| CTRI Number |
CTRI/2026/02/104517 [Registered on: 23/02/2026] Trial Registered Prospectively |
| Last Modified On: |
22/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Knowledge About Pulpotomy Treatment In Patients. |
|
Scientific Title of Study
|
Comparative Evaluation Of Clinical Effectiveness And Radiographic Outcome Of MTA, Biodentine, And Cerafill Putty In Full Pulpotomy In Teeth With Symptomatic Irreversible Pulpitis - A Aandomized 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 Roma M |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Dental Sciences Mangalore |
| Address |
Manipal College of Dental Science Light House Hill Road
Light House Hill Road Hampankatta
Mangalore 575001
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
09902338318 |
| Fax |
|
| Email |
roma.m@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Roma M |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Dental Sciences Mangalore |
| Address |
Manipal College of Dental Science Light House Hill Road
Light House Hill Road Hampankatta
Mangalore 575001
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
09902338318 |
| Fax |
|
| Email |
roma.m@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Roma M |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Dental Sciences Mangalore |
| Address |
Manipal College of Dental Science Light House Hill Road
Light House Hill Road Hampankatta
Mangalore 575001
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
09902338318 |
| Fax |
|
| Email |
roma.m@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College of Dental Sciences Mangalore |
|
|
Primary Sponsor
|
| Name |
Septodont |
| Address |
Plot No. C-1/2 Ground Floor Navade MIDC Industrial Area Taloja Navi Mumbai Thane Maharashtra India 410208 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Biodentine |
Plot No. C-1/2 Ground Floor Navade MIDC Industrial Area Taloja Navi Mumbai Thane Maharashtra India 410208 |
| Cerfill Putty |
EPIP Kartholi Bari Brahmana Samba Jammu & Kashmir India 181133 |
|
|
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 |
Room 3, Department of Conservative Dentistry and Endodontics
MCODS
Light House Hill Road
Hampankatta
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 |
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 |
| Comparator Agent |
Pulpotomy With Biodentine |
Biodentine has a wide range of applications including endodontic repair (root perforations, apexification, resorptive lesions, and retrograde filling material in endodontic surgery) and pulp capping and can be used as a dentine replacement material in restorative dentistry. |
| Intervention |
Pulpotomy With Mineral Trioxide Aggregate |
A Powder mixed with water, primarily Portland cement, bismuth oxide (for radiopacity), and other silicates, creating calcium silicate hydrate and calcium hydroxide upon setting, which are bioactive. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Teeth with mature apex
Positive response to cold test
Caries extension into the pulp or greater than two-thirds of dentine on the radiograph
Normal probing depth and mobility |
|
| ExclusionCriteria |
| Details |
Grossly decayed teeth
Presence of pulpal necrosis (signs of sinus tract/abscess/ swelling)
No response to the cold test
Caries limited to dentin on mechanical excavation
Failure to achieve hemostasis within 10 minutes following complete pulpotomy |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the clinical effectiveness and radiographic outcome of full pulpotomy with MTA, Biodentine, and Cerafill putty in mature teeth with symptomatic irreversible pulpits without apical periodontitis at baseline, 4 weeks & 8 weeks. |
baseline
4 weeks
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate clinical effectiveness of full pulpotomy of MTA, Biodentine, and Cerafill putty in mature teeth with symptomatic irreversible pulpits without apical periodontitis at 1month, 3months, 6 months and 12 months. |
0,1,3, 6 and 12 months |
|
|
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
05/03/2026 |
| 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="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 study aims to evaluate the outcomes of full pulpotomy using two calcium silicate-based materials compared to MTA in symptomatic mature permanent teeth with carious pulp exposure. Preoperative and intraoperative variables will also be assessed, with the null hypothesis positing no difference in outcomes among the three materials. |