| CTRI Number |
CTRI/2021/03/032049 [Registered on: 16/03/2021] Trial Registered Prospectively |
| Last Modified On: |
20/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of microbial colony count of commercially available herbal products with and without ultrasonic activation for disinfection of root canals in patients. |
|
Scientific Title of Study
|
Antimicrobial Efficacy of Two Commercially Available Herbal products with and without Ultrasonic activation in Primary Endodontic Infections - An In-Vivo study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Drishti Palwankar |
| Designation |
Post Graduate Student |
| Affiliation |
Sudha Rustagi College of Dental Sciences and Research |
| Address |
Department of Conservative Dentistry and Endodontics, Sudha Rustagi college of Dental Sciences and Research, Sector-89, Kheri More, Greater Faridabad, Haryana.
Faridabad
HARYANA
121002
India |
| Phone |
8447570200 |
| Fax |
|
| Email |
drishti212@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashima |
| Designation |
Professor |
| Affiliation |
Sudha Rustagi college of Dental Sciences and Research |
| Address |
Department of Conservative Dentistry and Endodontics, Sudha Rustagi college of Dental Sciences and Research, Sector-89, Kheri More, Greater Faridabad, Haryana.
Faridabad
HARYANA
121002
India |
| Phone |
9971444100 |
| Fax |
|
| Email |
drashimasood@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Drishti Palwankar |
| Designation |
Post Graduate Student |
| Affiliation |
Sudha Rustagi College of Dental Sciences and Research |
| Address |
Department of Conservative Dentistry and Endodontics, Sudha Rustagi college of Dental Sciences and Research, Sector-89, Kheri More, Greater Faridabad, Haryana.
Faridabad
HARYANA
121002
India |
| Phone |
8447570200 |
| Fax |
|
| Email |
drishti212@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Drishti Palwankar, Post-graduate student, Department of conservative dentistry and endodontics, Sudha Rustagi College of Dental Sciences and Research, sector-89, Kheri More, Greater Faridabad-121002, Haryana. |
|
|
Primary Sponsor
|
| Name |
Dr Drishti Palwankar |
| Address |
Sudha Rustagi College of Dental Sciences and Research, sector-89, Kheri More, Greater Faridabad-121002, Haryana. |
| 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 Drishti Palwankar |
Sudha rustagi college of dental sciences and research |
Room no.7, second floor, department of conservative dentistry and endodontics, sec-89, kheri more
Faridabad
HARYANA |
8447570200
drishti212@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sudha Rustagi college of Dental Sciences and Research |
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 |
| Comparator Agent |
2.5% Sodium Hypochlorite solution |
After bio-mechamical preparation, the root canal will be irrigated with 2.5% Sodium hypochlorite solution. Microbiological samples will be collected. |
| Comparator Agent |
2.5% Sodium hypochlorite solution with Ultrasonic activation |
After bio-mechanical prepration the root canal will be irrigated and passively activated by ultrasonics. Microbiological samples will be collected. |
| Intervention |
Neem juice with ultrasonic activation, Bitter gourd juice with Ultrasonic activation. |
After bio-mechanical preparation, the canals will be irrigated and passively activated by ultrasonics. Microbiological samples will be collected. |
| Intervention |
Neem juice, Bitter Gourd juice |
After bio-mechanical preparation, the root canals will be irrigated with neem juice and bitter gourd juice. Microbiolgical samples with sterile paper points will be collected. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients with non-contributory medical history, permanent teeth with necrotic or infected pulp as diagnosed clinically and radiographically with adequate coronal structure for proper isolation, temporization, and restoration will be included.
|
|
| ExclusionCriteria |
| Details |
Patients with systemic conditions, pregnant patients, acute periapical abscess, retreatment cases, patients on antibiotic therapy within three months, teeth with calcified canals, presence of intraoral or extra-oral sinus, immature apex, internal and external resorption and periodontal pockets >5 mm will be excluded. |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare and evaluate the antimicrobial efficacy of commercially available Neem (Azadirachta indica), Bitter gourd (Momordica charantia) and Sodium hypochlorite with and without ultrasonic activation in primary endodontic infections. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison in reduction of bacterial count at two stages- before biomechanical preparation (S1) and after biomechanical preparation (S2) of each sample |
45 minutes |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/03/2021 |
| Date of Study Completion (India) |
01/02/2022 |
| 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
Modification(s)
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
After following the inclusion and exclusion criteria, patients would be divided among six groups and bacterial counts will be estimated before and after the biomechanical preparation of root canals. The obtained colony counts will be compared to check the efficacy of Neem juice and Bitter gourd juice with and without ultrasonic activation against primary Endodontics infections. |