| CTRI Number |
CTRI/2024/11/076142 [Registered on: 01/11/2024] Trial Registered Prospectively |
| Last Modified On: |
01/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Observing the human amniotic membrane which act as a regenerative material in necrotic mature teeth.
for Reduction of infection size and regain of pulp response will be assessed at a time period of 3, 6, 9 and 12 months. |
|
Scientific Title of Study
|
Assessment of human amniotic membrane as an extracellular matrix scaffold for guided endodontic repair in necrotic mature permanent teeth- 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 |
Supriya Kumari |
| Designation |
Post graduate student |
| Affiliation |
Bapuji Educational Association (BEA) |
| Address |
Department of conservative dentistry and endodontics
Room number 6,Bapuji Dental College and Hospital, MCC B block, Davangere
Department of conservative dentistry and endodontics
Room number 6,Bapuji Dental College and Hospital, MCC B block, Davangere
Davanagere
KARNATAKA
577004
India |
| Phone |
07022867361 |
| Fax |
|
| Email |
Supriyakumaridr1234@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rashmi NC |
| Designation |
Professor and guide |
| Affiliation |
Bapuji Educational Association(BEA) |
| Address |
Department of Conservative Dentistry and Endodontics, Room number 6, Bapuji Dental College and Hospital, MCC B block, Davangere
Department of conservative dentistry and endodontics
Room number 6,Bapuji Dental College and Hospital, MCC B block, Davangere
Davanagere
KARNATAKA
577004
India |
| Phone |
7347228077 |
| Fax |
|
| Email |
ncrashmi@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rashmi NC |
| Designation |
Professor and guide |
| Affiliation |
Bapuji Dental College and Hospital Davangere |
| Address |
Department of Conservative Dentistry and Endodontics, Room number 6, Bapuji Dental College and Hospital, MCC B block, Davanagere
Department of conservative dentistry and endodontics
Room number 6,Bapuji Dental College and Hospital, MCC B block, Davanagere
Davanagere
KARNATAKA
577004
India |
| Phone |
7347228077 |
| Fax |
|
| Email |
ncrashmi@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Bapuji Dental College and Hospital, MCC B Block, MCC, Davanagere, Karnataka 577004, India |
|
|
Primary Sponsor
|
| Name |
Dr Supriya Kumari |
| Address |
Department of Conservative Dentistry and Endodontics, Room number 6, Bapuji Dental College and Hospital, MCC B block, Davangere |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Supriya Kumari |
Room number 6, Bapuji Dental College and Hospital, MCC B block Davangere, 577004 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Supriya Kumari |
Bapuji Dental College and Hospital |
Department of Conservative Dentistry and Endodontics, Room number 6, Bapuji Dental College and Hospital, MCC B block, Davangere
Davanagere
KARNATAKA |
7022867361
Supriyakumaridr1234@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bapuji Dental College and Hospital Institutional review board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Participants with necrotic teeth requiring root canal treatment |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients between 18–40 years of age with no sex predilection.
2) Non-contributory medical history.
3) Maxillary anterior with single root and single canal with closed root apex.
4) Necrotic pulp nonresponsive to thermal tests, with or without periapical
radiolucency (Periapical index score 0-2). |
|
| ExclusionCriteria |
| Details |
1) Teeth with immature roots.
2) Non restorable teeth
3) Positive response to cold testing, presence of sinus tract or swelling.
4) Pregnant and lactating mothers |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction of periapical radiolucency visually using intraoral
periapical radiograph. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Regain in pulp sensibility |
1 year |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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)
|
25/11/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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 regenerative endodontic clinical study that is assessing if human amniotic membrane can be successfully used as a scaffold in necrotic mature teeth and if can regain the pulp sensibility of upper anterior necrotic mature teeth. Reduction of periapical radiolucency and regain of pulp sensibility will be assessed at 3, 6, 9 and 12 months. |