" Comparative Evaluation of Aggressive Gap Arthroplasty With Minimal Gap Arthroplasty in the Management of TMJ Ankylosis "
Primary Purpose
Arthoplasty
Status
Recruiting
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
minimal gap arthoplasty v/s aggressive gap arthoplasty
Sponsored by
About this trial
This is an interventional treatment trial for Arthoplasty focused on measuring Gap Arthoplasty
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
Sites / Locations
- PgidsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Active Comparator
Arm Label
aggresive gap arthoplasty
minimal gap arthoplasty
Arm Description
control group- aggressive gap arthroplasty(15 to 20 mm) for management of TMJ ankyosis
experimental group-minimal gap arthroplasty(5 to 8mm) for management of TMJ ankylosis
Outcomes
Primary Outcome Measures
mouth opening
maximal interincisal distance on opening mouth widely.
mouth opening
maximal interincisal distance on opening mouth widely.
mouth opening
maximal interincisal distance on opening mouth widely.
mouth opening
maximal interincisal distance on opening mouth widely.
mouth opening
maximal interincisal distance on opening mouth widely.
Secondary Outcome Measures
Protrusive movement
maximal protrusive movement on mandibular advancement
Protrusive movement
maximal protrusive movement on mandibular advancement
Protrusive movement
maximal protrusive movement on mandibular advancement
Protrusive movement
maximal protrusive movement on mandibular advancement
Protrusive movement
maximal protrusive movement on mandibular advancement
Laterotrusive movement
maximal lateral movement on mandibular excursion
Laterotrusive movement
maximal lateral movement on mandibular excursion
Laterotrusive movement
maximal lateral movement on mandibular excursion
Laterotrusive movement
maximal lateral movement on mandibular excursion
Laterotrusive movement
maximal lateral movement on mandibular excursion
Any complication
Any complication after surgery
Any complication
Any complication after surgery
Any complication
Any complication after surgery
Any complication
Any complication after surgery
Any complication
Any complication after surgery
Full Information
NCT ID
NCT05618795
First Posted
November 8, 2022
Last Updated
November 8, 2022
Sponsor
Postgraduate Institute of Dental Sciences Rohtak
1. Study Identification
Unique Protocol Identification Number
NCT05618795
Brief Title
" 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
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Postgraduate Institute of Dental Sciences Rohtak
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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) .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthoplasty
Keywords
Gap Arthoplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
aggresive gap arthoplasty
Arm Type
Other
Arm Description
control group- aggressive gap arthroplasty(15 to 20 mm) for management of TMJ ankyosis
Arm Title
minimal gap arthoplasty
Arm Type
Active Comparator
Arm Description
experimental group-minimal gap arthroplasty(5 to 8mm) for management of TMJ ankylosis
Intervention Type
Other
Intervention Name(s)
minimal gap arthoplasty v/s aggressive gap arthoplasty
Intervention Description
Comparative evaluation of aggressive gap arthroplasty with minimal gap arthroplasty in the management of TMJ ankylosis
Primary Outcome Measure Information:
Title
mouth opening
Description
maximal interincisal distance on opening mouth widely.
Time Frame
T0- preoperatively
Title
mouth opening
Description
maximal interincisal distance on opening mouth widely.
Time Frame
T1- 24hr after surgical intervention
Title
mouth opening
Description
maximal interincisal distance on opening mouth widely.
Time Frame
T2- 1 month after surgical intervention
Title
mouth opening
Description
maximal interincisal distance on opening mouth widely.
Time Frame
T3- 3 month after surgical intervention
Title
mouth opening
Description
maximal interincisal distance on opening mouth widely.
Time Frame
T4- 6 month after surgical intervention
Secondary Outcome Measure Information:
Title
Protrusive movement
Description
maximal protrusive movement on mandibular advancement
Time Frame
T0- preoperatively
Title
Protrusive movement
Description
maximal protrusive movement on mandibular advancement
Time Frame
T1- 24hr after surgical intervention
Title
Protrusive movement
Description
maximal protrusive movement on mandibular advancement
Time Frame
T2- 1 month after surgical intervention
Title
Protrusive movement
Description
maximal protrusive movement on mandibular advancement
Time Frame
T3- 3 month after surgical intervention
Title
Protrusive movement
Description
maximal protrusive movement on mandibular advancement
Time Frame
T4- 6 month after surgical intervention
Title
Laterotrusive movement
Description
maximal lateral movement on mandibular excursion
Time Frame
T0- preoperatively
Title
Laterotrusive movement
Description
maximal lateral movement on mandibular excursion
Time Frame
T1- 24hr after surgical intervention
Title
Laterotrusive movement
Description
maximal lateral movement on mandibular excursion
Time Frame
T2- 1 month after surgical intervention
Title
Laterotrusive movement
Description
maximal lateral movement on mandibular excursion
Time Frame
T3- 3 month after surgical intervention
Title
Laterotrusive movement
Description
maximal lateral movement on mandibular excursion
Time Frame
T4- 6 month after surgical intervention
Title
Any complication
Description
Any complication after surgery
Time Frame
T0- preoperatively
Title
Any complication
Description
Any complication after surgery
Time Frame
T1- 24hr after surgical intervention
Title
Any complication
Description
Any complication after surgery
Time Frame
T2- 1 month after surgical intervention
Title
Any complication
Description
Any complication after surgery
Time Frame
T3- 3 month after surgical intervention
Title
Any complication
Description
Any complication after surgery
Time Frame
T4- 6 month after surgical intervention
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr. Amrish Bhogal, MDS
Phone
9050421271
Email
Bhagol.amrish@gmail.com
Facility Information:
Facility Name
Pgids
City
Rohtak
State/Province
Haryana
ZIP/Postal Code
124001
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Amrish Bhogal, MDS
Phone
9050421271
Email
Bhagol.amrish@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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" Comparative Evaluation of Aggressive Gap Arthroplasty With Minimal Gap Arthroplasty in the Management of TMJ Ankylosis "
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