| CTRI Number |
CTRI/2025/11/098093 [Registered on: 26/11/2025] Trial Registered Prospectively |
| Last Modified On: |
25/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing two pulpotomy treatment methods for painful permanent teeth. |
|
Scientific Title of Study
|
Comparative Outcome Study of Tampon Pulpotomy Technique with Conventional Pulpotomy in Permanent Molars Diagnosed as Moderate to Severe Symptomatic 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 |
Debjyoti Karmakar |
| Designation |
Associate Professor |
| Affiliation |
North Bengal Dental College and Hospital |
| Address |
Department of Conservative Dentistry and Endodontics,North Bengal Dental College and Hospital,Darjeeling
Darjiling
WEST BENGAL
734012
India |
| Phone |
9733048062 |
| Fax |
|
| Email |
drdebjyoti@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Debjyoti Karmakar |
| Designation |
Associate Professor |
| Affiliation |
North Bengal Dental College and Hospital |
| Address |
Department of Conservative Dentistry and Endodontics,North Bengal Dental College and Hospital,Darjeeling
WEST BENGAL
734012
India |
| Phone |
9733048062 |
| Fax |
|
| Email |
drdebjyoti@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Debjyoti Karmakar |
| Designation |
Associate Professor |
| Affiliation |
North Bengal Dental College and Hospital |
| Address |
Department of Conservative Dentistry and Endodontics,North Bengal Dental College and Hospital,Darjeeling
WEST BENGAL
734012
India |
| Phone |
9733048062 |
| Fax |
|
| Email |
drdebjyoti@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Conservative Dentistry and Endodontics, North Bengal Dental College and Hospital, Sushrutnagar, District:Darjeeling,Pincode-734012,State:West Bengal,Country:India |
|
|
Primary Sponsor
|
| Name |
DrDebjyoti Karmakar |
| Address |
Dr.Debjyoti Karmakar Associate professor,Department of Conservative Dentistry and Endodontics, North Bengal Dental College and Hospital, Sushrutnagar, District-Darjeeling,Pincode-734012,State-West Bengal,Country-India |
| Type of Sponsor |
Other [Government Dental College] |
|
|
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 |
| Debjyoti Karmakar |
North Bengal Dental College and Hospital |
Department of Conservative Dentistry and Endodontics, North Bengal Dental College and Hospital, Sushrutnagar, District:Darjeeling,Pincode-734012,State:West Bengal,Country:India
WEST BENGAL
Darjiling
WEST BENGAL |
9733048062
drdebjyoti@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of North Bengal Medical College and Hospital |
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 |
Conventional Pulpotomy |
pulpotomy procedure will be performed using a high speed air-rotor handpiece and the coronal pulp tissue will be removed to orifice level. Associated bleeding indicative of radicular pulp vitality will be judged under magnified view. Hemostasis will be achieved with 2.5% sodium hypochlorite soaked small cotton pellets with gentle application of pellets for up to five minutes. After hemostasis, over the vital radicular pulp, 3mm thickness Biodentine will be placed, and then all teeth will be restored with restorative glass-ionomer cement.Review will be done at 1,3,and 6 months |
| Intervention |
Tampon Pulpotomy |
Pulpotomy procedure will be performed as par the protocol of the inventors Dr Asgari et. al. using a high speed air-rotor hand piece and the coronal pulp tissue will be removed to orifice level. Associated bleeding indicative of radicular pulp vitality will be judged under magnified view. Hemostasis will be achieved by placing tampon of Biodentine over the vital radicular pulp over it another 3mm thickness Biodentine will be placed, and then all teeth will be restored with restorative glass-ionomer cement.Review will be done at 1,3,6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
(1) Permanent mature molar teeth with a probing pocket depth and mobility within normal limits;
(2) With a carious lesion reaching the middle or inner third of dentine.
(3) With a pre-operative diagnose of moderate to severe symptomatic pulpitis as par Indian Endodontic Society (IES) Pulpal Diagnostic Classification.
(4) No signs of sinus tract or swelling.
(5) Periapical radiograph indicated a normal periapical status (PAI score 1).
|
|
| ExclusionCriteria |
| Details |
(1) Pulpal exposure of traumatic origin.
(2) Patients with systemic disease that could affect the outcome of treatment.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Clinical success of pulpotomy based on cold test and clinical findings. Outcome classified as:
(1) Success: Positive cold response and no symptoms;
(2) Uncertain: No cold response but no symptoms;
(3) Failure: No cold response with symptoms. |
Baseline (pre-treatment)
1 month follow-up,3 month follow-up,6 month follow-up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Radiographic Success-Radiographic success based on absence of periapical/pathologic changes. Categorized as:
(1) Success: No radiolucency or resorption;
(2) Uncertain: Minimal changes not indicative of disease;
(3) Failure: Radiolucency, resorption, or signs of pathology. |
Assessed at Baseline(pre-operative),1,3 & 6 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
|
N/A |
|
Date of First Enrollment (India)
|
12/12/2025 |
| 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="0"
Months="9"
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 randomized controlled trial aims to compare two pulpotomy techniques used for treating painful deep caries in permanent molars. One group will receive the newer tampon pulpotomy technique, where the material is placed directly to help stop bleeding and seal the pulp immediately. The other group will receive the conventional pulpotomy method, where bleeding is first controlled before the sealing material is placed. Eligible adult participants with moderate to severe symptomatic pulpitis will be randomly assigned to one of the two treatment groups. All procedures will be performed under local anesthesia, and follow-up clinical examinations and X-rays will be conducted at 1, 3, 6, and 12 months to assess healing and treatment success. The results may help determine whether tampon pulpotomy can serve as an effective and simpler alternative to conventional pulpotomy in permanent teeth. |