CTRI Number |
CTRI/2023/09/057727 [Registered on: 15/09/2023] Trial Registered Prospectively |
Last Modified On: |
07/07/2024 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Dentistry |
Study Design |
Non-randomized, Multiple Arm Trial |
Public Title of Study
|
A Clinical Study on Quantitative Analysis of Antibacterial Efficacy of Herbal Irrigants Against Endodontic Microflora |
Scientific Title of Study
|
Quantitative Analysis of Antibacterial Efficacy of Herbal Irrigants Against Endodontic Microflora – A Clinical Study |
Trial Acronym |
nil |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Lovely Das |
Designation |
MDS Post Graduate Trainee |
Affiliation |
Guru Nanak Institute of Dental Sciences and Research |
Address |
EF-10, 1620 Rajdanga Main Road, East Kolkata Township 157/F, Nilgunj Road, Sahid Colony, Panihati, Sodepur, Kolkata- 700114
Department of Conservative Dentistry and Endodontics (post graduate division) Kolkata WEST BENGAL 700107 India |
Phone |
08274863635 |
Fax |
|
Email |
drlovelydas@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Ipsita Maity |
Designation |
Professor |
Affiliation |
Guru Nanak Institute of Dental Sciences and Research |
Address |
Vivekananda Abasan, 94/25 Nayapatti Road, Shyamnagar, Kolkata 157/F, Nilgunj Road, Panihati, Kolkata-700114
Department of Conservative Dentistry and Endodontics Kolkata WEST BENGAL 700055 India |
Phone |
09051860156 |
Fax |
|
Email |
ipsita.maity@gnidsr.ac.in |
|
Details of Contact Person Public Query
|
Name |
Dr Lovely Das |
Designation |
MDS Post Graduate Trainee |
Affiliation |
Guru Nanak Institute of Dental Sciences and Research |
Address |
EF-10, 1620 Rajdanga Main Road, P.S- Kasba, Kolkata-700107 157/F, Nilgunj Road, Panihati, Kolkata-700114
Department of Conservative Dentistry and Endodontics (post graduate division) Kolkata WEST BENGAL 700107 India |
Phone |
09007162723 |
Fax |
|
Email |
drlovelydas@gmail.com |
|
Source of Monetary or Material Support
|
Guru Nanak Institute of Dental Sciences and Research |
Lovely Das |
|
Primary Sponsor
|
Name |
Lovely Das |
Address |
EF-10. 1620 Rajdanga Main Road, Kolkata - 700107 |
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 Lovely Das |
Guru Nanak IInstitute of Dental Sciences and Research |
157/F, Nilgunj Road, Sahid Colony, Panihati, Kolkata- 700114
Department of Conservative Dentistry and Endodontics (post graduate division)
Kolkata WEST BENGAL |
08274863635
drlovelydas@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Comittee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: K041||Necrosis of pulp, (2) ICD-10 Condition: 8||Other Procedures, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
3% Sodium Hypochlorite |
used as 5 ml solution after every instrumentation with sided vented needle during root canal treatment |
Intervention |
Alcoholic Neem Extract irrigating solution |
Alcoholic Neem Extract root canal irrigant used as 5 ml solution after every instrumentation with sided vented needle during root canal treatment |
Intervention |
Green tea 3.5% root canal irrigating solution |
Green tea 3.5% root canal irrigant used as 5 ml solution after every instrumentation with sided vented needle during root canal treatment |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
50.00 Year(s) |
Gender |
Both |
Details |
Pulpal necrosis tooth with Symptomatic apical periodontits or Asymptomatic apical periodontitis in Single / multirooted tooth ( in case of multirooted tooth the largest canal for posterior teeth)
|
|
ExclusionCriteria |
Details |
Wide/open apex
Re – treatment endodontic cases
Acute apical abscess
Periodontal disease (presence of pocket >4 mm)
Pregnant patient
Medically compromised patients
Calcified canal
Internal resorption cases
Patient who is on antibiotic medications for the last 3 months
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
1. To evaluate the efficacy of Neem solution against micro-organisms present in root canal.
2. To evaluate the efficacy of Green tea solution against micro-organisms present in root canal. |
Before & after using the designated solution |
|
Secondary Outcome
|
Outcome |
TimePoints |
1. To evaluate & compare the antimicrobial efficacy of Neem and Green tea solution.
2. To evaluate and compare the antimicrobial efficacy of Neem and Green tea solution with the Sodium hypochlorite.
|
Before & after using the designated solution in a span of 6 months to 1 year sample collection |
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="0" |
Phase of Trial
|
Phase 2/ Phase 3 |
Date of First Enrollment (India)
|
22/09/2023 |
Date of Study Completion (India) |
10/01/2024 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="0" Months="3" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
N/A |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drlovelydas@gmail.com].
- For how long will this data be available start date provided 01-09-2024 and end date provided 01-09-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
|
The main objectives of the non-surgical endodontic treatment are the elimination of micro-organisms from the root canal space and the prevention of reinfection. Chemomechamical preparation is considered to be one of the most important steps in the management of infected root canal system which includes proper instrumentation and meticulous irrigation. Ideally, an endodontic irrigant should have antimicrobial efficacy, tissue dissolving capacity along with nontoxic and biocompatible nature. Through the years, various irrigating solutions have been used in contemporary dentistry, however none of them has all the properties needed. So, a combined use of separate irrigants is recommended to ensure the successful outcome, which makes the procedure quite lengthy. Sodium hypochlorite (NaOCl), is a reducing agent, straw colored solution used majorly as the main root canal irrigant and responsible for antimicrobial action. On the basis of published data, a wide range of percentage of sodium hypochlorite can be used from 0.5% - 5.2%. nevertheless, it has some serious complications, some of which are life-threatening. It causes chemical burn on extrusion to the periapical area during root canal treatment. In higher concentration it causes hemolysis, ulceration, inhibition of neutrophil migration, damage to fibroblast cells, and necrosis on extrusion to surrounding tissue. Herbal irrigants are comparatively newer irrigant in the field of endodontics, focus on the owning of their advantages and minimal side effects. Neem and green tea are full of different flavonoids, catechins which antimicrobial and beneficial in various ways. Therefore, the aim of this study is to evaluate and compare the antimicrobial efficacy of these two herbal irrigants with most commonly used irrigant, sodium hypochlorite. |