Comparative Efficacy of Prolotherapy and Dry Needling in Management of Anterior Disc Displacement of Temporomandibular Joint
Trial Snapshot
- Phase
- Phase 4
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Maximal mouth opening
Study Overview
Brief Summary
Pain and trismus caused by Anterior disc displacement ADD of temporomandibular joint (TMJ) are one of the prime concerns for the patients. In the recent times, Inflammatory Prolotherapy has been studied extensively and has produced promising results. In Inflammatory prolotherapy low grade inflammation is induced physiologically by injection of an irritant solution that initiates healing cascade which leads to repair of the joint structures.
Thus, the Present study is designed to evaluate the efficacy of dextrose prolotherapy for the treatment of ADD in TMJ.
Detailed Description
Temporomandibular joint (TMJ) is a ginglymodiarthroidal joint located bilaterally in the preauricular region of head. It is formed by the confluence of multiple skeletal, muscular, ligament and discal components which work in harmony with each other. Articular disc functions as a non-ossified bone, allowing complex movements, making it a compound joint.
Any loss in synchronization or harmony of the components of TMJ leads to temporomandibular disorders. Okeson broadly classified temporomandibular disorders into Masticatory muscle disorders, Temporomandibular joint disorders. Disc displacements are categorized under Temporomandibular joint disorders of the condyle-disc complex.
Normally articular disc is positioned over the cranial portion of mandibular condyle at 12 o'clock position when teeth are in occlusion. Abnormal position of disc with respect to mandibular condyle or mandibular fossa is known as disc displacement. Most common displacement of disc is in antero-medial direction.1 Disc displacements are of two types: disc displacement with reduction and disc displacement without reduction. Anterior disc displacement (ADD) associated with pain require treatment.
Established treatment modalities include use of Non steroidal anti inflammatory drugs (NSAIDS), Anterior repositioning appliances, Physiotherapy, Psychological therapy, Arthroscopy, Arthroplasty and Arthrocentesis. Newer treatment modalities that are under research are platelet rich plasma therapy, prolotherapy and stem cell therapy.
Prolotherapy, which is also known as regenerative injection therapy, and growth factor stimulation injection therapy. It can be used to strengthen and repair chronic ligament, joint, capsule, and tendinous injuries by stimulating proliferation of collagen at the fibro osseous junctions to promote soft tissue repair and relative pain.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients diagnosed with Anterior disc displacement clinically according to TMD/RDC criteria (2013-14).
- •Patients diagnosed with Anterior disc displacement confirmed using Magnetic Resonance Imaging.
Exclusion Criteria
- •Patients with phobia to needles
- •Patients who have undergone previous treatment for anterior disc displacement in past 6 months
- •Patients who are allergic to the components of prolotherapy solution
- •Patients with active infection at the site of injection
- •Patients on anticoagulant medication
- •Patients with healing disorder or systemic disease where healing response is compromised
- •Patients with epilepsy/seizures
- •Patients with bleeding and clotting disorder
- •Patients with malignancy
- •Patients with uncontrolled para-functional habits
Outcomes
Primary Outcomes
Maximal mouth opening
Time Frame: 6 months
Manual measurement in mm
Intensity of pain
Time Frame: 6 months
VAS Score
Secondary Outcomes
- Joint sounds(6 months)
- Patient satisfaction(6 months)
- Assessment of Sleep pattern(6 months)
- Range of Protrusive movement(6 months)
- Range of Right and left Lateral excursion movements(6 months)
- Pain medicine utilization(6 months)