| CTRI Number |
CTRI/2026/01/100993 [Registered on: 13/01/2026] Trial Registered Prospectively |
| Last Modified On: |
12/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
A study to compare how effectively different cleaning methods, including sound waves and light therapy, remove bacteria from root canals during dental treatment. |
|
Scientific Title of Study
|
Clinical Study To Evaluate Antimicrobial Efficacy Of Passive Ultrasonic Irrigation, Conventional Irrigation And Photodynamic Therapy In Root Canal Treatment |
| 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 Dilip Parmar |
| Designation |
Post Graduate Student |
| Affiliation |
Narsinhbhai Patel Dental College And Hospital,Sankalchand Patel University,Visnagar |
| Address |
S P Sahakar Vidyadham Ambaji Gandhinagar Link Road Near
Kamana circle Visnagar Gujarat
Room Number 5 Department Of Conservative Dentistry And
Endodontics
Mahesana
GUJARAT
384315
India |
| Phone |
8238318750 |
| Fax |
|
| Email |
dpparmar42354235@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kailash Attur |
| Designation |
Professor And Head |
| Affiliation |
Narsinhbhai Patel Dental College And Hospital,Sankalchand Patel University,Visnagar |
| Address |
Room No 5 Department of Conservative Dentistry And Endodontics
Narsinhbhai Patel Dental College And Hospital Sankalchand patel
university Visnagar Mehsana
Mahesana
GUJARAT
384315
India
Mahesana
GUJARAT
384315
India |
| Phone |
9727752499 |
| Fax |
|
| Email |
atturkailash@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kailash Attur |
| Designation |
Professor And Head |
| Affiliation |
Narsinhbhai Patel Dental College And Hospital,Sankalchand Patel University,Visnagar |
| Address |
Room No 5 Department of Conservative Dentistry And Endodontics
Narsinhbhai Patel Dental College And Hospital Sankalchand patel
university Visnagar Mehsana
Mahesana
GUJARAT
384315
India
Mahesana
GUJARAT
384315
India |
| Phone |
9727752499 |
| Fax |
|
| Email |
atturkailash@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of conservative dentistry and endodontics. Narsinhbhai Patel Dental
College and Hospital Dental school in Visnagar Gujarat |
|
|
Primary Sponsor
|
| Name |
Dr Dilip Parmar |
| Address |
Amargadh-1,(Bhichari), Near Lalpari Lake, Behind, H.N. Shukla College, Rajkot-360002 |
| Type of Sponsor |
Other [Self] |
|
|
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 Dilip Parmar |
Narsinhbhai Patel Dental College and Hospital |
Room No. 5
Department of
Conservative
Dentistry, Narsinhbhai
Patel Dental College
And Hospital Nootan Dental
College Visnagar
Mahesana
GUJARAT
Mahesana
GUJARAT |
8238318750
dpparmar42354235@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Narsinhbhai Patel Dental College Visnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patient Require Root Canal Treatment |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Evaluation Of Disinfection Of Root Canal |
With Different Irrigants And Different Irrigation Techniques |
| Comparator Agent |
With Using Conventional Irrigation, Passive Ultrasonic Irrigation And Photodynamic Therapy (PDT)t In Root Canal Treatment |
To Evaluate The Success Of Photodynamic Therapy (PDT)t Using Indocyanine Green In Root Canal Treatment |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients Within The Age Group Of 18-65 Years Including Male & Female Both.
Permanent Single Rooted Mature Tooth With Single Canal (Anterior And Premolar).
Teeth Without Previous Restoration And Sufficient Coronal Structure For Isolation
Temporization And Restoration.
Teeth With Necrotic Or Infected Pulp. |
|
| ExclusionCriteria |
| Details |
Teeth With Fracture Lines, Open Apex Or Crack.
Teeth With Periapical Abscess Or Cyst,
Weeping Canals.
Patients Requiring Antibiotic Premedication.
Patients Who Declined To Give Consent For The Procedure.
Teeth With Severe Canal Curvatures, Accessory Canals, Calcified Canals, Resorption (Internal
And External), And Periodontal Diseases Were Excluded. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Increase In Depth Of Disinfection Of Root Canal After Subjecting The Teeth To Phothodynamic (PDT)t Therapy With Indocyanine Green And Decreased In Bacterial Load After Biomechanical Preparation. |
Indocyanine green–mediated photodynamic therapy will be applied in root canals using a 1 W continuous laser in three 8-second intervals. Baseline (S1) and post-treatment (S2) bacterial samples will be collected, cultured on brain heart infusion agar, and incubated for 24 hours. Antimicrobial efficacy will be evaluated by comparing CFU counts and statistically analyzing the reduction in bacterial load. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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 2 |
|
Date of First Enrollment (India)
|
31/03/2026 |
| 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="1"
Months="0"
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
|
Total 40 Sample Will Be Participating And Will Be Divided Into 4 Group
Group 1: Sodium Hypochlorite Irrigation. Group 2: Sodium Hypochlorite With Passive Ultrasonic Irrigation (PUI) irrigation. Group 3: Sodium Hypochlorite Irrigation Followed By Photodynamic Therapy (PDT)t With Indocyanine Green. Group 4: Sodium Hypochlorite With (PUI) Irrigation Followed By (PDT)t With Indocyanine Green. |