Computed Guided Prolotherapy Versus Conventional Prolotherapy in Treatment of TMJ Internal Derangment
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Al-Azhar University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- The number of needle insertion attempts
Study Overview
Brief Summary
The aim of that study is to compare between conventional prolotherapy and computed guided prolotherapy in treatment of temporomandibular joint (TMJ) internal derangement.
Detailed Description
This study will include patients with TMJ internal derangement with signs and symptoms of pain, clicking and limited mouth opening .The study will be held in oral and maxillofacial department, Faculty of Dental Medicine, Al-Azhar University, Assiut branch. Internal derangement of the joint will be confirmed by magnetic resonance image (MRI).
Patients included in this study will be divided randomly into two equal groups by the aid of financial coins. Group I: patients will be conventionally injected into the superior space of TMJ by injectable PRF by the aid of the surface facial landmarks where the patient will seated comfortably at 45° angle on the dental chair with the head turned toward the unaffected side. The target site will be prepared and disinfected with betadine. The points of needle insertion will be marked on the skin according to a line will be draw from the middle of the tragus of the ear to the outer canthus of the eye and entry points will be marked along this cantho-tragal line which will correspond to the glenoid fossa and will be marked 10 mm from the mid-tragus and 2 mm below the line.
Group II: patients will be injected into the superior space of TMJ with I- PRF by the aid of specific CT-planned 3D-printed surgical guide, which will lead the needle insertion, and the accuracy of the needle insertion into the superior space of the TMJ will be assessed.
Preparation of I-PRF:
The cubital area of the patient arm will be disinfected with betadine and the blood will be drawn from the patient cubital vein into plain tubes (vaccutainers) under aseptic conditions .The loaded tubes will be centrifuged at 750 rpm for 3 minutes and the I-PRF will be aspirated into a plastic syringe to be ready for injection into the superior space of the TMJ of patients of each group.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Bilateral or unilateral TMJ internal derangement.
- •No response to conservative treatments (soft diet, occlusal splint, muscle relaxants, non-steroidal anti-inflammatory drugs, or movement restriction).
- •Ability to undergo MRI or CT scans without contraindications.
Exclusion Criteria
- •Those with systemic diseases (polyarthritis or rheumatoid diseases).
- •Individuals with neurologic disorders.
- •Patients with a history of condylar fracture or previous TMJ injections.
- •Those with head and neck cancer.
- •Completely edentulous patients (lacking teeth).
- •Individuals with implanted metal or medical devices.
- •Patients with developmental and congenital disorders of the TMJ.
Arms & Interventions
Group I; Conventional arthrocentesis followed by I-PRF injection
Patients received arthrocentesis followed by I-PRF injection, employing the conventional TMJ injection technique aided by facial anatomical landmarks
Intervention: Conventional arthrocentesis followed by I-PRF injection (Procedure)
Group II; 3d surgical guided Arthrocentesis followed by I-PRF injection
Patients received arthrocentesis followed by I-PRF injection with the assistance of a CT-guided 3D printed surgical guide.
Intervention: 3d surgical guided Arthrocentesis followed by I-PRF injection (Procedure)
Outcomes
Primary Outcomes
The number of needle insertion attempts
Time Frame: Intraoperative
The number of needle insertions, indicative of the attempts, was counted for each group.
Assessment of Pain
Time Frame: Intraoperative,1 week, 1month and 3 months
Using visual analog scale
Secondary Outcomes
- Time of operation(Intraoperative)
- Maximal incisal opening(1 week, 1month and 3 months)
Investigators
Zahran Arafat Ahmed Arafat
Demonstrator at the Department of oral and Maxillofacial Surgery
Al-Azhar University