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

Study Overview
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Brief Summary
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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.

Detailed Description
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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. All the patients were evaluated with history, clinical and radiological examinations (panoramic and CT scans). Informed consent will be obtaine from all the patients. 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) .

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

Conditions
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Arthoplasty

Intervention / Treatment
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* Other: minimal gap arthoplasty v/s aggressive gap arthoplasty


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gap Arthoplasty