| CTRI Number |
CTRI/2025/11/097666 [Registered on: 18/11/2025] Trial Registered Prospectively |
| Last Modified On: |
18/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative Evaluation of threee Herbal Intracanal Medicaments in human teeth with Calcium Hydroxide, on Inter-Appointment Endodontic Pain |
|
Scientific Title of Study
|
Comparative Assessment of Inter-appointment Endodontic Pain after using Calcium Hydroxide and three Herbal Intracanal Medicaments: A Randomized Controlled Clinical Trial |
| Trial Acronym |
Herbal Intracanal Medicaments |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dhwani Mehta |
| Designation |
Post graduate student |
| Affiliation |
College of Dental Science, Amargadh |
| Address |
202,Tathastu, plot-8 harinagar society, near Anand Vidya Vihar school, Gotri
Room No.4, Post-graduate Section, Department of Conservative Dentistry and Endodontics, College of Dental Science and Hospital, Amargadh
K J Mehta TB Hospital Trust
Amargadh
Taluka Shihor 364210
Bhavnagar
GUJARAT
390021
India |
| Phone |
09429870351 |
| Fax |
|
| Email |
dhwani.manan.mehta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepika C Mod |
| Designation |
Professor and head |
| Affiliation |
College Of Dental Science,Amargadh |
| Address |
Room No. 4, HOD, Department of Conservative Dentistry and Endodontics, College of Dental Science and Hospital, Amargadh
K J Mehta TB Hospital Trust
Amargadh
Taluka Shihor 364210
Room No. 4, HOD, Department of Conservative Dentistry and Endodontics, College of Dental Science and Hospital, Amargadh
K J Mehta TB Hospital Trust
Amargadh
Taluka Shihor 364210
Bhavnagar
GUJARAT
364210
India |
| Phone |
9426448030 |
| Fax |
|
| Email |
dr_deepika@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepika C Mod |
| Designation |
Professor and head |
| Affiliation |
College Of Dental Science,Amargadh |
| Address |
Room No. 4, HOD, Department of Conservative Dentistry and Endodontics, College of Dental Science and Hospital, Amargadh
K J Mehta TB Hospital Trust
Amargadh
Taluka Shihor 364210
Room No. 4, HOD, Department of Conservative Dentistry and Endodontics, College of Dental Science and Hospital, Amargadh
K J Mehta TB Hospital Trust
Amargadh
Taluka Shihor 364210
Bhavnagar
GUJARAT
364210
India |
| Phone |
9426448030 |
| Fax |
|
| Email |
dr_deepika@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Dhwani Mehta |
| Address |
202,Tathastu, plot-8 harinagar society, near Anand Vidya Vihar school, gotri 390021 |
| 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 Dhwani Mehta |
College of Dental Science |
Room No. 4, Post-graduate Section, Department of Conservative Dentistry and Endodontics, College of Dental Science and Hospital, Amargadh
K J Mehta TB Hospital Trust
Amargadh
Taluka Shihor 364210
Bhavnagar
GUJARAT |
09428201452
dhwani.manan.mehta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, College Of Dental Science, Amargadh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K045||Chronic apical periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Calcium Hydroxide Paste |
Intra Canal Medicament for 7 days |
| Intervention |
Curcumin paste |
Herbal Intra Canal Medicament for 7 days |
| Intervention |
Echinacea paste |
Herbal Intra Canal Medicament for 7 days |
| Intervention |
Morinda citrifolia paste |
Herbal Intra Canal Medicament for 7 days |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Single rooted maxillary and mandibular teeth.
Teeth showing clinical and radiographical signs of symptomatic irreversible pulpitis, pulp necrosis and apical periodontitis necesstiating endodontic treatment.
|
|
| ExclusionCriteria |
| Details |
Multi-rooted teeth.
Patients on any kind of medication/antibiotics/analgesics and drugs interferring with pain response.
Patient with history of allergic reaction to any intracanal medicaments.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Herbal intra canal medicaments are equally effective in reducing inter-appointment pain. |
For 7 days |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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)
|
02/12/2025 |
| 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="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
|
The most used intracanal medicament is Calcium Hydroxide which has antibacterial properties and has the ability to repair and stimulate hard tissue formation. Despite its efficacy, Calcium Hydroxide which is a synthetic material can cause negative effect on dentin making it more susceptible to fracture and may not be effective against all microbial changes, leading to persistent pain and treatment challenges. There are many herbal medicaments of which efficacy is seen and researched worldwide. Newer herbal medicaments like Curcumin, Echinacea, Morinda citrifolia have been known for antimicrobial and antiinflammatory action. Therefore, this study will be performed.
|