| CTRI Number |
CTRI/2025/11/097136 [Registered on: 10/11/2025] Trial Registered Prospectively |
| Last Modified On: |
09/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Post-treatment Pain After Cleaning Root Canals Using Two Different Modern Dental File Systems: A Randomized Study |
|
Scientific Title of Study
|
Postoperative Pain Following
Glide Path Preparation Using
Two NiTi File Systems in
Optimum Glide Path 2 (OGP 2) Motion:
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 Aswathy Suresh Kumar |
| Designation |
Postgraduate student |
| Affiliation |
Goa Dental College and Hospital |
| Address |
Pg Clinic,Department of Conservative Dentistry and Endodontics (Department No.6), Goa Dental College and Hospital,Edapally- Panvel Highway,Bambolim 403202
North Goa
GOA
403202
India |
| Phone |
08208736544 |
| Fax |
|
| Email |
aswathy2199@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Marina Fernandes |
| Designation |
Professor |
| Affiliation |
Goa Dental College and Hospital |
| Address |
Pg Clinic,Department of Conservative Dentistry and Endodontics (Department No.6), Goa Dental College and Hospital,Edapally- Panvel Highway,Bambolim 403202
North Goa
GOA
403202
India |
| Phone |
9049666453 |
| Fax |
|
| Email |
docrmarina@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aswathy Suresh Kumar |
| Designation |
Postgraduate student |
| Affiliation |
Goa Dental College and Hospital |
| Address |
Pg Clinic,Department of Conservative Dentistry and Endodontics (Department No.6), Goa Dental College and Hospital,Edapally- Panvel Highway,Bambolim 403202
North Goa
GOA
403202
India |
| Phone |
08208736544 |
| Fax |
|
| Email |
aswathy2199@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pg Clinic,Department of Conservative Dentistry and Endodontics (Department No.6), Goa Dental College and Hospital,Edapally- Panvel Highway,Bambolim 403202 |
|
|
Primary Sponsor
|
| Name |
Goa Dental College and Hospital, |
| Address |
Bambolim, Goa |
| Type of Sponsor |
Government 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 Aswathy Kumar |
Goa Dental College and Hospital |
Pg Clinic,Department of Conservative Dentistry and Endodontics (Department No.6), Edapally- Panvel Highway,Bambolim 403202
North Goa
GOA |
08208736544
aswathy2199@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Goa Dental College and Hospital 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 |
| Intervention |
NiTi File Proglider file used in Optimum Glide Path 2 (OGP 2) motion |
Glide path preparation performed using Proglider fileoperated in Optimum Glide Path 2 (OGP 2) motion according to manufacturer’s instructions. Root canal cleaning and shaping followed by standard obturation and postoperative pain assessment at 6, 12, 24, and 48 hours using a Visual Analogue Scale (VAS). |
| Comparator Agent |
NiTi File VDW Rotate used in Optimum Glide Path 2 (OGP 2) motion |
Glide path preparation performed using VDW Rotate operated in Optimum Glide Path 2 (OGP 2) motion according to manufacturer’s instructions. Subsequent steps and postoperative pain assessment identical to intervention group. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Clinical inclusion criteria
2.No Medical History.
3.Only one tooth per subject included.
4.Asymptomatic maxillary and mandibular first or second molars with necrotic pulp periapical lesions.
Radiographic inclusion criteria
1.Carious lesion involving the pulp space.
2.Periapical rarefaction up to Periapical index score 3 (PAI score 1 to 3)
3.Normal radiographic appearance with healthy supporting tissues.
|
|
| ExclusionCriteria |
| Details |
1.If the #15K-file crossed the apex without resistance or the #08K-file could not reach the working length, the teeth were excluded from the analysis.
2.Presence of acute or chronic apical abscess, acute pain at presentation.
3.Presence of any systematic illness.
4.Presence of swelling, pathological mobility, or sinus tract.
5.History of use of antibiotics in the preceding 7 days.
6.History of allergy to local anaesthetics.
7.Presence of progressive periodontal disease.
8.Pregnant or lactating women.
9.Teeth with calcified, resorbed, or complex canal anatomy, vital pulp, previous endodontic treatment, or deemed unrestorable/severely damaged.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Postoperative pain (VAS 0–10) recorded at baseline, 6 hrs, 12 hrs, 24 hrs and 48 hours post-treatment.
|
Baseline: Immediately after treatment
6 hours post-treatment
12 hours post-treatment
24 hours post-treatment
48 hours post-treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Analgesic intake (Number of analgesic intake)
2. Flare-ups/abscess formation requiring intervention
3. Procedural mishaps (e.g., instrument separation, ledge)
|
Baseline: Immediately after treatment
6 hours post-treatment
12 hours post-treatment
24 hours post-treatment
48 hours post-treatment |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 4 |
|
Date of First Enrollment (India)
|
25/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/11/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="10" |
|
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
|
This randomized clinical trial aims to compare postoperative pain following root canal preparation using Proglider versus VDW Rotate in adults requiring endodontic treatment of multiple rooted teeth. A total of 40 participants will be randomly assigned to one of the two groups. Postoperative pain will be assessed using a visual analogue scale (VAS) immediately after treatment (baseline), and at 6, 12, 24, and 48 hours post-procedure. The study is participant- and outcome-assessor–blinded to reduce bias. |