| CTRI Number |
CTRI/2023/07/055311 [Registered on: 18/07/2023] Trial Registered Prospectively |
| Last Modified On: |
20/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
one-visit versus two-visit root canal retreatment |
|
Scientific Title of Study
|
Comparative Evaluation of Microbial Reduction in One-Visit & Two-Visit Endodontic Revisionism: A Randomised 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 |
Sahil Choudhari |
| Designation |
Post Graduate Student |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Department of Conservative Dentistry and Endodontics, Clinic-21, 162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077
Chennai
TAMIL NADU
600077
India |
| Phone |
9790592542 |
| Fax |
|
| Email |
152106002.sdc@saveetha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sindhu Ramesh |
| Designation |
Professor |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Department of Conservative Dentistry and Endodontics, Clinic-21, 162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077
Chennai
TAMIL NADU
600077
India |
| Phone |
9840136543 |
| Fax |
|
| Email |
dean.acd@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Sahil Choudhari |
| Designation |
Post Graduate Student |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Department of Conservative Dentistry and Endodontics, Clinic-21, 162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077
TAMIL NADU
600077
India |
| Phone |
9790592542 |
| Fax |
|
| Email |
152106002.sdc@saveetha.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Dental College and Hospital |
|
|
Primary Sponsor
|
| Name |
Saveetha Dental College and Hospital |
| Address |
162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Sahil Choudhari |
Saveetha Dental College and Hospital |
Department of Conservative Dentistry and Endodontics, Clinic-21 162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077
Chennai
TAMIL NADU |
9790592542
152106002.sdc@saveetha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Dental College - Institutional Human Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Secondary Endodontic Infection |
| Patients |
(1) ICD-10 Condition: K049||Other and unspecified diseases ofpulp and periapical tissues, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
One-Visit Endodontic Retreatment |
The root canal retreatment will be completed in one visit with standard irrigation and obturation protocol on the same day. (2 hours procedure) |
| Comparator Agent |
Two-Visit Endodontic Retreatment |
The root canal retreatment will be completed in two visits with calcium hydroxide dressing after first visit. Patient will be recalled after one week and obturation will be completed using standard obturation protocol. (1 hour procedure per visit) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Single rooted single canal teeth with secondary Endodontic infection.
Periapical index score of 1 to 4 |
|
| ExclusionCriteria |
| Details |
COMPLICATING SYSTEMIC DISEASE (ASA 3-6)
HISTORY OF ANTIBIOTIC USAGE IN THE LAST 3 MONTHS
TEETH WITH A HISOTRY OF ROOT CANAL TREATMENT FROM LESS THAN 3 YEARS BACK IN TIME
TEETH IN WHICH RUBBER DAM ISOLATION IS NOT FEASIBLE
TEETH WITH IATROGENIC ERRORS (PERFORATION, LEDGE, TRANSPORTATON)
TEETH WITH INTRARADICULAR POSTS
TEETH WITH SINUS TRACT
PERIODONTAL POCKETS DEEPER THAN 4mm
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Microbial Load Reduction using PCR |
Baseline, 1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post Operative Pain Measurement using Heft Parker Scale |
Pre operative, 24 hours, 48 hours, 72 hours, 7 days |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
Final Enrollment numbers achieved (Total)= "46"
Final Enrollment numbers achieved (India)="46" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/08/2023 |
| Date of Study Completion (India) |
15/02/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
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 - NO
|
|
Brief Summary
|
One of the main goals of root canal therapy is to eliminate the infectious process by reducing the microbial content to levels compatible with the healing of periapical tissues. However, some microorganisms originally present in necrotic tissues may survive chemomechanical procedures or may be located in missed canals or uninstrumented areas of the root canal system. Persistent bacteria can either induce new inflammation in the periapical region or contribute to the perpetuation of the infectious process even after root canal filling. Nonsurgical root canal retreatment is usually the first treatment option to eliminate infection in root-filled teeth. In these cases, after removal of the filling material, root canal disinfection can be achieved by chemomechanical preparation immediately followed by obturation (1-visit treatment) or supplemented by a previous interappointment intracanal medication (2-visit treatment). |