| CTRI Number |
CTRI/2026/02/103911 [Registered on: 16/02/2026] Trial Registered Prospectively |
| Last Modified On: |
11/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study on the use of Nigella sativa(Black seed) solution for cleaning root canals in people with diabetes |
|
Scientific Title of Study
|
Antimicrobial effectiveness of Nigella sativa as final root canal irrigant among patients with Type II Diabetes mellitus-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 Abdul Khader Shibah |
| Designation |
PG Student |
| Affiliation |
K V G Dental College and Hospital |
| Address |
Room 6 Department of conservative dentistry and endodontics K V G Dental College and Hospital Kurunjibagh Sullia Dakshina Kannada
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
8904218131 |
| Fax |
|
| Email |
a.kshibah142@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Moksha Nayak |
| Designation |
Professor and Principal |
| Affiliation |
K V G Dental College and Hospital |
| Address |
Room 6 Department of conservative dentistry and endodontics K V G Dental College and Hospital Kurunjibagh Sullia Dakshina Kannada
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
9448026828 |
| Fax |
|
| Email |
moksha.nayak@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abdul Khader Shibah |
| Designation |
PG Student |
| Affiliation |
K V G Dental College and Hospital |
| Address |
Room 6 Department of conservative dentistry and endodontics K V G Dental College and Hospital Kurunjibagh Sullia Dakshina Kannada
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
8904218131 |
| Fax |
|
| Email |
a.kshibah142@gmail.com |
|
|
Source of Monetary or Material Support
|
| K V G Dental College and Hospital Kurunjibhag sullia Dakshina Kannada Karnataka 574327 |
|
|
Primary Sponsor
|
| Name |
Abdul Khader Shibah |
| Address |
K V G Dental College and Hospital Kurunjibhag sullia Dakshina Kannada Karnataka 574327 |
| 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 Abdul Khader Shibah |
K V G Dental College and Hospital |
Room no 6 Department of Conservative Dentistry and Endodontics Kurunjibhag Sullia Dakshina Kannada Karnataka
Dakshina Kannada
KARNATAKA |
8904218131
a.kshibah142@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee K V G Dental College andHospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nigella sativa |
Nigella sativa solution will be used as the final root canal irrigant for 5 minutes during a single root canal treatment visit in patients with Type 2 diabetes having irreversible pulpitis with apical periodontitis |
| Comparator Agent |
Saline |
Saline solution will be used as the final root canal irrigant for 5 minutes during a single root canal treatment visit in patients with Type 2 diabetes having irreversible pulpitis with apical periodontitis |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Type II Diabetic patients of irreversible pulpitis with apical periodontitis in relation to posterior molar teeth |
|
| ExclusionCriteria |
| Details |
Teeth with root fracture
Teeth with developmental defects
Teeth with calcified canal
Teeth that cannot be isolated with rubber dam |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quantitative assessment of bacterial load from infected root canals of infected root canals of Type II diabetic patients with a diagnosis of irreversible pulpitis with apical periodontitis before and after the intervention in both the groups |
1 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To correlate clinical signs and symptoms with bacterial load before and after the interventions in both the groups |
1 day |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
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 4 |
|
Date of First Enrollment (India)
|
20/03/2026 |
| 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="0"
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 randomized controlled clinical trial aims to evaluate the antimicrobial effectiveness of Nigella sativa as a final root canal irrigant in patients with Type II diabetes mellitus diagnosed with irreversible pulpitis and apical periodontitis. Diabetic patients are more prone to persistent endodontic infections due to altered immune response and delayed healing. Conventional irrigants such as sodium hypochlorite, although effective, have limitations including cytotoxicity.
A total of 26 participants will be randomly allocated into two groups. The control group will receive conventional irrigation using 3% sodium hypochlorite and 17% EDTA followed by saline, while the experimental group will receive 3% sodium hypochlorite and 17% EDTA followed by Nigella sativa as the final irrigant. Microbiological samples will be collected before and after irrigation, and total bacterial load will be quantified using real-time PCR.
Clinical signs and symptoms will also be assessed before and after treatment. The study aims to determine whether Nigella sativa can serve as a safe and effective herbal alternative as a final root canal irrigant in diabetic patients |