| CTRI Number |
CTRI/2024/06/068447 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
16/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparison of the Property Against the Micro-organisms in the Root Canal, between Octenidine Dihydrochloride Chlorhexidine and Sodium Hypochlorite as Irrigating solutions: A Randomized Controlled Trial |
|
Scientific Title of Study
|
A Comparative Evaluation of Antimicrobial Efficacy of Octenidine Dihydrochloride with Chlorhexidine and Sodium Hypochlorite as Root Canal Irrigants: 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 |
Sahil Ali |
| Designation |
MDS Post Graduate Trainee |
| Affiliation |
Guru Nanak Institute of Dental Sciences and Research |
| Address |
Department of Conservative Dentistry and Endodontics, 2nd floor, Guru Nanak Institute of Dental Sciences and Research, 157/F, Nilgunj Road, Sahid Colony, Panihati
Kolkata
WEST BENGAL
700114
India
North Twentyfour Parganas
WEST BENGAL
700114
India |
| Phone |
7908532563 |
| Fax |
|
| Email |
sahilali.17.05.1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priti D Desai |
| Designation |
Professor, Department of Conservative Dentistry and Endodontics |
| Affiliation |
Guru Nanak Institute of Dental Sciences and Research |
| Address |
Department of Conservative Dentistry and Endodontics, 2nd floor, Guru Nanak Institute of Dental Sciences and Research, 157/F, Nilgunj Road, Sahid Colony, Panihati
Kolkata
WEST BENGAL
700114
India
North Twentyfour Parganas
WEST BENGAL
700114
India |
| Phone |
9831071632 |
| Fax |
|
| Email |
priti.desai@gnidsr.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Sahil Ali |
| Designation |
MDS Post Graduate Trainee |
| Affiliation |
Guru Nanak Institute of Dental Sciences and Research |
| Address |
Department of Conservative Dentistry and Endodontics, 2nd floor, Guru Nanak Institute of Dental Sciences and Research, 157/F, Nilgunj Road, Sahid Colony, Panihati
Kolkata
WEST BENGAL
700114
India
North Twentyfour Parganas
WEST BENGAL
700114
India |
| Phone |
7908532563 |
| Fax |
|
| Email |
sahilali.17.05.1996@gmail.com |
|
|
Source of Monetary or Material Support
|
| Guru Nanak Institute of Dental Sciences and Research, 157/F Nilgunj Road, Sahid Colony, Panihati, Kolkata- 700114 |
|
|
Primary Sponsor
|
| Name |
Guru Nanak Institute of Dental Sciences and Research |
| Address |
157/F Nilgunj Road, Sahid Colony, Panihati, Kolkata-700114 India |
| 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 |
| Dr Sahil Ali |
Guru Nanak Institute of Dental Sciences and Research |
Department of Conservative Dentistry and Endodontics, 2nd floor, PG Division, 157/F Nilgunj Road, Sahid Colony, Panihati, Kolkata-700114, West Bengal India
North Twentyfour Parganas
WEST BENGAL |
7908532563
sahilali.17.05.1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Reporting to the outpatient department with symptomatic irreversible pulpitis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1. Octenidine Dihydrochloride
2. Sodium Hypochlorite
3. Chlorhexidine Digluconate |
1.0.1% Octenidine Dihydrochloride is an antimicrobial agent, used as a irrigating solution during non surgical endodontic treatment.
2. 2.5% Sodium Hypochlorite, a potent antimicrobial agent against both gram positive and negative microorganisms.
3. 2% Chlorhexidine Digluconate, having substantivity. It is both bactericidal and bacteriostatic at different concentrations.
Delivery method- 27 gauge side vented syringe
2ml in between instrumentation |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients without any systemic disease
2. Tooth with fully formed root
3. Tooth diagnosed with systemic irreversible
pulpitis
4. Tooth which does not show tenderness on
percussion
5. Tooth with no periapical lesion |
|
| ExclusionCriteria |
| Details |
1. Patient with systemic disease and co-morbidities
2. Patient with history of medication(antibiotics) 15 days prior to the procedure
3. Tooth with history of previous endodontic treatment
4. Multirooted tooth
5.Non vital tooth
6. Tooth with root caries
7. Tooth with open apex
8. Tooth showing root resorption
9. Tooth with periapical lesion |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Antimicrobial efficacy of Octenidine Dihydrochloride (0.1%) compared to Sodium hypochlorite (2.5%) and Chlorhexidine Digluconate (2%) as a root canal irrigant |
Antimicrobial efficacy of Octenidine Dihydrochloride (0.1%) compared to Sodium hypochlorite (2.5%) and Chlorhexidine Digluconate (2%) as a root canal irrigant at baseline, immediately before the chemomechanical preparation and 1 hour after the chemomechanical preparation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Antimicrobial efficacy of 2.5% Sodium hypochlorite & 2% Chlorhexidine Digluconate |
Antimicrobial efficacy of 2.5% Sodium hypochlorite & 2% Chlorhexidine Digluconate at baseline immediately before the chemomechanical preparation & 1 hour after the chemomechanical preparation |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
11/06/2024 |
| Date of Study Completion (India) |
11/01/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
11/01/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
AIM OF THE STUDY To evaluate and compare the antimicrobial efficacy of 0.1% Octenidine Dihydrochloride compared to 2.5% Sodium Hypochlorite and 2% Chlorhexidine Digluconate as root canal irrigant. MATERIAL AND METHODS The study is designed as a prospective, randomized, double blinded clinical trial. 60 patients will be enrolled from the department of Conservative Dentistry and Endodontics who are systemically healthy between the age 15-40 years and fulfilling the inclusion criteria of the study. Patients will be randomly assigned into three groups using systemic random sampling technique. Group 1: 0.1% Octenidine Dihydrochloride Group 2: 2% Chlorhexidine Digluconate Group 3: 2.5% Sodium Hypochlorite Patients and outcome assessor will be blinded to the groups of the study. Chemo-mechanical preparation will be done till F2 Protaper Gold rotary file. And irrigation will be done using three different solutions according to the groups. Then bacterial samples will be collected using paper points before and after the instrumentation. Then Colony forming count will be done to evaluate the efficacy of the different solutions. |