| CTRI Number |
CTRI/2022/09/045227 [Registered on: 05/09/2022] Trial Registered Prospectively |
| Last Modified On: |
07/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Stem Cell Therapy
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Studying the role of a fetal membranes for treatment of decayed teeth in the mouth. |
|
Scientific Title of Study
|
Amniotic membrane as a therapeutic agent for pulpotomy in permanent molars: A Randomised controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Saumya Johri |
| Designation |
Senior Resident |
| Affiliation |
KGMU |
| Address |
DEPT OF CONSERVATIVE DENTISTRY AND ENDODONTICS,FIRST FLOOR, OLD DENTAL BUILDING FACULTY OF DENTAL SCIENCES KING GEORGES MEDICAL UNIVERSITY CHOWK
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
8840854587 |
| Fax |
|
| Email |
saumya.johry@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saumya Johri |
| Designation |
Senior Resident |
| Affiliation |
KGMU |
| Address |
DEPT OF CONSERVATIVE DENTISTRY AND ENDODONTICS,FIRST FLOOR, OLD DENTAL BUILDING FACULTY OF DENTAL SCIENCES KING GEORGES MEDICAL UNIVERSITY CHOWK
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
8840854587 |
| Fax |
|
| Email |
saumya.johry@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Promila Verma |
| Designation |
Professor |
| Affiliation |
KGMU |
| Address |
DEPT OF CONSERVATIVE DENTISTRY AND ENDODONTICS,FIRST FLOOR, OLD DENTAL BUILDING FACULTY OF DENTAL SCIENCES KING GEORGES MEDICAL UNIVERSITY CHOWK
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
|
| Fax |
|
| Email |
promilarajesh@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| KING GEORGES MEDICAL UNIVERSITY |
|
|
Primary Sponsor
|
| Name |
Saumya Johri |
| Address |
DEPT OF CONSERVATIVE DENTISTRY AND ENDODONTICS,FIRST FLOOR, OLD DENTAL BUILDING FACULTY OF DENTAL SCIENCES KING GEORGES MEDICAL UNIVERSITY CHOWK
|
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Promila Verma |
DEPT OF CONSERVATIVE DENTISTRY AND ENDODONTICS,FIRST FLOOR, OLD DENTAL BUILDING FACULTY OF DENTAL SCIENCES KING GEORGES MEDICAL UNIVERSITY CHOWK
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Saumya Johri |
Department of conservative dentistry and endodontics, KGMKU |
First floor, Old dental building, Faculty of dental sciences, KGMU ,Chowk.
Lucknow
UTTAR PRADESH |
8840854587
saumya.johry@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Amnion (AM) |
Amniotic membrane procured as a freeze-dried gamma-irradiated graft from the tissue bank of Tata Memorial hospital(Mumbai) will be placed inside the pulp cavity of the teeth.This procedure is carried out in one sitting of about 15-20 minutes. Amnion degrades in a few weeks after it is placed inside the pulp chamber.The tooth will be followed up for clinical and radiographical success at 1,3 and 9 month. |
| Comparator Agent |
Mineral Trioxide Aggregate(MTA) |
MTA which is a bioceramic cement containing calcium silicates, aluminate and oxide as primary ingredients used in dentistry will be placed inside the pulp space of the teeth in one single sitting.Follow-up time periods- 1,3 and 9 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
44.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients between the age 18-35 years who give written consent to participate in the study.
2) Permanent molars having pulp exposure due to deep caries.
|
|
| ExclusionCriteria |
| Details |
1) Immature teeth
2) Patients showing clinical signs and symptoms of abscess/fistula, tenderness on percussion, and mobility.
3) Teeth showing radiographic signs of periapical pathology, furcation pathology and/or resorption.
4) Non-vital teeth.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Clinical success of pulpotomy.
Evaluated by absence of signs and symptoms such as pain, inflammation, abscess/sinus, mobility, and crown failure |
1, 3 and 9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Radiographical success of pulpotomy.
Evaluated by evaluating for pathological internal or external resorption, presence of calcifications and integrity of lamina dura |
1, 3 and 9 months |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "28"
Final Enrollment numbers achieved (India)="28" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/09/2022 |
| Date of Study Completion (India) |
21/09/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
21/09/2023 |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The current study is a randomized, double-blinded, parallel-group, single-center study. The study will be done in the Department of Endodontics of KGMU, Lucknow. The primary objective is to evaluate the efficacy of freeze-dried, gamma-irradiated amniotic membrane(AM) in pulpotomy of carious teeth with irreversible pulpitis and to compare it with mineral trioxide aggregate(MTA) that is one of the accepted standard treatment for vital pulp procedures of the teeth. Evaluation will be done by calculating the clinical and radiographical success at 1,3 and 9 months after the procedure.
The amniotic membrane will be availed from the tissue bank of Tata Memorial Hospital, Mumbai. Pro Root MTA from Dentsply(Switzerland) will be the comparator.
The primary outcomes of the study are- 1)Clinical success percentage for both groups.(AM and MTA)
The secondary outcomes of the study are- 1)Radiographical success percentage of both groups.
Time points of evaluation are 1, 3, and 9 months after the procedure. |