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ArthoplastyNCT05618795

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

A study testing minimal gap arthoplasty v/s aggressive gap arthoplasty in people with Arthoplasty, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Arthoplasty
What is being tested?
minimal gap arthoplasty v/s aggressive gap arthoplasty
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteIndia
Study dates
1 Sep 2022to 30 Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Dr. Amrish Bhogal, MDS contact

9050421271

Bhagol.amrish@gmail.com

India1 site, 1 recruiting

  • Pgids

    Rohtak, Haryana, 124001

    Dr. Amrish Bhogal, MDS, 9050421271, Bhagol.amrish@gmail.com

    Recruiting

Other trials in India

About this study

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.

Read the 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) .
Conditions
Arthoplasty
Being tested
minimal gap arthoplasty v/s aggressive gap arthoplasty
Keywords
Gap Arthoplasty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • minimal gap arthoplasty v/s aggressive gap arthoplastyOther

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

Study groups in NCT05618795
Study groupRoleWhat they receive
aggresive gap arthoplastyOthercontrol group- aggressive gap arthroplasty(15 to 20 mm) for management of TMJ ankyosis
Receives: Other: minimal gap arthoplasty v/s aggressive gap arthoplasty
minimal gap arthoplastyActive comparatorexperimental group-minimal gap arthroplasty(5 to 8mm) for management of TMJ ankylosis
Receives: Other: minimal gap arthoplasty v/s aggressive gap arthoplasty

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. mouth opening

    maximal interincisal distance on opening mouth widely.

    Measured: T0- preoperatively

  2. mouth opening

    maximal interincisal distance on opening mouth widely.

    Measured: T1- 24hr after surgical intervention

  3. mouth opening

    maximal interincisal distance on opening mouth widely.

    Measured: T2- 1 month after surgical intervention

  4. mouth opening

    maximal interincisal distance on opening mouth widely.

    Measured: T3- 3 month after surgical intervention

  5. mouth opening

    maximal interincisal distance on opening mouth widely.

    Measured: T4- 6 month after surgical intervention

Secondary outcomes (15)

  1. Protrusive movement

    maximal protrusive movement on mandibular advancement

    Measured: T0- preoperatively

  2. Protrusive movement

    maximal protrusive movement on mandibular advancement

    Measured: T1- 24hr after surgical intervention

  3. Protrusive movement

    maximal protrusive movement on mandibular advancement

    Measured: T2- 1 month after surgical intervention

  4. Protrusive movement

    maximal protrusive movement on mandibular advancement

    Measured: T3- 3 month after surgical intervention

  5. Protrusive movement

    maximal protrusive movement on mandibular advancement

    Measured: T4- 6 month after surgical intervention

  6. Laterotrusive movement

    maximal lateral movement on mandibular excursion

    Measured: T0- preoperatively

  7. Laterotrusive movement

    maximal lateral movement on mandibular excursion

    Measured: T1- 24hr after surgical intervention

  8. Laterotrusive movement

    maximal lateral movement on mandibular excursion

    Measured: T2- 1 month after surgical intervention

  9. Laterotrusive movement

    maximal lateral movement on mandibular excursion

    Measured: T3- 3 month after surgical intervention

  10. Laterotrusive movement

    maximal lateral movement on mandibular excursion

    Measured: T4- 6 month after surgical intervention

  11. Any complication

    Any complication after surgery

    Measured: T0- preoperatively

  12. Any complication

    Any complication after surgery

    Measured: T1- 24hr after surgical intervention

  13. Any complication

    Any complication after surgery

    Measured: T2- 1 month after surgical intervention

  14. Any complication

    Any complication after surgery

    Measured: T3- 3 month after surgical intervention

  15. Any complication

    Any complication after surgery

    Measured: T4- 6 month after surgical intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Nov 2022
  2. Study start1 Sep 2022
  3. Primary completion1 Mar 2024 (estimated)
  4. Study completion30 Sep 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05618795
Sponsor's protocol ID
PGIDS/BHRC/22/41 NILESH BAGDE
Status last verified
Nov 2022
First submitted
8 Nov 2022
Last updated
16 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing minimal gap arthoplasty v/s aggressive gap arthoplasty in people with Arthoplasty, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Dr. Amrish Bhogal, MDS (9050421271, Bhagol.amrish@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

mouth opening (time frame: T0- preoperatively). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05618795.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2022.

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