Clinical trial NCT05618795: " Comparative Evaluation of Aggressive Gap Arthroplasty With Minimal Gap Arthroplasty in the Management of TMJ Ankylosis "
Official title: " Comparative Evaluation of Aggressive Gap Arthroplasty With Minimal Gap Arthroplasty in the Management of TMJ Ankylosis "
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Arthoplasty
Keywords: Gap Arthoplasty
Lead sponsor: Postgraduate Institute of Dental Sciences Rohtak
Sponsor class: OTHER
First posted: 2022-11-16
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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) .

Eligibility criteria: 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

Primary outcomes:
measure: mouth opening
timeFrame: T0- preoperatively
measure: mouth opening
timeFrame: T1- 24hr after surgical intervention
measure: mouth opening
timeFrame: T2- 1 month after surgical intervention
measure: mouth opening
timeFrame: T3- 3 month after surgical intervention
measure: mouth opening
timeFrame: T4- 6 month after surgical intervention
Secondary outcomes:
measure: Protrusive movement
timeFrame: T0- preoperatively
measure: Protrusive movement
timeFrame: T1- 24hr after surgical intervention
measure: Protrusive movement
timeFrame: T2- 1 month after surgical intervention
measure: Protrusive movement
timeFrame: T3- 3 month after surgical intervention
measure: Protrusive movement
timeFrame: T4- 6 month after surgical intervention
measure: Laterotrusive movement
timeFrame: T0- preoperatively
measure: Laterotrusive movement
timeFrame: T1- 24hr after surgical intervention
measure: Laterotrusive movement
timeFrame: T2- 1 month after surgical intervention
measure: Laterotrusive movement
timeFrame: T3- 3 month after surgical intervention
measure: Laterotrusive movement
timeFrame: T4- 6 month after surgical intervention
measure: Any complication
timeFrame: T0- preoperatively
measure: Any complication
timeFrame: T1- 24hr after surgical intervention
measure: Any complication
timeFrame: T2- 1 month after surgical intervention
measure: Any complication
timeFrame: T3- 3 month after surgical intervention
measure: Any complication
timeFrame: T4- 6 month after surgical intervention
Other outcomes:
Locations:
city: Rohtak
country: India
facility: Pgids
state: Haryana
Study officials:
References: