Comparision of blood product and polymer solution included blood product for the treatment of jaw joint problem.

Not yet recruiting

Conditions: Other specific joint derangements,not elsewhere classified,

Registration Number: CTRI/2023/11/059991

Lead Sponsor: Malya Manoj Kumar Naik

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 28

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Pain at rest & chewing, assessed by means of a visual analog scale.	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.	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.	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.	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.	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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1): Vishnu Dental College
🇮🇳
Godavari, ANDHRA PRADESH, India
Vishnu Dental College
🇮🇳Godavari, ANDHRA PRADESH, India
Dr Malya Manoj Kumar Naik
Principal investigator
9490734248
mimanojkumar21@gmail.com