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

NCT05618795 | Unknown

• 1 other identifier: PGIDS/BHRC/22/41 NILESH BAGDE
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthoplasty

Keywords

Gap Arthoplasty

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (15)

• Protrusive movement

  T0- preoperatively

• Protrusive movement

  T1- 24hr after surgical intervention

• Protrusive movement

  T2- 1 month after surgical intervention

• Protrusive movement

  T3- 3 month after surgical intervention

• Protrusive movement

  T4- 6 month after surgical intervention

Study Arms (2)

aggresive gap arthoplasty

OTHER

control group- aggressive gap arthroplasty(15 to 20 mm) for management of TMJ ankyosis

Other: minimal gap arthoplasty v/s aggressive gap arthoplasty

minimal gap arthoplasty

ACTIVE COMPARATOR

experimental group-minimal gap arthroplasty(5 to 8mm) for management of TMJ ankylosis

Other: minimal gap arthoplasty v/s aggressive gap arthoplasty

Interventions

minimal gap arthoplasty v/s aggressive gap arthoplasty OTHER

Comparative evaluation of aggressive gap arthroplasty with minimal gap arthroplasty in the management of TMJ ankylosis

aggresive gap arthoplasty; minimal gap arthoplasty

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

Pgids

Rohtak, Haryana, 124001, India

RECRUITING

Central Study Contacts

Dr. Amrish Bhogal, MDS

CONTACT

9050421271; Bhagol.amrish@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2022
• First Posted: November 16, 2022
• Study Start: September 1, 2022
• Primary Completion: March 1, 2024
• Study Completion: September 30, 2024
• Last Updated: November 16, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)