| CTRI Number |
CTRI/2026/04/108819 [Registered on: 20/04/2026] Trial Registered Prospectively |
| Last Modified On: |
20/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative evaluation of conventional vs modified osteotomy cut in surgical management of tmj ankylosis patient. |
|
Scientific Title of Study
|
Comparative evaluation of efficacy of conventional vs modified osteotomy cut in surgical management of temporomandibular joint ankylosis patients-A randomised Control trial. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. ROSHNI KUMARI |
| Designation |
RESIDENT |
| Affiliation |
Ziauddin Ahmad dental college,aligarh muslim university |
| Address |
Department of oral and maxillofacial surgery ,Ziauddin Ahmad Dental college
Aligarh Muslim University,Aligarh
Pincode :202002
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
6200769901 |
| Fax |
|
| Email |
Roshnik6194@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.ROSHNI KUMARI |
| Designation |
RESIDENT |
| Affiliation |
Ziauddin Ahmad dental college,aligarh muslim university |
| Address |
Department of oral and maxillofacial surgery ,Ziauddin Ahmad Dental college
Aligarh Muslim University
Pincode :202002
Department of oral and maxillofacial surgery ,ziauddin Ahmad dental college,Aligarh muslim university ,Aligarh . Pincode :202002
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
6200769901 |
| Fax |
|
| Email |
Roshnik6194@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.ROSHNI KUMARI |
| Designation |
RESIDENT |
| Affiliation |
Ziauddin Ahmad dental college,aligarh muslim university |
| Address |
Department of oral and maxillofacial surgery ,Ziauddin Ahmad Dental college
Aligarh Muslim University
Pincode :202002
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
6200769901 |
| Fax |
|
| Email |
Roshnik6194@gmail.com |
|
|
Source of Monetary or Material Support
|
| ZIAUDDIN AHMAD DENTAL COLLEGE,ALIGARH MUSLIM UNIVERSITY ,Aligarh ,uttarpradesh ,India .pincode 202002 |
|
|
Primary Sponsor
|
| Name |
ziauddin Ahmad Dental college |
| Address |
Ziauddin Ahmad Dental College
Aligarh Muslim university
Pincode :202002 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Roshni kumari |
Ziauddin Ahmad dental college ,amu |
Department of oral ad maxilliofacial surgery ,Ziauddin ahmad dental college Aligarh muslim university ,Aligarh.pincode-202002
Aligarh
UTTAR PRADESH |
6200769901
roshnik6194@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee(Regd.),jawaharlal nehru medical college and hospital,faculty of medicine ,Aligarh muslim university |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Gap arthroplasty with modified osteotomy cut. |
The inferior osteotomy cut is made parallel and 1–1.5 cm below in the anterior two-thirds, while the posterior one-third is directed inferiorly and divergent to maintain a 4–5 mm gap between bony surfaces. |
| Comparator Agent |
Graft volume |
Graft volume in conventional osteotomy cut versus modified osteotomy cutat 1week and 6 month postoperative. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patient with true osseous or fibroosseous intracapsular tmj ankylosis confirmed via ct |
|
| ExclusionCriteria |
| Details |
1)Recurrent tmj ankylosis cases
2)Patient with extra-articular fibrosis,pathological or mechan8cal obstruction
3)children below 6 year of age |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Rate of reankylosis in tmj ankylosis patient with conventional osteotomy cut versus modified osteotomy cut by comparing graft volumes on ct. |
Rate of reankylosis in tmj ankylosis patient with conventional osteotomy cut versus modified osteotomy cut by comparing graft volumes on ct postoperative after 6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of Pain on Visual analogue scalewhile physiotherapy |
At day 1,day 7 ,day 15 ,1month,3month,6month. |
| Comparison of Mouth opening in both groups |
Preoperative ,intraoperative ,postoprative at 1 week ,postoperative 6 month. |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
20/08/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - NIL
- For how long will this data be available start date provided 01-05-2028 and end date provided 01-04-2040?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
It is a study based on Comparative evaluation of efficacy of conventional osteotomy vs modified osteotomy cut in surgical management of tempoprmandibular joint ankylosis patients- A randomized controlled trial This study is designed as a prospective comparative clinical study involving a total of 20 patients, who are divided into two groups of 10 patients each. Group I undergoes the conventional osteotomy cut, while Group II undergoes the modified osteotomy cut. The primary parameter evaluated is graft volume, which is assessed postoperatively at one week and again at six months to determine volume stability and resorption over time. In addition to this, secondary parameters such as pain and mouth opening are assessed within the same groups. Pain is measured using the Visual Analog Scale (VAS) at specified postoperative intervals, while mouth opening is evaluated by measuring the maximum interincisal distance to assess functional recovery. Both intergroup comparisons (between conventional and modified osteotomy groups )are performed to analyze the outcomes comprehensively. |