| CTRI Number |
CTRI/2025/03/082520 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
12/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Recording the jaw movement using bite records and radiographs and comparing the values. |
|
Scientific Title of Study
|
Comparative evaluation of sagittal condylar inclination measured using a semi-adjustable articulator and with lateral cephalometric tracings in dentate individuals-an in vivo study |
| 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 Sanchari Chakraborty |
| Designation |
2ND YEAR PGT |
| Affiliation |
SCB DENTAL COLLEGE AND HOSPITAL,CUTTACK,ODISHA,753007 |
| Address |
DEPT OF PROSTHODONTICS AND CROWN & BRIDGE;
SCB DENTAL COLLEGE AND HOSPITAL,CUTTACK,ORISSA
Cuttack
ORISSA
753007
India |
| Phone |
08759586839 |
| Fax |
|
| Email |
sanchari051096@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Tapan Kumar Patro |
| Designation |
Head of department |
| Affiliation |
SCB DENTAL COLLEGE AND HOSPITAL,CUTTACK,ODISHA,753007 |
| Address |
DEPT OF PROSTHODONTICS AND CROWN & BRIDGE;
SCB DENTAL COLLEGE AND HOSPITAL,CUTTACK,ORISSA
Cuttack
ORISSA
753007
India |
| Phone |
9437273717 |
| Fax |
|
| Email |
tapankumarpatro8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanchari Chakraborty |
| Designation |
PGT 2nd Year,Dept of Prosthodontics and crown and bridge |
| Affiliation |
SCB DENTAL COLLEGE AND HOSPITAL,CUTTACK,ODISHA,753007 |
| Address |
DEPT OF PROSTHODONTICS AND CROWN & BRIDGE;
SCB DENTAL COLLEGE AND HOSPITAL,CUTTACK,ORISSA
Cuttack
ORISSA
753007
India |
| Phone |
08759586839 |
| Fax |
|
| Email |
sanchari051096@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPT OF PROSTHODONTICS AND CROWN & BRIDGE;
SCB DENTAL COLLEGE AND HOSPITAL,CUTTACK,ORISSA |
|
|
Primary Sponsor
|
| Name |
Dr Sanchari Chakraborty |
| Address |
SCB DENTAL COLLEGE AND HOSPITAL,CUTTACK |
| Type of Sponsor |
Other [SELF] |
|
|
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 Sanchari Chakraborty |
SCB DENTAL COLLEGE AND HOSPITAL |
DEPT OF PROSTHODONTICS AND CROWN & BRIDGE POST GRADUATE SECTION
Cuttack
ORISSA |
8759586839
sanchari051096@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee(IEC),SCBDCH,CUTTACK |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Participants with stable maximum intercuspation |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
Stable maximum intercuspation, Angles Class 1 molar relation, Anterior teeth should be present(natural/restored) |
|
| ExclusionCriteria |
| Details |
TMJ disorders,crowding,gross attrition,periodontal disease and poor oral hygiene,severe systemic disorders and pregnancy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| sagittal condylar inclination values |
0 and 1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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
|
N/A |
|
Date of First Enrollment (India)
|
24/03/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Fabricating an accurate prosthesis requires precise recording of the maxillo-mandibular relationship of the patient and then transferring them to an articulator.The semi- adjustable articulators can record condylar inclination values in the form of horizontal and lateral condylar inclinations using protrusive records. However ,in patients suffering from various neurological and neuromuscular disorders,recording this value becomes cumbersome due to poor neuromuscular control and irregular jaw movements.Thus,radiographic methods have been employed in such scenarios due to stable bony landmarks. In this study, the aim was to compare and evaluate the correlation between sagittal condylar inclination measured using a semi-adjustable articulator and superimposition of lateral cephalometric tracings (manual method and AI based AUDAXCEPH software). |