| CTRI Number |
CTRI/2025/03/082539 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
18/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the Reduction in Microbial Load after using three different Irrigation Activation techniques to disinfect the Root Canals of teeth. |
|
Scientific Title of Study
|
Comparative Evaluation of three different techniques on reduction in Microbial Load after endodontic treatment A Randomized Controlled 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 |
Sayali Ukey |
| Designation |
Post Graduate Student |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Centre |
| Address |
Ranjeet Deshmukh Dental College and Research Centre, Hingna
Ranjeet Deshmukh Dental College and Research Centre, Hingna
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9552514958 |
| Fax |
|
| Email |
sayali.ukey@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Pratima Shenoi |
| Designation |
Head of the Department |
| Affiliation |
Department of Conservative Dentistry and Endodontics |
| Address |
Ranjeet Deshmukh Dental College and Research Centre, Hingna
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9822220506 |
| Fax |
|
| Email |
prshenoi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sayali Ukey |
| Designation |
Post Graduate Student |
| Affiliation |
Department of Conservatiove Dentistry and Endodontics |
| Address |
Ranjeet Deshmukh Dental College and Research Centre, Hingna
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9552514958 |
| Fax |
|
| Email |
sayali.ukey@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Conservative Dentistry and Endodontics, Ranjeet Deshmukh Dental College and Research Centre,Hingna, Nagpur, India - 440016 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [0] |
|
|
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 Sayali Ukey |
Ranjeet Deshmukh Dental College and Research Centre |
Room no. 311, Department of Conservative Dentistry and Endodontics
Nagpur
MAHARASHTRA |
9552514958
sayali.ukey@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ranjeet Deshmukh Dental College and Research Center, Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K045||Chronic apical periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional irrigation technique |
Irrigation activation using syringle |
| Intervention |
Randomised Controlled Trial |
The aim of the study is to assess the reduction in microbial load after irrigation activation with XP Endo Finisher files and Er:Cr:YSGG laser for 60 seconds |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Systemically healthy patients under the age group of 18-50 years with preoperative pain
2. Teeth with single root and single canal
3. Periodontal ligament region widening or peri-apical region radiolucency with a periapical index (PAI) score of 1
|
|
| ExclusionCriteria |
| Details |
1. Patients with any systemic diseases
2. Presence of sinus tract or periapical abscess
3. Teeth with calcified canals, root resorption, immature/open apex, or previous root canal treatment
4. Patients who had previously taken any medication for pain
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the reduction in microbial load after irrigation activation with XP Endo Finisher files.
2. To evaluate the reduction in microbial load after irrigation activation with Er:Cr:YSGG laser.
3. To compare the reduction in microbial load after irrigation with XP Endo Finisher files and Er:Cr:YSGG laser.
|
The no of CFU will be assessed as before and after the procedure. 24 hours.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| -Reduction in pain |
- 24 hours, 48 hours |
|
|
Target Sample Size
|
Total Sample Size="27"
Sample Size from India="27"
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)
|
29/03/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
The patients will be pooled from the OPD at the Department of Conservative Dentistry and Endodontics. 27 systemically healthy patients aged 18-50 with preoperative pain, single-rooted teeth, and radiographic evidence of periapical lesion will be enrolled and randomly divided into three groups of nine: Group I (Conventional Needle Irrigation), Group II (XP-Endo Finisher), Group III (Er:Cr:YSGG laser). Samples will be collected before and after irrigation. The procedure will begin with informed consent, pre-operative radiographs, and local anesthesia. After accessing the root canal, the working length will be determined and confirmed using digital radiographs. Sample (S1) will be collected after working length determination using absorbent points placed up to the full working length. Canals will then be prepared biomechanically using rotary files. 3 ml NaOCl will be activated with the three different irrigant activation systems with physiological saline and post-irrigation samples (S2) will be taken. The teeth will be temporized, and patients will be recalled after three days for obturation. The samples will be processed and colony-forming units (CFUs) will be determined. |