| CTRI Number |
CTRI/2025/12/099118 [Registered on: 15/12/2025] Trial Registered Prospectively |
| Last Modified On: |
13/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Mandibular Bone Resorption After Tooth Loss and Its Impact on the Overall Health of an Individual |
|
Scientific Title of Study
|
Radiological Evaluation of Mandibular Residual Ridge Resorption and Its Correlation with Systemic Biochemical Markers in Completely Edentulous Participants A Clinical 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 |
Chandrika Priyadarshini Mishra |
| Designation |
Post graduate Resident |
| Affiliation |
SCB DENTAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF PROSTHODONTICS AND CROWN AND BRIDGE
SCB DENTAL COLLEGE CUTTACK
Cuttack
ORISSA
753001
India |
| Phone |
9337606055 |
| Fax |
|
| Email |
cpmishra00@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tapan Kumar Patro |
| Designation |
Head of Department |
| Affiliation |
SCB DENTAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF PROSTHODONTICS AND CROWN AND BRIDGE
SCB DENTAL COLLEGE CUTTACK
Cuttack
ORISSA
753001
India |
| Phone |
|
| Fax |
|
| Email |
tapankumarpatro@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Chandrika Priyadarshini Mishra |
| Designation |
PG STUDENT |
| Affiliation |
SCB DENTAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF PROSTHODONTICS AND CROWN AND BRIDGE
SCB DENTAL COLLEGE CUTTACK
Cuttack
ORISSA
753001
India |
| Phone |
9337606055 |
| Fax |
|
| Email |
cpmishra00@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Chandrika Priyadarshini Mishra |
| Address |
DEPARTMENT OF PROSTHODONTICS AND CROWN AND BRIDGE
SCB DENTAL COLLEGE CUTTACK
ODISHA 753001 INDIA |
| 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 |
| CHANDRIKA PRIYADARSHINI MISHRA |
SCB DENTAL COLLEGE AND HOSPITAL |
DEPARTMENT OF PROSTHODONTICS AND CROWN AND BRIDGE
SCB DENTAL COLLEGE CUTTACK
753001
ODISHA
Cuttack
ORISSA |
09337606055
dentalscb@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE SCB DENTAL COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
COMPLETELY EDENTULOUS PARTICIPANTS |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Day(s) |
| Age To |
80.00 Day(s) |
| Gender |
Both |
| Details |
The participants will be completely edentulous for more than 1 year and aged between 45 and 80 years reporting to the Dept of Prosthodontics and Crown & Bridge SCB DENTAL COLLEGE & HOSPITAL, CUTTACK. |
|
| ExclusionCriteria |
| Details |
who have undergone pre -prosthetic surgery like sulcus deepening or ridge augmentation.
Patients with maxillary and mandibular defects.
Patients with neurological deficits.
Patients with metabolic bone diseases.
Patients with cancers |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to establish a correlation between systemic marker with bone reorption |
1.5 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to establish a correlation between systemic marker with bone reorption |
1 |
|
|
Target Sample Size
|
Total Sample Size="53"
Sample Size from India="53"
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)
|
24/12/2025 |
| 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="15" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
This is a observational study for thesis purpose where the sample size is 53 with above mentioned inclusion and exclusion criteria .Main objective of the study is to establish the correalation between the systemic comarker and bone resorption in edentulous participants enrolled in the study. |