| CTRI Number |
CTRI/2025/10/096399 [Registered on: 23/10/2025] Trial Registered Prospectively |
| Last Modified On: |
23/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
"Comparison of Herbal (Curcumin-Piperine-Lycopene) and Conventional (Calcium Hydroxide) Intracanal Medicaments for Pain Relief in Patients with Symptomatic Irreversible Pulpitis" |
|
Scientific Title of Study
|
Evaluation of safety and efficacy of Curcumin- Piperine- Lycopene combination versus Calcium Hydroxide as Intracanal Medicaments on pain relief in 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 Krishna Prasad Biswas |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Guwahati |
| Address |
Room NO 2007 Department of Dentistry All India Institute of Medical Sciences AIIMS Guwahati Changsari Kamrup Assam
Kamrup
ASSAM
781101
India |
| Phone |
918248137383 |
| Fax |
|
| Email |
krishnabiswas@aiimsguwahati.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajay Chhabra |
| Designation |
Associate Dean Research |
| Affiliation |
AIIMS Kalyani |
| Address |
Department of Dentistry, AIIMS Kalyani Saguna , NH 34 Connector Basantpur West Bengal
Nadia
WEST BENGAL
741245
India |
| Phone |
9417200001 |
| Fax |
|
| Email |
ajay.dental@aiimskalyani.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajay Chhabra |
| Designation |
Associate Dean Research |
| Affiliation |
AIIMS Kalyani |
| Address |
Department of Dentistry AIIMS Kalyani Saguna , NH 34 Connector Basantpur West Bengal
Nadia
WEST BENGAL
741245
India |
| Phone |
9417200001 |
| Fax |
|
| Email |
ajay.dental@aiimskalyani.edu.in |
|
|
Source of Monetary or Material Support
|
| AIIMS GUwahati Changsari Kamrup Assam 781101 India |
|
|
Primary Sponsor
|
| Name |
Dr Krishna prasad Biswas |
| Address |
AIIMS Guwahati Changsari Kamrup Assam 781101 |
| 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 Krishna Prasad Biswas |
AIIMS Guwahati |
Room no 2006, Department of Dentistry All India Institute of Medical Institute AIIMS Guwahati Changsari Kamrup Assam
Kamrup
ASSAM |
8248137383
krishnabiswas@aiimsguwahati.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RESEARCH REVIEW BOARD (RRB) & INSTITUTE ETHICS COMMITTEE (IEC) (HUMAN STUDIES) Version 1.0 |
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 |
Calcium Hydroxide |
As intracanal medicament for 7 days |
| Intervention |
curcoos |
curcumin 500mg piperine 5mg lycopene 10 mg as intracanal medicament for 7 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
i. Patient visiting Out Patient Department at AIIMS Guwahati
ii. Patient aged 18 -65 in good health and absence of disease
iii. Single rooted maxillary and mandibular teeth with irreversible pulpitis
iv.Informed Consent
|
|
| ExclusionCriteria |
| Details |
i. Failure to give consent
ii. Medically comprised
iii. Pregnant patient
iv. More than 1 root canal in tooth
v. Teeth with Periapical radiolucency
vi Had taken medication within 12 hrs of study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The curcumin-based group is expected to show a statistically significant reduction in inter-appointment pain and tenderness better or comparable outcome to traditional agents like calcium hydroxide .
The study anticipates fewer analgesic requirements
With better healing and recovery, prognosis of root canal treated teeth will be improved.
|
1st day 3rd day 5th day 7th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 |
|
Date of First Enrollment (India)
|
17/11/2025 |
| 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="6"
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
|
This study is randomized double blind parallel group trial comparing the safety and efficacy of Curcumin 500 mg, Piperine 5 mg, Lycopene 10 mg combination and Calcium Hydroxide as intracanal medicament for 7 days in 60 patients with symptomatic irreversible pulpitis that will be conducted in AIIMS Guwahati. The primary outcome likely that Curcumin based combination is expected to show a statistically significant reduction in inter-appointment pain and tenderness better or comparable to calcium hydroxide measured at 1st, 3rd, 5th and 7th day. |