| CTRI Number |
CTRI/2025/04/085109 [Registered on: 17/04/2025] Trial Registered Prospectively |
| Last Modified On: |
15/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
An observational trial to study the changes in the cortical bone thickness in edentulous areas within 1 year, 1 to 3 years and more than 3 years after extraction of teeth. |
|
Scientific Title of Study
|
Assesment of cortical bone thickness in edentulous area using trephine bur |
| Trial Acronym |
STROBE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kumar Abhishek |
| Designation |
Post Graduate Student |
| Affiliation |
Hazaribag College Of Dental Sciences and Hospital. |
| Address |
Dr. Kumar Abhishek
Hazaribag College Of Dental Sciences and Hospital.
Campus Demotand, Off National Highway 33.
Hazaribag
JHARKHAND
825301
India |
| Phone |
7001659083 |
| Fax |
|
| Email |
abhisheksinhaking@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shekhar Prashant |
| Designation |
Professor & Head of the Department |
| Affiliation |
Hazaribag College Of Dental Sciences and Hospital. |
| Address |
Department of Periodontology.
Hazaribag College Of Dental Sciences and Hospital.
Campus Demotand, Off National Highway 33.
Hazaribag
JHARKHAND
825301
India |
| Phone |
9199223333 |
| Fax |
|
| Email |
drshekharprashant@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kumar abhishek |
| Designation |
Post Graduate Student |
| Affiliation |
Hazaribag College Of Dental Sciences and Hospital. |
| Address |
Dr. Kumar Abhishek
Hazaribag College Of Dental Sciences and Hospital.
Campus Demotand, Off National Highway 33.
Hazaribag
JHARKHAND
825301
India |
| Phone |
7001659083 |
| Fax |
|
| Email |
abhisheksinhaking@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hazaribag College Of Dental Sciences and Hospital. |
|
|
Primary Sponsor
|
| Name |
Hazaribag College Of Dental Sciences and Hospital |
| Address |
Hazaribag College Of Dental Sciences and Hospital.
Campus Demotand, Off National Highway 33 |
| Type of Sponsor |
Other [Private dental college and hospital] |
|
|
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 |
| DrKumar Abhishek |
Hazaribag College Of Dental Sciences and Hospital. |
Department of periodontology Room n.o 10,Post Graduate Division ,Hazaribag College Of Dental Sciences and Hospital.Campus Demotand, Off National Highway 33.
Hazaribag
JHARKHAND |
07001659083
abhisheksinhaking@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| HCDSHIEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
partial/complete edentulous patients. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nill |
Nill |
| Intervention |
Nill |
Nill |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients in good general health.
2.Patients with edentulous ridges/spaces.
3.Patient with no abusive habit. |
|
| ExclusionCriteria |
| Details |
-Patients allergic to local
anasthesia,antibiotics,analgesics.
-Having habit of smoking ,tobacco chewing.
-pregnant lactating women.
-patients already wearing prosthesis.
-Systemically compromised patients.
-Tooth loss due to road traffic accident /trauma. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Age related changes in the alveolar bone. |
Extraction site less the 1 year,
Extraction site 1 to 3 year ,
Extraction site more than 3 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Age related changes in cortical bone thickness in post extraction sites at different time intervals. |
Extraction site 0 to 1 year,1 to 2 years , more than 2 years. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
02/06/2025 |
| 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="0"
Months="0"
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 - NO
|
|
Brief Summary
|
The study will be done by taking out a part of a bone by using trephine bur and further doing evaluation of the same patients .Patients with edentulous ridges/spaces and who sucessfully fulfill all inclusion criteria , will be subjected for taking specimen of alveolar ridges.Prior to procedure , a consent form of approval will be given to patients ,which will be filled by patients.Selection of patient will be done on the duration of edentulism . Group A Extraction less than 1 year. Group B Extraction more than 1 year but less than 2 years. Group C Extraction more than 2 years. Taken sample will be evaluated histologically and thickness and age changes will be seen by analysing samples. |