| CTRI Number |
CTRI/2026/04/109145 [Registered on: 23/04/2026] Trial Registered Prospectively |
| Last Modified On: |
28/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical and Radiographic Healing in Participants Following Exposure to Biodentine and Bio-C Repair for Partial Pulpotomy in Carious Permanent Molars |
|
Scientific Title of Study
|
CLINICAL AND RADIOGRAPHIC OUTCOMES OF PARTIAL PULPOTOMY USING BIODENTINE AND BIO-C REPAIR IN THE MANAGEMENT OF CARIOUS MATURE PERMANENT MOLARS DIAGNOSED WITH SYMPTOMATIC IRREVERSIBLE PULPITIS : A RANDOMISED 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 Divya Grover |
| Designation |
Postgraduate Student |
| Affiliation |
Department of Conservative Dentistry and Endodontics, Himachal Dental College and Hospital |
| Address |
Himachal Dental College and Hospital Sundernagar
Sundernagar
Mandi
HIMACHAL PRADESH
175018
India |
| Phone |
8755406807 |
| Fax |
|
| Email |
dr.divya1123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shweta Verma |
| Designation |
Professor |
| Affiliation |
Deaprtment of Conservative Dentistry and Endodontics Himachal Dental College and Hospital |
| Address |
Himachal Dental College and Hospital Sundernagar
Sundernagar
Mandi
HIMACHAL PRADESH
175018
India |
| Phone |
9418476681 |
| Fax |
|
| Email |
drshwetaverma053@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijay Kumar |
| Designation |
Professor |
| Affiliation |
Deaprtment of Conservative Dentistry and Endodontics, Himachal Dental College and Hospital, |
| Address |
Himachal Dental College and Hospital Sundernagar
Sundernagar
Mandi
HIMACHAL PRADESH
175018
India |
| Phone |
7650000300 |
| Fax |
|
| Email |
drvijayvk90@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr. Divya Grover |
| Address |
Himachal Dental College and Hospital Sundernagar, Himachal Pradesh |
| 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 Divya Grover |
Himachal Dental College and Hospital Sundernagar |
Department of Conservative Dentistry and Endodontics
Mandi
HIMACHAL PRADESH |
8755406807
dr.divya1123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Himachal Dental College and Hospital 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 Molars with irreversible pulpitis treated by Partial Pulpotomy using Bio-C Repair. |
Mature Permanent Molars with irreversible pulpitis treated by partial pulpotomy using Bio-C Repair, giving a layer of base material over it and restoring it with resin composite.Recall after 1 month and 6 months for follow up. |
| Comparator Agent |
Mature Permanent Molars with irreversible pulpitis treated by partial pulpotomy using Biodentine. |
Mature Permanent Molars with irreversible pulpitis treated by partial pulpotomy using Biodentine, giving a layer of base material over it and restoring it with resin composite.Recall after 1 month and 6 months for follow up. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Non- contributory medical history
Patients with clinical presentation of spontaneous pain or pain exacerbated by cold stimuli and lasting for a few seconds to several hours and which could be reproduced using cold testing / EPT.
Positive response to cold testing with no signs of pulpal necrosis including swelling or sinus tract.
The tooth is restorable with no need for a crown or post-retained restoration.
Normal probing pocket depth and tooth mobility.
Patients with radiographic evidence of caries involving the entire thickness of dentine.
Normal periapical structures.
|
|
| ExclusionCriteria |
| Details |
Immature molars with open apex.
Radiolucency at the periapical zones or furcation.
Existence of calcification (pulp stone, diffuse calcification, disk-like chamber) and internal or external resorption.
Existence of swelling of the sinus tract and the negative response to testing.
Uncontrolled bleeding after pulpotomy lasting for more than 10 minutes.
Bleeding is not sufficient after pulp exposure; the pulp is judged partially necrotic.
Non-restorable teeth.
|
|
|
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 month and 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Outcome will be assessed on Radiographic Assessment. |
At 6 months. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/05/2026 |
| 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="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
A non surgical partial pulpotomy on Mature Permanent Molars 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 Bio-C Repair and Biodentine by treatment outcomes. |