| CTRI Number |
CTRI/2025/11/098092 [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 Materials for Saving Permanent Molars Through Pulpotomy Treatment |
|
Scientific Title of Study
|
Outcome Study of Pulpotomy Technique with Portland Cement as an Economic Alternative Of MTA in Permanent Molars Diagnosed as Moderate to Severe Symptomatic Pulpitis-A Randomized Controlled Trial |
| Trial Acronym |
PORTLAND |
|
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
Darjiling
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
Darjiling
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
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 |
Mineral Trioxide Aggregate (MTA) |
Pulpotomy will be performed in the same manner using a high-speed air-rotor and removal of coronal pulp up to the orifice level. Bleeding indicative of vital radicular pulp will be assessed under magnification. Hemostasis will be achieved similarly using sterile saline-soaked cotton pellets. Following hemostasis, a 3 mm thickness of MTA will be placed over the pulp tissue. After initial setting, teeth will be restored with glass ionomer cement. Will be reviewed at 1,3,and 6 months. |
| Intervention |
Portland Cement |
Pulpotomy will be performed using a high-speed air-rotor handpiece. Coronal pulp tissue will be removed up to the canal orifice level. Vitality of the radicular pulp will be confirmed based on bleeding observed under magnification. Hemostasis will be achieved using sterile saline-soaked cotton pellets applied with gentle pressure for up to five minutes. Once hemostasis is achieved, a 3 mm thickness of Portland Cement will be placed directly over the vital radicular pulp. After setting, the tooth will be restored with glass ionomer cement. Will be reviewed at 1,3,and 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 Rate |
1,3,6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Radiographic Success Rate |
1,3,6 months |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
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)
|
10/12/2025 |
| 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 study is a randomized, parallel-group interventional clinical trial designed to compare the clinical and radiographic outcomes of pulpotomy performed using Portland Cement (experimental material) versus Mineral Trioxide Aggregate (standard material) in permanent molars diagnosed with moderate to severe symptomatic pulpitis. Eligible adult participants will be randomly allocated into two treatment groups using simple randomization through a coin-toss method. Allocation will be concealed using sequentially numbered opaque sealed envelopes. Clinical and radiographic follow-up will be conducted at 1, 3, 6, and 12 months to assess treatment success, postoperative symptoms, and signs of periapical pathology. The findings may help determine whether Portland Cement can serve as a cost effective alternative to MTA for pulpotomy in permanent teeth. |