Comparison of Injectable Platelet-Rich Fibrin and Hyaluronic Acid Combination versus Injectable Platelet-Rich Fibrin Only in Internal Derangement Of Temporomandibular Joint: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- 1.Pain at rest & chewing, assessed by means of a visual analog scale.
Study Overview
Brief Summary
The aim of the study is to investigate the efficacy of combination of Hyaluronic acid, I-PRF and I-PRF alone in patients with internal derangements of the temporomandibular joint (TMJ).A total of 28 patients with tmj internal derangement will be selected from outpatient department of oral and maxillofacial surgery,vishnu dental college,bhimavaram, and will be equally divided into 2 groups of 14 each.in group-A arthrocentesis followed by i-prf injection and in group-B arthrocentesis followed by i-prf and hyaluronic acid combination.The study is interventional prospective study.computer generated randomization will be used as sampling method.The following primary outcomes
a) Pain at rest and chewing
b) Mandibular range of movement
c) Clicking
d) QOL questionnaire
d)functional limitation
will be measured at preoperative,1 week,1 month,3 months,6 months.
The data will be analyzed individually for all the patients.There is no conflict of interest.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Patients in the age group of 18-60 years.
- •2.Patients diagnosed with Wilkes stage II and III of ID of temporomandibular joint.
- •3.Patients not responding to conservative treatments.
- •4.Willingness to participate in the study and to give informed consent.
- •5.Willing for a minimum 6-month follow-up after undergoing treatment.
Exclusion Criteria
- •1.Any systemic or malignant disease that could interfere with the TMJ treatment or assessment.
- •2.History of Previous TMJ surgery/condylar trauma.
- •3.Failure during intra-articular injection procedure.
- •4.Fibrous or osseous ankylosis of the TMJ.
- •5.Cutaneous, otic, or articular infections.
- •6.Edentulous patients.
- •7.Pregnant and breastfeeding.
- •8.Bilateral TMJ pain.
Outcomes
Primary Outcomes
1.Pain at rest & chewing, assessed by means of a visual analog scale.
Time Frame: 1.Pain at rest & chewing at 1 Week,1 month,3 months,6 months postoperative. | 2.Mandibular range of movement, comprising maximum non assisted & assisted mouth opening, left & right laterotrusion, & protrusion movements at 1 Week,1 month,3 months,6 months postoperative. | 3.Clicking at 1 Week,1 month,3 months,6 months postoperative. | 4.QOL questionnaire at 1 Week,1 month,3 months,6 months postoperative. | 5.Functional limitation at 1 Week,1 month,3 months,6 months postoperative.
2.Mandibular range of movement, comprising maximum non assisted & assisted mouth opening, left & right laterotrusion, & protrusion movements.
Time Frame: 1.Pain at rest & chewing at 1 Week,1 month,3 months,6 months postoperative. | 2.Mandibular range of movement, comprising maximum non assisted & assisted mouth opening, left & right laterotrusion, & protrusion movements at 1 Week,1 month,3 months,6 months postoperative. | 3.Clicking at 1 Week,1 month,3 months,6 months postoperative. | 4.QOL questionnaire at 1 Week,1 month,3 months,6 months postoperative. | 5.Functional limitation at 1 Week,1 month,3 months,6 months postoperative.
5.Functional limitation during usual jaw movements.
Time Frame: 1.Pain at rest & chewing at 1 Week,1 month,3 months,6 months postoperative. | 2.Mandibular range of movement, comprising maximum non assisted & assisted mouth opening, left & right laterotrusion, & protrusion movements at 1 Week,1 month,3 months,6 months postoperative. | 3.Clicking at 1 Week,1 month,3 months,6 months postoperative. | 4.QOL questionnaire at 1 Week,1 month,3 months,6 months postoperative. | 5.Functional limitation at 1 Week,1 month,3 months,6 months postoperative.
3.Clicking by Auscultation.
Time Frame: 1.Pain at rest & chewing at 1 Week,1 month,3 months,6 months postoperative. | 2.Mandibular range of movement, comprising maximum non assisted & assisted mouth opening, left & right laterotrusion, & protrusion movements at 1 Week,1 month,3 months,6 months postoperative. | 3.Clicking at 1 Week,1 month,3 months,6 months postoperative. | 4.QOL questionnaire at 1 Week,1 month,3 months,6 months postoperative. | 5.Functional limitation at 1 Week,1 month,3 months,6 months postoperative.
4.QOL questionnaire.
Time Frame: 1.Pain at rest & chewing at 1 Week,1 month,3 months,6 months postoperative. | 2.Mandibular range of movement, comprising maximum non assisted & assisted mouth opening, left & right laterotrusion, & protrusion movements at 1 Week,1 month,3 months,6 months postoperative. | 3.Clicking at 1 Week,1 month,3 months,6 months postoperative. | 4.QOL questionnaire at 1 Week,1 month,3 months,6 months postoperative. | 5.Functional limitation at 1 Week,1 month,3 months,6 months postoperative.
Secondary Outcomes
- 1.Pain at rest & chewing, assessed by means of a visual analog scale.(2.Mandibular range of movement, comprising maximum non assisted & assisted mouth opening, left & right laterotrusion, & protrusion movements.)