| CTRI Number |
CTRI/2025/03/082768 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
11/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Comparative Assessment of three irrigation activation techniques on Postoperative pain after Root canal Treatment: a Randomized Controlled Trial.
|
|
Scientific Title of Study
|
Comparative assessment of three Irrigation Activation Techniques on Postoperative Pain 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 |
Dr shweta Rathi |
| Designation |
pg student |
| Affiliation |
VSPM DENTAL COLLEGE |
| Address |
311, Department of Conservative Dentistry and Endodontics.
VSPM Dental College and Research Centre,
Digdoh Hills, Hingna road
Nagpur 440019
Maharashtra India
Nagpur
MAHARASHTRA
440015
India |
| Phone |
9168065305 |
| Fax |
|
| Email |
shwetarathi16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pratima Shenoi |
| Designation |
HOD |
| Affiliation |
VSPM DENTAL COLLEGE |
| Address |
311, Department of Conservative Dentistry and Endodontics.
VSPM Dental College and Research Centre,
Digdoh Hills, Hingna road
Nagpur 440019
Maharashtra India
Nagpur
MAHARASHTRA
440015
India |
| Phone |
9822220506 |
| Fax |
|
| Email |
prshenoi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr shweta Rathi |
| Designation |
pg student |
| Affiliation |
VSPM DENTAL COLLEGE |
| Address |
311, Department of Conservative Dentistry and Endodontics.
VSPM Dental College and Research Centre,
Digdoh Hills, Hingna road
Nagpur 440019
Maharashtra India
Nagpur
MAHARASHTRA
440015
India |
| Phone |
9168065305 |
| Fax |
|
| Email |
shwetarathi16@gmail.com |
|
|
Source of Monetary or Material Support
|
| self
311, Department of Conservative Dentistry and Endodontics
Nagpur, Maharashtra, pincode 440019
India |
|
|
Primary Sponsor
|
| Name |
not applicable |
| Address |
not applicable |
| Type of Sponsor |
Other [no sponsor] |
|
|
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 Shweta Rathi |
VSPM DENTAL COLLEGE AND RESEARCH CENTRE |
311, Department of Conservative Dentistry and Endodontics
Nagpur
MAHARASHTRA |
9168065305
shwetarathi16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VSPM Dental College and Research Centre Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K044||Acute apical periodontitis of pulpal origin, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
not applicable |
not applicable |
| Intervention |
Randomized controlled trial |
3 ml of 3% sodium hypochlorite was used in each tooth, and three different irrigation activation techniques were used. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1 Teeth with single root and single canal
2 Absence of any osseous changes
3 Periodontal ligament region widening or periapical region radiolucency with a periapical index (PAI) score of 0-1
|
|
| ExclusionCriteria |
| Details |
1 Patients with any systemic diseases
2 Teeth of patients with a sinus tract and a periapical abscess
3 Teeth with calcified canals, root resorption, immature/open apex, or previous root canal treatment
|
|
|
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 |
| To Evaluate three different irrigation activation techniques on postoperative pain after endodontic treatment. |
baseline, 24 hours, 48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| no secondary outcome |
no secondary outcome |
|
|
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
31/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
31/03/2025 |
| 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 Yet Recruiting |
| 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
|
In this randomized controlled trial, 27 patients diagnosed with symptomatic irreversible pulpitis requiring root canal treatment for teeth with single root will be recruited from the opd . After access opening and biomechanical preparation, the patients will be randomly divided into the three groups based on the final irrigation protocol. 3 mL of 3% NaOCl will be dispensed into the canal and activated using following irrigation activation technique: GROUP I: Conventional irrigation method (control group) using 30G side vented needle. GROUP II: XP-Endo Finisher file. (experimental group) GROUP III: Laser Activated Irrigation. (experimental group) A 10 cm visual analogue scale (VAS) will be used for pain assessment. The pain scores will be assessed postoperatively after 24 and 48 h telephonically. |