| CTRI Number |
CTRI/2024/07/070237 [Registered on: 09/07/2024] Trial Registered Prospectively |
| Last Modified On: |
12/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Treatment outcomes of coronal pulpotomy using Amniotic Membrane versus PRF in Mandibular Molars: A Randomized Controlled Trial |
|
Scientific Title of Study
|
Comparative evaluation of treatment outcomes of coronal pulpotomy using Amniotic Membrane versus PRF in Mature Permanent Mandibular Molars diagnosed with Irreversible Pulpitis: A Randomized Controlled Trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sunaina Arora |
| Designation |
Postgraduate Junior Resident, Endo |
| Affiliation |
Himachal Dental College and Hospital |
| Address |
Himachal Dental College and Hospital, Department of Conservative Dentistry and Endodontics, Sunder Nagar, Mandi, Himachal Pradesh
Mandi
HIMACHAL PRADESH
175019
India |
| Phone |
8587945352 |
| Fax |
01907267183 |
| Email |
98sarora@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shweta Verma |
| Designation |
Professor |
| Affiliation |
Himachal Dental College and Hospital |
| Address |
Himachal Dental College and Hospital, Department of Conservative Dentistry and Endodontics, Sunder Nagar, Mandi, Himachal Pradesh
Mandi
HIMACHAL PRADESH
175019
India |
| Phone |
9418476681 |
| Fax |
01907267183 |
| Email |
drshwetaverma053@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shweta Verma |
| Designation |
Professor |
| Affiliation |
Himachal Dental College and Hospital |
| Address |
Himachal Dental College and Hospital, Department of Conservative Dentistry and Endodontics, Sunder Nagar, Mandi, Himachal Pradesh
Mandi
HIMACHAL PRADESH
175019
India |
| Phone |
9418476681 |
| Fax |
01907267183 |
| Email |
drshwetaverma053@gmail.com |
|
|
Source of Monetary or Material Support
|
| Material Support: TATA Memorial Hospital Tissue Bank, Dr.Ernest Borges Road, Parel, Mumbai 400012 (Amniotic Membrane) |
|
|
Primary Sponsor
|
| Name |
Dr Sunaina Arora |
| Address |
Himachal Dental College and Hospital, Department of Conservative Dentistry and Endodontics, Sunder Nagar, Mandi, Himachal Pradesh 175019 |
| 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 |
| Dr Shweta Verma |
Himachal Dental College and Hospital |
Department of Conservative Dentistry and Endodontics, Sunder Nagar, Mandi
Mandi
HIMACHAL PRADESH |
9418476681
drshwetaverma053@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE OF HIMACHAL DENTAL COLLEGE, SUNDERNAGAR |
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 |
Mature Permanent Mandibular Molar with irreversible pulpitis treated by coronal pulpotomy using PRF |
Mature Permanent Mandibular Molars with irreversible pulpitis treated by coronal pulpotomy using PRF Membrane, giving a layer of Calcium silicate-based material over it and restoring it with RMGIC and Composite. Recall after 1 week for follow up. |
| Intervention |
Mature Permanent Mandibular Molars with irreversible pulpitis treated by Coronal Pulpotomy using Amniotic Membrane |
Mature Permanent Mandibular Molars with irreversible pulpitis treated by Coronal pulpotomy using Amniotic Membrane, giving a layer of Calcium silicate-based material over it and restoring it with RMGIC and Composite. Recall after 1 week for follow up. |
| Comparator Agent |
Mature Permanent Mandibular Molars with irreversible pulpitis treated by coronal pulpotomy using Calcium Silicate-based materials |
Mature Permanent Mandibular Molars with irreversible pulpitis treated by coronal pulpotomy using Calcium silicate-based materials and restoring with RMGIC and Composite. Recall after 1 week for follow up. |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Periapical widening(mild)
Sensitivity to hot and cold
Acute pain
Tenderness on percussion may or may not be present
Mandibular first and second permanent molar
Limited carious extent that does not require prosthetic treatment |
|
| ExclusionCriteria |
| Details |
Periapical lesion
Excessive coronal damage due to caries
Pregnancy
Chronic lesion
History of pain, long back
Presence of swelling
Presence of mobility
Periodontal involvement |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Outcome will be assessed on Clinical Evaluation and Radiographic Assessment. |
At 1 week, 3 months and 6months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Outcome will be assessed on Radiographic assessment |
3 months |
|
|
Target Sample Size
|
Total Sample Size="30"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/07/2024 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A nonsurgical pulpotomy on Mature Permanent Mandibular Molar with irreversible pulpitis confirmed by Clinical evaluation, Radiographic assessment and EPT response. Based on inclusion and exclusion criteria, samples will be chosen, and recruitment will be done. Comparing the efficacy of Amniotic Membrane, PRF and Calcium Silicate-based materials by treatment outcomes. |