patients Suffering From Disc Displacement With Reduction (A Randomized Clinical Trial)
Name
IRB 00010556
Description
Aim of the current study is to compare the efficacy of Low Level Laser, Botulinum toxin type A, and repositioning appliance in management of reduced temporomandibular joint disc.
Trial arms
Trial start
2022-01-10
Estimated PCD
2022-05-20
Trial end
2022-06-01
Status
Completed
Treatment
Low level laser therapy
Patients will receive low-level laser therapy on the temporomandibular joint disc
Arms:
Low level laser therapy
Other names:
LLLT
Botulinum toxin type A
Patients will receive Botulinum toxin type A injection into the lateral pterygoid muscle under Electromyography (EMG) guidance.
Arms:
Botulinum toxin type A
Other names:
Botox
Anterior repositioning appliance
Patients will receive hard maxillary anterior repositioning appliance.
Arms:
Anterior repositioning appliance
Size
27
Primary endpoint
Temporomandibular joint dysfunction
3 months
Pain level
3 months
Temporomandibular joint clinical evaluation
3 months
Eligibility criteria
Inclusion Criteria:
* TMJ with audible and palpable click.
* Patients with anterior disc displacement as detected by MRI.
* Presence of full or nearly full complement of natural teeth.
Exclusion Criteria:
* Patients who have radiographic evidence of degenerative conditions of TMJ.
* Patients who have anterior disc dislocation without reduction.
* Previous history of TMD treatment.
* History of recent trauma.
* The presence of systemic diseases (i.e. rheumatoid arthritis, osteoarthritis).
* Inability or unwillingness to undergo magnetic resonance imaging (MRI) such as implanted electronic devices.
* Pregnant and lactating females.
* Patients with known allergy to botulinum toxin type A.
* Patients suffering from neurological disorders.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 27, 'type': 'ACTUAL'}}
Updated at
2023-12-04
1 organization
1 product
2 indications
Organization
Nourhan M. AlyProduct
Botulinum toxin type AIndication
With Reduction