| CTRI Number |
CTRI/2026/02/104621 [Registered on: 24/02/2026] Trial Registered Prospectively |
| Last Modified On: |
23/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Which root canal medicine (Bioceramic and calcium hydroxide) works better to reduce pain between visits |
|
Scientific Title of Study
|
Comparative Efficacy of Bioceramic and Calcium Hydroxide Intracanal Medicaments on Interappointment Pain Reduction in Primary Non-surgical Endodontic therapy of non-vital posterior teeth- 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 |
Dr NAYANA RAJ |
| Designation |
POSTGRADUATE STUDENT in MDS program (Conservative Dentistry and Endodontics |
| Affiliation |
Government Dental College Thiruvananthapuram |
| Address |
Government Dental College Thiruvananthapuram, Medical College Road, Chalakkuzhi, Thiruvananthapuram, Kerala, India
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9562299016 |
| Fax |
|
| Email |
nayana11798@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SREEJA J |
| Designation |
Professor (CAP) |
| Affiliation |
Government Dental College Thiruvananthapuram |
| Address |
Dept of Conservative Dentistry and Endodontics,Room no-252,Floor no.2,Government Dental College Thiruvananthapuram, Medical College Road, Chalakkuzhi, Thiruvananthapuram, Kerala, India
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9446551581 |
| Fax |
|
| Email |
drsreejamdas@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr BINU P |
| Designation |
Assistant Professor |
| Affiliation |
Government Dental College Thiruvananthapuram |
| Address |
Dept of Conservative Dentistry and Endodontics, Room no. -252, Floor no.-2,Government Dental College Thiruvananthapuram, Medical College Road, Chalakkuzhi, Thiruvananthapuram, Kerala, India
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9496548682 |
| Fax |
|
| Email |
drbinup@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College Thiruvananthapuram, Kerala, India Pin code - 695011 |
|
|
Primary Sponsor
|
| Name |
Dr NAYANA RAJ |
| Address |
Government Dental College Thiruvananthapuram, Medical college road, Chalakkuzhi, Thiruvananthapuram, Kerala, 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 Nayana Raj |
Hospital |
Dept of Conservative Dentistry and Endodontics, Room no.-252, Floor no.-2,Government Dental College Thiruvananthapuram, Medical College Road, Chalakkuzhi,Thiruvananthapuram PIN-695011
Thiruvananthapuram
KERALA |
9562299016
nayana11798@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government Dental College Thiruvananthapuram |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Permanent posterior teeth with clinical signs of pulp necrosis |
| Patients |
(1) ICD-10 Condition: K041||Necrosis of pulp, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bio C Temp, Angelus, Brazil |
Bioceramic intracanal medicament |
| Comparator Agent |
CalciCure, SafeEndo, India |
Calcium Hydroxide intracanal medicament |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Permanent posterior teeth with clinical signs of pulp necrosis
Permanent posterior teeth with PAI score greater than or equal to 3
Patients willing to provide informed consent |
|
| ExclusionCriteria |
| Details |
Patients showing positive response to pulp sensibility test
Patients with uncontrolled systemic disease, tooth mobility, root fractures,non restorable teeth,perforations,retreatment cases
patients who had taken analgesics and antibiotics within the last 4-8 hours of treatment |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain will be assessed using VAS score |
4 hours, 12 hours, 24 hours, 3rd day, 7th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients experiencing flare-ups will be assessed |
4 hours, 12 hours, 24 hours, 3rd day and 7th day |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
09/04/2026 |
| 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="6"
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 clinical trial is to study the comparative efficacy of Bioceramic and Calcium Hydroxide intracanal medicaments on interappointment pain reduction in primary non-surgical endodontic therapy of posterior non-vital teeth. Sample size includes 140 participants and the study will be conducted in Government Dental College Thiruvananthapuram with a time period of 18 months. All the expenses will be self-financed by the Principal investigator. Informed consent from the participants will be obtained and confidentiality will be ensured and maintained throughout the study. |