| CTRI Number |
CTRI/2026/02/104865 [Registered on: 26/02/2026] Trial Registered Prospectively |
| Last Modified On: |
24/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Stem Cell Therapy
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Regenerative action of amniotic membrane in tooth |
|
Scientific Title of Study
|
One year follow up of Clinical outcome of Direct Pulp Capping using Amniotic membrane in
permanent teeth |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Roma M |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Dental Sciences Mangalore |
| Address |
Manipal College of Dental Sciences
Dept of Conservative Dentistry and Endodontics
Room number 3
Light House hill road
Light House Hill Road Hampankatta
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
09902338318 |
| Fax |
|
| Email |
roma.m@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Roma M |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Dental Sciences Mangalore |
| Address |
Manipal College of Dental Sciences
Dept of Conservative Dentistry and Endodontics
Room number 3
Light House hill road
Light House Hill Road Hampankatta
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
09902338318 |
| Fax |
|
| Email |
roma.m@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Roma M |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Dental Sciences Mangalore |
| Address |
Manipal College of Dental Sciences
Dept of Conservative Dentistry and Endodontics
Room number 3
Light House hill road
Light House Hill Road Hampankatta
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
09902338318 |
| Fax |
|
| Email |
roma.m@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Amniotic membrane
Dr E Borges Road
Parel Mumbai 400012
Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Homi Babha Building, Dr Ernest Borges Rd, Parel East, Parel, Mumbai, Maharashtra 400012 INDIA |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Tata Memorial Hospital |
Homi Babha Building, Dr Ernest Borges Rd, Parel East, Parel, Mumbai, Maharashtra 400012 INDIA |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Roma M |
Manipal College of Dental Sciences |
Department of Conservative Dentistry and Endodontics
Room number 3, Light House Hill road
Light House Hill Road Hampankatta
575001
Dakshina Kannada
KARNATAKA |
09902338318
roma.m@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee MCODS Mangalore |
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 |
Amniotic membrane |
The infected soft caries will be excavated using sterile sharp spoon excavator. Bleeding will be controlled with 2.5% NaOCl (Vishal Dentocare Pvt Ltd.) soaked sterile cotton plug. The disinfection of the cavity will be done with 2% Chlorhexidine gluconate solution. Amnoitic membrane (Tata memorial Hospital, Mumbai) will be applied as pulp capping material followed by restoration with glass ionomer (GC Glass Ionomer Universal Restorative) restoration. |
| Comparator Agent |
Calcium hydroxide |
The infected soft caries will be excavated using sterile sharp spoon excavator. Bleeding will be controlled with 2.5% NaOCl (Vishal Dentocare Pvt Ltd.) soaked sterile cotton plug. The disinfection of the cavity will be done with 2% Chlorhexidine gluconate solution. Amnoitic membrane (Tata memorial Hospital, Mumbai) will be applied as pulp capping material followed by restoration with glass ionomer (GC Glass Ionomer Universal Restorative) restoration. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Symptomatic teeth with deep carious lesion having mild pain, mild tenderness and sensitivity to cold beverages and without any radiolucency or periapical changes in the intraoral periapical radiograph |
|
| ExclusionCriteria |
| Details |
1. Symptomatic cases with severe pain, swelling/extraoral swelling, intraoral sinus
2. Presence of periapical changes in radiograph
3. Medical history such as diabetes mellitus, immune-deficient conditions
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
-Tertiary dentin formation
-Dentin bridge formation |
baseline,4weeks and 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Maintain functional integrity of teeth |
1 month
6 months
1 year |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
12/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
12/03/2026 |
| 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)
|
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 purpose of this clinical trial was to assess the clinical result of DPC procedure using amniotic membrane by collating the pre- and post-operative pain (Visual Analogue Scale) and radiographic features. In this study, 10 cases with symptomatic cases with normal periapical architecture were decided. The patients were treated with direct pulp capping with amniotic membrane under rubber dam and permanent restoration was done using sandwich technique with Glass ionomer cement and composite resin. The subjects were recalled at various time intervals (1 month, 3 months, 6 months and 12 months) for follow up visits to evaluate the clinical and radiographic outcomes. |