| CTRI Number |
CTRI/2025/02/080671 [Registered on: 17/02/2025] Trial Registered Prospectively |
| Last Modified On: |
14/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of the Antimicrobial effect of three herbal irrigants in primary endodontic infections |
|
Scientific Title of Study
|
Comparitive Evaluation of The Antimicrobial Efficacy of Three Herbal Irrigants in Primary Endodontic Infections- A Randomized Clinical 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.Jhalak Talwar |
| Designation |
PG Student |
| Affiliation |
SGT Dental College,Hospital and Research Institute |
| Address |
Room no.204,Department of Conservative Dentistry and Endodontics,faculty of dental sciences,SGT University,Gurgaon Badli road, Haryana
UU-48 Pitampura,Vishakha Enclave,Near Gurudwara,Delhi-110034
Gurgaon
HARYANA
122505
India |
| Phone |
09968581171 |
| Fax |
|
| Email |
docjhalak@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Ankita Sharma |
| Designation |
Associate Professor |
| Affiliation |
SGT Dental College,Hospital and Research Institute |
| Address |
Room no.204,Department of Conservative Dentistry and Endodontics,Faculty of Dental Sciences,SGT Dental College Hospital and Research Institute, Gurgaon Badli road, Haryana
Gurgaon
HARYANA
122505
India |
| Phone |
9682575180 |
| Fax |
|
| Email |
as.ankita06@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Ankita Sharma |
| Designation |
Associate Professor |
| Affiliation |
SGT Dental College,Hospital and Research Institute |
| Address |
Room no.204,Department of Conservative Dentistry and Endodontics,Faculty of Dental Sciences,SGT Dental College Hospital and Research Institute, Gurgaon Badli road, Haryana
HARYANA
122505
India |
| Phone |
9682575180 |
| Fax |
|
| Email |
as.ankita06@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no.204,Department of Conservative Dentistry and Endodontics,Faculty of Dental Sciences,SGT Dental College Hospital and Research |
|
|
Primary Sponsor
|
| Name |
SGT University |
| Address |
Room no.204,Department of Conservative Dentistry and Endodontics,Faculty of Dental Sciences,SGT Dental College Hospital and Research |
| Type of Sponsor |
Research institution and hospital |
|
|
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 JHALAK |
SGT UNIVERSITY |
Room no.5,faculty of dental sciences,SGT University Gurgaon HARYANA
Gurgaon
HARYANA |
09968581171
docjhalak@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SGT UNIVERSITY ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K041||Necrosis of pulp, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Chitosan |
Pretreatment Sample will be obtained by injecting normal saline (5 ml) into the root canal and circumferentially pumping a #15 K-file. A sterile paper point will be inserted after immersing into the transport media and placed into the canal for 60 seconds. It will be then immediately transported to the Eppendorf tube containing transport media. Biomechanical preparation till and irrigation using 2mLof 2% Chitosan in primary endodontic infections, a sterile paper point will be inserted after immersing into the transport media and placed into the canal for 60 seconds. It will be then immediately transported to the Eppendorf tube containing transport media.Total duration will be 10 minutes. |
| Intervention |
Curcumin |
Pretreatment Sample will be obtained by injecting normal saline (5 ml) into the root canal and circumferentially pumping a #15 K-file. A sterile paper point will be inserted after immersing into the transport media and placed into the canal for 60 seconds. It will be then immediately transported to the Eppendorf tube containing transport media. Biomechanical preparation till and irrigation using 2mLof 95% curcumin in primary endodontic infections, a sterile paper point will be inserted after immersing into the transport media and placed into the canal for 60 seconds. It will be then immediately transported to the Eppendorf tube containing transport media.Total duration will be 10 minutes. |
| Intervention |
Propolis |
Pretreatment Sample will be obtained by injecting normal saline (5 ml) into the root canal and circumferentially pumping a #15 K-file. A sterile paper point will be inserted after immersing into the transport media and placed into the canal for 60 seconds. It will be then immediately transported to the Eppendorf tube containing transport media. Biomechanical preparation till and irrigation using 2mLof 11% propolis in primary endodontic infections, a sterile paper point will be inserted after immersing into the transport media and placed into the canal for 60 seconds. It will be then immediately transported to the Eppendorf tube containing transport media.Total duration will be 10 minutes. |
| Comparator Agent |
Sodium hypochlorite
|
Pretreatment Sample will be obtained by injecting normal saline (5 ml) into the root canal and circumferentially pumping a #15 K-file. A sterile paper point will be inserted after immersing into the transport media and placed into the canal for 60 seconds. It will be then immediately transported to the Eppendorf tube containing transport media. Biomechanical preparation till and irrigation using 2mLof 5.25% sodium hypochlorite in primary endodontic infections, a sterile paper point will be inserted after immersing into the transport media and placed into the canal for 60 seconds. It will be then immediately transported to the Eppendorf tube containing transport media.Total duration will be 10 minutes. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient aged 25-65 years.
Single rooted teeth with one canal.
Single rooted teeth with symptomatic apical periodontitis.
Single rooted teeth with irreversible pulpitis.
Teeth with necrotic pulp that will be confirmed by pulp sensitivity test. No previous history of endodontic treatment
Tooth should have enough coronal tooth structure for rubber dam placement. |
|
| ExclusionCriteria |
| Details |
Teeth with unrestorable tooth structure
Patients with poor periodontal status.(periodontal pockets 5 mm)
Patients with sinus tract, periapical abscess or intraoral swelling.
Retreatment cases
Presence of a difficult root canal anatomy such as dilaceration, calcified canals, immature apex, root resorption.
Patients who had received nsaids or antibiotic treatment in three months before the study.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare the antibacterial effectiveness of three herbal irrigants, propolis, chitosan and curcumin with sodium hypochlorite in the primary endodontic infections treated in two visit endodontic treatment.
|
Pre operative and immediately after irrigation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate & compare the antibacterial efficacy of the three herbal irrigants propolis, chitosan & curcumin with sodium hypochlorite, in the primary endodontic infections treated in two visit endodontic treatment.
|
Pre operative & immediately after irrigation |
|
|
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)
|
28/02/2025 |
| 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="0"
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 study will aim to evaluate the antibacterial efficacy of three herbal products (propolis, chitosan, and curcumin) as root canal irrigants in comparison to sodium hypochlorite. Sixty patients with primary endodontic infections will be randomly divided into four groups (n=15 each). Preoperative and post-instrumentation bacterial samples will be collected from each canal. Biomechanical preparation will be performed using rotary instruments. Samples will be cultured on Brain Heart Infusion agar, and bacterial colony counts will be determined. Data normality will be assessed using the Shapiro-Wilk test, and inter-group comparisons will be conducted using ANOVA followed by the Tukey post-hoc test to determine statistically significant differences in antibacterial activity between the irrigation solutions. |