| CTRI Number |
CTRI/2024/05/067685 [Registered on: 20/05/2024] Trial Registered Prospectively |
| Last Modified On: |
20/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of two activation techniques in primary Endodontic infections |
|
Scientific Title of Study
|
Comparative evaluation of Antimicrobial efficacy of Photoactivated Disinfection and Ultrasonic Activated Irrigation 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 Monika Tandan |
| Designation |
Professor |
| Affiliation |
Manav Rachna Dental College |
| Address |
Department of Conservative Dentistry and Endodontics
Manav Rachna Dental College
Surajkund Road
Faridabad
Surajkund Road
Faridabad
Faridabad
HARYANA
121004
India |
| Phone |
9999063631 |
| Fax |
|
| Email |
drmonikatandan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Monika Tandan |
| Designation |
Professor |
| Affiliation |
Manav Rachna Dental College |
| Address |
Department of Conservative Dentistry and Endodontics
Manav Rachna Dental College
Surajkund Road
Faridabad
Surajkund Road
Faridabad
Faridabad
HARYANA
121004
India |
| Phone |
9999063631 |
| Fax |
|
| Email |
drmonikatandan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Monika Tandan |
| Designation |
Professor |
| Affiliation |
Manav Rachna Dental College |
| Address |
Department of Conservative Dentistry and Endodontics
Manav Rachna Dental College
Surajkund Road
Faridabad
Surajkund Road
Faridabad
Faridabad
HARYANA
121004
India |
| Phone |
9999063631 |
| Fax |
|
| Email |
drmonikatandan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sudha Rustagi College of Dental Sciences and Research |
|
|
Primary Sponsor
|
| Name |
Sudha Rustagi College of Dental Sciences and Research |
| Address |
Kheri More
Village Bhopani
Faridabad |
| Type of Sponsor |
Private medical college |
|
|
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 Monika Tandan |
Sudha Rustagi College of Dental Sciences and Research |
Room No 7
Department of Conservative Dentistry and Endodontics
Faridabad
HARYANA |
9999063631
drmonikatandan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics 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 |
| Comparator Agent |
Photo activated Disinfection |
Canals will be irrigated with 10ml of 2.5% NaOCl. Canals will be filled with 0.01% toluidine blue photosensitiser and stirred with #10K file to avoid bubbles. Endo light tip will be inserted into the canal & irradiated for 30sec with Fotosan 630. |
| Intervention |
Ultrasonic activation |
The Canals will be irrigated with 5ml of 2.5% NaOCl solution and passively activated with ultrasonics in two planes simultaneously, i.e., for 20 seconds in the buccolingual direction and another 20 seconds in the mesiodistal direction of the root canal, 2 mm short of the working length. total time duration of 40 seconds |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients with non contributory history
Permanent teeth without previous restoration
Teeth with necrotic or infected pulp as diagnosed clinically and radiographically
Teeth having adequate coronal structure for proper isolation, temporisation and restoration |
|
| ExclusionCriteria |
| Details |
Patients on antibiotic therapy in last three months
Pregnant Women
periodical abscess
Pretreatment cases
calcified canals
sinus opening
immature apex
internal and external resorption
periodontal pockets greater than 5 mm |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Microbial count reduction after irrigant activation |
Pre treatment sample and post chemo mechanical preparation sample at baseline and after 1 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| percentage of microbial reduction |
Pre treatment sample & post chemo mechanical preparation sample at baseline & after 1 hour |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="45" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
30/05/2024 |
| Date of Study Completion (India) |
19/09/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Primary Endodontic infections are caused by microbial infection of the pulp and periapical tissues. Complete healing of the disease depends upon the elimination of micro-organism and their byproducts from the root canal system. Due to canal complexities, it is difficult to eradicate the infection through instrumentation once. Irrigation plays a vital role in disinfection of the root canal system. the irritant activation using various techniques have shown to improve irritant penetration and efficacy in several in vitro studies. This randomised controlled trial will be undertaken to evaluate the antimicrobial efficacy of two different activation techniques on microbial reduction in primary Endodontic infections. |