| CTRI Number |
CTRI/2018/08/015545 [Registered on: 30/08/2018] Trial Registered Prospectively |
| Last Modified On: |
15/05/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To check the antimicrobial efficacy of two herbal products with sodium hypochlorite as root canal irrigant. |
|
Scientific Title of Study
|
Comparative evaluation of anitimicrobial efficacy of two herbal products as root canal irrigants 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 Sonam Dhall |
| Designation |
MDS Student |
| Affiliation |
|
| Address |
Sudha Rustogi College of Dental Science and Research , Sector - 89, Kheri More, Bhopani Village, Faridabad, Haryana
Faridabad
HARYANA
121002
India |
| Phone |
9958923049 |
| Fax |
|
| Email |
sonamdhall242@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rakesh Kumar |
| Designation |
Professor and Head of Department of Conservative Dentistry and Endodontics |
| Affiliation |
|
| Address |
Sudha Rustogi College of Dental Science and Research , Sector - 89, Kheri More, Bhopani Village, Faridabad, Haryana
Faridabad
HARYANA
121002
India |
| Phone |
|
| Fax |
|
| Email |
mttlrksh@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonam Dhall |
| Designation |
MDS Student |
| Affiliation |
|
| Address |
Sudha Rustogi College of Dental Science and Research , Sector - 89, Kheri More, Bhopani Village, Faridabad, Haryana
Faridabad
HARYANA
121002
India |
| Phone |
|
| Fax |
|
| Email |
sonamdhall242@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sudha Rustogi College of Dental Science and Research , Sector - 89, Kheri More, Bhopani Village, Faridabad, Haryana 121002 |
|
|
Primary Sponsor
|
| Name |
Dr Sonam Dhall |
| Address |
Sudha Rustogi College of Dental Science and Research , Sector - 89, Kheri More, Bhopani Village, Faridabad, Haryana 121002 |
| 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 Sonam Dhall |
Sudha Rustogi College of Dental Science and Research , Faridabad |
Room no. - 7 , second floor, department of conservative dentistry and endodontics, faridabad, haryana
Faridabad
HARYANA |
9958923049
sonamdhall242@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Pandit Bhagwat Dayal Sharma University of Health Sciences, Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
, , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Chitosan |
Root canals are irrigated with 5ml of chitosan after biomechanical preparation |
| Intervention |
Conventional endodontic irrigation |
root canals will be irrigated with 5ml of 2.5% NaOCL, 17% EDTA , saline |
| Comparator Agent |
Propolis |
Root canals are irrigated with 5ml of propolis after biomechanical preparation |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients with non-contributory medical history, intact permanent teeth without any previous restoration, teeth with necrotic or infected pulp as diagnosed clinically and radiographically, teeth with adequate coronal structure for proper isolation, temporization, and restoration will be included. |
|
| ExclusionCriteria |
| Details |
Patients with systemic conditions, acute periapical abscess, retreatment cases, patients on antibiotic therapy within three months, teeth with calcified canals, presence of intra or extra oral sinus, immature apex, internal or external resorption or periodontal pockets >5 mm will be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of two herbal products as root canal irrigants in primary endodontic infections by estimating reduction of bacterial counts |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| comparison of reduction of bacterial counts at two stages- S1(before BMP) and S2 (after BMP) of each sample |
45 minutes |
| to evaluate the efficacy of two herbal products- chitosan and propolis, as root canal irrigants in primary endodontic infections |
6 months |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
Final Enrollment numbers achieved (Total)= "66"
Final Enrollment numbers achieved (India)="66" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2018 |
| Date of Study Completion (India) |
10/05/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
10/05/2019 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
After following inclusion and exclusion criteria, patients would be divided among three groups and bacterial counts will be estimated before and after biomechnaical preparation of root canals. The obtained colony counts will be compared to check efficacy of two herbal products - CHITOSAN AND PROPOLIS in primary endodontic infections.
|