| CTRI Number |
CTRI/2021/09/036709 [Registered on: 21/09/2021] Trial Registered Prospectively |
| Last Modified On: |
01/08/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Evaluation of agitation methods of irrigation during endodontic procedure |
|
Scientific Title of Study
|
Microbiological evaluation of different agitation methods of irrigation during endodontic procedure – A Randomised Clinical Trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RUCHI VASHISHT |
| Designation |
Assistant Professor |
| Affiliation |
PGIMER,CHANDIGARH |
| Address |
ROOM NUMBER 101
ORAL HEALTH SCIENCE CENTRE
PGIMER
CHANDIGARH
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9779703932 |
| Fax |
|
| Email |
dr.ruchivashisht@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
RUCHI VASHISHT |
| Designation |
Assistant Professor |
| Affiliation |
PGIMER,CHANDIGARH |
| Address |
ROOM NUMBER 101
ORAL HEALTH SCIENCE CENTRE
PGIMER
CHANDIGARH
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9779703932 |
| Fax |
|
| Email |
dr.ruchivashisht@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
RUCHI VASHISHT |
| Designation |
Assistant Professor |
| Affiliation |
PGIMER,CHANDIGARH |
| Address |
ROOM NUMBER 101
ORAL HEALTH SCIENCE CENTRE
PGIMER
CHANDIGARH
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9779703932 |
| Fax |
|
| Email |
dr.ruchivashisht@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PGIMER CHANDIGARH |
| Address |
DR.RUCHI VASHISHT
ROOM NO : 101
ORAL HEALTH SCIENCE CENTRE
PGIMER
CHANDIGARH
160012 |
| Type of Sponsor |
Research institution |
|
|
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 |
| RUCHI VASHISHT |
PGIMER |
ROOM NUMBER 101
ORAL HEALTH SCIENCE CENTRE
PGIMER
CHANDIGARH
Chandigarh
CHANDIGARH |
9779703932
dr.ruchivashisht@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 |
| Healthy Human Volunteers |
BETWEEN AGE GROUP 18 -45YEARS
HAVING SINGLE ROOTED TOOTH INFECTION WITH CHRONIC APICAL PERIODONTITIS WITH OR WITHOUT PERIPAICAL LESIONS.
|
| Patients |
, (1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
conventional. |
irrigation with syringe USING 2.5ML OF SODIUM HYPOCHLORITE SLOUTION FOR FIVE MINUTES. |
| Comparator Agent |
sonic |
irrigation with sonic device.
2.5 ML OF SODIUM HYPOCHLORITE SOLUTION FOR 5 MINUTES. |
| Comparator Agent |
ultrasonic |
irrigation with ultrasonic device.2.5 ML OF SODIUM HYPOCHLORITE SOLUTION FOR 5 MINUTES |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient with single rooted tooth infection.
2.Chronic apical periodontitis with or without periapical pathology
|
|
| ExclusionCriteria |
| Details |
1. Retreatment cases
2. Medically compromised patients
3. Teeth with open apex,root resorption and perforation
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| compare the effectiveness of different agitation methods of irrigation during root canal procedure. |
one month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction of E.FAECALIS population during root canal procedure. |
one month |
|
|
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)
|
01/10/2021 |
| 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="3"
Days="18" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
AIM : Evaluate the effectiveness of recently introduced sonic and ultrasonic irrigation devices as compared to conventional irrigation in reduction of E.FACEALIS POPULATION .
OBJECTIVES : 1. Compare the effectiveness of different agitation methods of irrgation during root canal procedure.2 reduction of E.Facealis population during root canal procedure.
METHODLOGY IN BRIEF : Paitent selection : enrolloment _ 60
groups - 3 sample divided by block randomisation method group 1 - control group in which irrgation would be done with normal syringe method group 2 - in which irrigation would be done by sonic method group 3 - in which irrigation would be done by ultrasonic method.
microbial samples from canals would be taken by paper points prior to irrigation as well as after irrigation and compared.
|