" Comparative Evaluation of Aggressive Gap Arthroplasty With Minimal Gap Arthroplasty in the Management of TMJ Ankylosis "

the most commonly used protocol in the management of TMJ ankylosis is Kabans protocol in which 1.5 to 2 cm aggressive resection of bone is recommended which may lead to gap between cranial base and condyle of mandible.1 However, there are certain disadvantages associated with aggressive gap arthroplasty such as pseudo articulation with shortening of the mandibular ramus, premature occlusion on the affected side with a contralateral open bite in unilateral cases,2 in bilateral cases gagging of the posterior teeth and anterior open bite.3 Few studies in the literature available agreed that minimum gap arthroplasty i.e. 5 to 8 mm of gap is sufficient for TMJ movements in all planes and recurrence of ankylosis is likely to be prevented by interposed material (graft)4 .So, a randomized control study to compare outcomes of minimal gap arthroplasty with aggressive gap arthroplasty for management of TMJ ankylosis is planned.

Study Overview

• Status: Recruiting
• Conditions: Arthoplasty
• Intervention / Treatment: Other: minimal gap arthoplasty v/s aggressive gap arthoplasty

Detailed Description

A standardize protocol for each patient will be followed that comprises of case selection, clinincal evaluation, radiographic assessment,treatment planning and measurement of varius parameters.

• Medical and Dental history of the patient will be obtained.
• A written consent form signed by the patient, will be obtained.

• Case evaluation will be done which will include clinical and radiographic evaluation Based on the case evaluation, surgical treatment of ankylosis will be performed . patient will be randomized into the following two groups. Group A -minimal gap arthroplasty for management of Tmj ankylosis Group B -aggressive gap arthroplasty for management of TMJ ankylosis A minimum of 6 subjects per group completing the study would be giving a good external validity to the present study.

  1. All the patients were evaluated with history, clinical and radiological examinations (panoramic and CT scans). Informed consent will be obtaine from all the patients.
  2. In both groups, all the patients will be operated by an experienced surgeon.The data acquisition will be done by a resident who will be kept blind for group allocation.

  3. In group 1 cases treatment of TMJ ankylosis will be done by minimal gap arthroplasty and in group 2 cases treatment of TMJ ankylosis will be done by aggressive gap arthroplasty 4. both groups cases will be evaluated preoperatively ,intraoperatively and postoperatively Follow-up visits will be at 1, 3, and 6 months 5. preoperative and postoperative evaluation will be done clinically ( mouth opening ,protrusive movement, laterotrusive movement ) , radiologically (OPG, CTscan) .

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr. Amrish Bhogal, MDS; Phone Number: 9050421271; Email: Bhagol.amrish@gmail.com

Study Locations

• India
  • Haryana
    • Rohtak, Haryana, India, 124001
      • Recruiting
      • PGIDS
      • Contact: Dr. Amrish Bhogal, MDS; Phone Number: 9050421271; Email: Bhagol.amrish@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Medically healthy adult(ASA Classification I-II)
• Any age group
• Sawhneys classification type IV
• Unilateral ankylosis
• Written informed consent

Exclusion Criteria:

• Any syndromic patient
• Recurrence cases
• Sawhneys classification type I,II,III

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: aggresive gap arthoplasty; control group- aggressive gap arthroplasty(15 to 20 mm) for management of TMJ ankyosis	Other: minimal gap arthoplasty v/s aggressive gap arthoplasty; Comparative evaluation of aggressive gap arthroplasty with minimal gap arthroplasty in the management of TMJ ankylosis
Active Comparator: minimal gap arthoplasty; experimental group-minimal gap arthroplasty(5 to 8mm) for management of TMJ ankylosis	Other: minimal gap arthoplasty v/s aggressive gap arthoplasty; Comparative evaluation of aggressive gap arthroplasty with minimal gap arthroplasty in the management of TMJ ankylosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mouth opening	maximal interincisal distance on opening mouth widely.	T0- preoperatively
mouth opening	maximal interincisal distance on opening mouth widely.	T1- 24hr after surgical intervention
mouth opening	maximal interincisal distance on opening mouth widely.	T2- 1 month after surgical intervention
mouth opening	maximal interincisal distance on opening mouth widely.	T3- 3 month after surgical intervention
mouth opening	maximal interincisal distance on opening mouth widely.	T4- 6 month after surgical intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Protrusive movement	maximal protrusive movement on mandibular advancement	T0- preoperatively
Protrusive movement	maximal protrusive movement on mandibular advancement	T1- 24hr after surgical intervention
Protrusive movement	maximal protrusive movement on mandibular advancement	T2- 1 month after surgical intervention
Protrusive movement	maximal protrusive movement on mandibular advancement	T3- 3 month after surgical intervention
Protrusive movement	maximal protrusive movement on mandibular advancement	T4- 6 month after surgical intervention
Laterotrusive movement	maximal lateral movement on mandibular excursion	T0- preoperatively
Laterotrusive movement	maximal lateral movement on mandibular excursion	T1- 24hr after surgical intervention
Laterotrusive movement	maximal lateral movement on mandibular excursion	T2- 1 month after surgical intervention
Laterotrusive movement	maximal lateral movement on mandibular excursion	T3- 3 month after surgical intervention
Laterotrusive movement	maximal lateral movement on mandibular excursion	T4- 6 month after surgical intervention
Any complication	Any complication after surgery	T0- preoperatively
Any complication	Any complication after surgery	T1- 24hr after surgical intervention
Any complication	Any complication after surgery	T2- 1 month after surgical intervention
Any complication	Any complication after surgery	T3- 3 month after surgical intervention
Any complication	Any complication after surgery	T4- 6 month after surgical intervention

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Dental Sciences Rohtak

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Anticipated): March 1, 2024
• Study Completion (Anticipated): September 30, 2024

Study Registration Dates

• First Submitted: November 8, 2022
• First Submitted That Met QC Criteria: November 8, 2022
• First Posted (Actual): November 16, 2022

Study Record Updates

• Last Update Posted (Actual): November 16, 2022
• Last Update Submitted That Met QC Criteria: November 8, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Gap Arthoplasty
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Ankylosis
• Other Study ID Numbers: PGIDS/BHRC/22/41 NILESH BAGDE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No