| CTRI Number |
CTRI/2025/05/087413 [Registered on: 22/05/2025] Trial Registered Prospectively |
| Last Modified On: |
22/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
An investigation into the efficacy of various lining materials used in conjunction with full pulpotomy for treating symptomtic irreversible pulpitis in permanent molars |
|
Scientific Title of Study
|
A Clinical trial to assess the impact of full pulpotomy with varying lining materials in permanent molars with symptomatic irreversible pulpitis. |
| 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 Rajshree Verma |
| Designation |
pg student |
| Affiliation |
Inderprastha Dental College and Hospital |
| Address |
Department of Conservative Dentistry and Endodontics, PG Section, Room no.1, First Floor, 46/1, sahibabad industrial area site 4, sahibabad, ghaziabad, uttar pradesh
Department of Conservative Dentistry and Endodontics, PG Section, Room no.1, First Floor, 46/1, sahibabad industrial area site 4, sahibabad, ghaziabad, uttar pradesh
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
8800439626 |
| Fax |
|
| Email |
rajshreeverma221196@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nidhi Sharma |
| Designation |
Reader |
| Affiliation |
Inderprastha Dental College and Hospital |
| Address |
Department of Conservative Dentistry and Endodontics, P.G section. Room no. 1, First floor, 46/1, sahibabad industrial area site 4, sahibabad, ghaziabad, uttar pradesh
Department of Conservative Dentistry and Endodontics, P.G section. Room no. 1, First floor, 46/1, sahibabad industrial area site 4, sahibabad, ghaziabad, uttar pradesh
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
9958100191 |
| Fax |
|
| Email |
nidhi.sharma@ipdentalcollege.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajshree Verma |
| Designation |
student |
| Affiliation |
Inderprastha Dental College and Hospital |
| Address |
Department of Conservative Dentistry and Endodontics, P.G section, Room no 1, First Floor, 46/1, sahibabad industrial area site 4, sahibabad, ghaziabad, uttar pradesh
Department of Conservative Dentistry and Endodontics, P.G section, Room no 1, First Floor, 46/1, sahibabad industrial area site 4, sahibabad, ghaziabad, uttar pradesh
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
8800439626 |
| Fax |
|
| Email |
rajshreeverma221196@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr. Rajshree Verma |
| Address |
B-406, vasundhara valley appartments, sec-6, vasundhara, ghaziabad, uttar pradesh- 201012 |
| 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 Rajshree Verma |
Inderprastha Dental college and Hospital |
Department of Conservative dentistry and endodontics, P.G section, Room no. 1, First floor, 46/1. sahibabad industrial area site 4, sahibabad, ghaziabad, uttar pradesh 201010
Ghaziabad
UTTAR PRADESH |
8800439626
rajshreeverma221196@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ethical committee approval of inderprastha dental 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 |
| Intervention |
Calcicur |
Calcicur (Voco GmbH, Cuxhaven, Germany) is a ready to-use radiopaque water-based calcium hydroxide paste. It contains 45% calcium hydroxide and exhibits a high alkalizing pH correlating positively with the Ca (OH)2 mass fraction contained in it . Calcicur has a pH value 12.5 that imparts antimicrobial effect to the material. The quick setting time makes it easier to manipulate with and it can be placed with ease into the pulp cavity. Study duration is 3 months |
| Intervention |
dycal |
Dycal is a brand name for a dental calcium hydroxide liner, a two-component, rigid-setting, self-curing material used in dentistry for pulp capping and as a protective liner. It is commonly used to protect the pulp from irritants and bacterial invasion, and to promote healing and recovery of the pulp. Study duration is 3 months |
| Intervention |
Theracal LC |
Theracal LC is light curable, and needs no conditioning of the dentin surface to bond to. It can easily be bonded to various kinds of adhesive after application. Calcicur is application friendly and its consistency makes it a good choice for pulp capping. Study duration is 3 months
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Medically uncompromised adults
2. Adults aged between 18-50 years, who will give written consent to be a part of the study
3. Patients having permanent molars diagnosed with Symptomatic Irreversible Pulpitis
4. Sufficient coronal structure for adequate isolation
|
|
| ExclusionCriteria |
| Details |
1. Patients who will not give informed consent
2. Medically compromised patients
3. Periodontally compromised teeth
4. Teeth with any periapical lesion
5. Teeth with internal/external resorption
6. Teeth with calcifications
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| resolution of any signs or symptoms of symptomatic irreversible pulpitis |
1 week, 1 month, 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| no differences in the periapical area of the tooth under study |
1 week, 1 month, 3 months |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/06/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
clinical trial aims to evaluate the impact of different lining materials (Dycal, Theracal LC, Calcicur) on the success of full pulpotomy in permanent molars diagnosed with symptomatic irreversible pulpitis. Traditional root canal treatments are invasive and can weaken teeth, whereas full pulpotomy offers a minimally invasive alternative that preserves pulp vitality. Sixty-six patients aged 18–50 will be enrolled, with treatment success assessed clinically and radiographically at intervals over three months. Ethical clearance has been obtained, and informed consent procedures are in place. The study seeks to determine whether different materials affect outcomes significantly, using statistical analyses like Chi-Square tests and Cohen’s Kappa for reliability. |