| CTRI Number |
CTRI/2025/07/089989 [Registered on: 02/07/2025] Trial Registered Prospectively |
| Last Modified On: |
01/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two types of pulpotomy treatments using biodentine in adult teeth with deep cavities and severe tooth pain : A Randomized Controlled Trail |
|
Scientific Title of Study
|
Clinical and radiographic outcomes of full and partial pulpotomy using Biodentine in the management of carious mature permanent molars diagnosed with symptomatic irreversible pulpitis: A Randomized Controlled Trail |
| 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 Chahat |
| Designation |
Postgraduate Student |
| 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 |
9418772900 |
| Fax |
01907267183 |
| Email |
chahatkaushal1992@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 |
01907267183 |
| Email |
drshwetaverma053@gmail.com |
|
Details of Contact Person
Public 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 |
01907267183 |
| Email |
drshwetaverma053@gmail.com |
|
|
Source of Monetary or Material Support
|
| Himachal Dental College and Hospital, Sundernagar District Mandi, Himachal Pradesh, 175019 ,India |
|
|
Primary Sponsor
|
| Name |
Dr Chahat |
| Address |
Himachal Dental College and Hospital, Sundernagar
Sundernagar District Mandi, Himachal Pradesh 175019, India |
| 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 Chahat |
Himachal Dental College and Hospital |
Department of Conservative Dentistry and Endodontics, Sundernagar, Mandi, Himachal Pradesh
Mandi
HIMACHAL PRADESH |
9418772900
chahatkaushal1992@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee 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 |
| Comparator Agent |
Full pulpotomy |
Full pulpotomy involves removing all the pulp from the tooth’s crown while keeping the root pulp intact. A protective material like Biodentine is then applied to help the remaining pulp heal and preserve the tooth’s vitality. |
| Intervention |
Partial pulpotomy |
Partial pulpotomy involves removing only the inflamed part of the tooth’s pulp and covering the healthy part with a protective material like Biodentine. This helps the pulp heal and keeps the tooth alive. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Mature first and second (upper and lower) molar tooth.
Patients with clinical presentation of spontaneous pain or pain exacerbated by cold stimuli and lasting for a few seconds to several hours (interpreted as lingering pain) and which could be reproduced using cold testing or 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
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Outcome will be assessed on Clinical Evaluation and Radiographic Assesment. |
At 1 week, 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Outcome will be assessed on Radiographic Assessment. |
3 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
15/07/2025 |
| 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 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
|
This study evaluates the effectiveness of full and partial pulpotomy using Biodentine in treating decayed mature permanent molars diagnosed with symptomatic irreversible pulpitis. Both clinical and radiographic outcomes were assessed to determine which technique better preserves tooth vitality and promotes healing. The results suggest that both approaches can be successful alternatives to root canal treatment, offering effective pain relief and maintaining the health of the remaining pulp tissue.
|