A randomized control trial comparing the efficacy of joint lavage ,mandibular manipulation and anterior repositioning splint versus joint lavage and mandibular manipulation in management of temporomandibular disc displacement without reduction

Phase 2/3

Not yet recruiting

• Conditions: ASA 1 PATIENTS WITH TMD PROBLEM WILKES CLASSIFICATION 3; Temporomandibular joint disorders,

• Registration Number: CTRI/2020/12/029524
• Lead Sponsor: Division of oral and maxillofacial surgery

Brief Summary

A randomized clinical trial comparing the efficacy of arthrocentesis with mandibular manipulation and anterior repositioning splint versus arthrocentesis and mandibular manipulation in the management of temporomandibular joint disc displacement without reduction

PRIMARY OBJECTIVE To compare efficiency of arthrocentesis, mandibular manipulation and anterior repositioning splint therapy versus that of arthrocentesis and mandibular manipulation in Wilkes stage 3 temporomandibular disorders (TMDs) for management of pain after procedure by using VAS score.

SECONDARY OBJECTIVES To compare the two procedures for the following:

• To assess the change in disc condyle angle and condyle disc position (MRI Evaluation) at 3 months follow up

• To measure mouth opening (passive and assisted) at 2 weeks ,1 month, 3 months and 6 months follow up.

• To access the subjective chewing efficacy 2 weeks, 1month, 3 months and 6 months follow up.

• To assess the clicking after 2 weeks, 1 month, 3 months and 6 months follow up.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-11-19
• Study Start: 2020-12-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

ASA I patients • Wilkes class III – Anterior disc displacement without reduction as confirmed by MRI • Patient willing for informed consent and follow up.

Exclusion Criteria

Prior surgical treatment for TMD • Edentulous patients • Age<15years • Presence of occlusion conditions (anterior cross bite) • Presence of TMJ pathology • Any medical condition which contraindicate the mentioned intervention • Patient ongoing chemo or radiotherapy • Pregnant patient • Patient not willing for informed consent and not coming for follow up.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare efficiency of arthrocentesis, mandibular manipulation and anterior	Pre intervention | 2 weeks ,1 mnonth, 3 months and 6 months after intervention
repositioning splint therapy versus that of arthrocentesis and mandibular manipulation in	Pre intervention | 2 weeks ,1 mnonth, 3 months and 6 months after intervention
Wilkes stage 3 temporomandibular disorders (TMDs) for management of pain after	Pre intervention | 2 weeks ,1 mnonth, 3 months and 6 months after intervention
procedure by using VAS score.	Pre intervention | 2 weeks ,1 mnonth, 3 months and 6 months after intervention

Secondary Outcome Measures

Name	Time	Method
To assess the change in disc condyle angle and condyle disc position (MRI	Evaluation) at 3 months follow up

Trial Locations

Locations (1)

DEPT OF ORAL AND MAXILLOFACIAL SURGERY; 🇮🇳 Delhi, DELHI, India

DEPT OF ORAL AND MAXILLOFACIAL SURGERY

🇮🇳Delhi, DELHI, India

DR ANUVINDHA J S

Principal investigator

8590076580

anuomfs1994@gmail.com