| CTRI Number |
CTRI/2025/06/088883 [Registered on: 16/06/2025] Trial Registered Prospectively |
| Last Modified On: |
15/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Efficacy of Sodium Hypochlorite, Chlorhexidine, Ozonated Olive Oil, and Diode Laser in Treating Irreversible Pulpitis |
|
Scientific Title of Study
|
Comparative Evaluation of Antimicrobial Efficacy of 5.25 percentage Sodium hypochlorite, 2 percentage Chlorhexidine, Ozonated Olive Oil and Diode laser In Irreversible Pulpitis Cases - 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 Akash Shailesh Thakare |
| Designation |
MDS 2nd year |
| Affiliation |
Sharad Pawar Dental College |
| Address |
Department of Conservative Dentistry and Endodontics, Sharad Pawar Dental College, Datta Meghe Institute of Higher Education and Research (DMIHER(DU)), Sawangi (Meghe), Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
09404373748 |
| Fax |
|
| Email |
akash_thakare93@outlook.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shweta Kishor Sedani |
| Designation |
Associate Professor |
| Affiliation |
Sharad Pawar Dental College |
| Address |
Department of Conservative Dentistry and Endodontics, Sharad Pawar Dental College and Hospital, Datta Meghe Institute of Higher Education and Research (DMIHER(DU)), Sawangi (Meghe), Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9561468222 |
| Fax |
|
| Email |
doc.shwets@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akash Shailesh Thakare |
| Designation |
MDS 2nd year |
| Affiliation |
Sharad Pawar Dental College |
| Address |
Department of Conservative Dentistry and Endodontics, Sharad Pawar Dental College, Datta Meghe Institute of Higher Education and Research (DMIHER(DU)), Sawangi (Meghe), Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
09404373748 |
| Fax |
|
| Email |
akash_thakare93@outlook.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Akash Shailesh Thakare |
Sharad Pawar Dental College |
103, Department of Conservative Dentistry and Endodontics, Sawangi Meghe, Wardha
Wardha
MAHARASHTRA |
09404373748
akash_thakare93@outlook.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 |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
2 percentage of Chlorhexidine |
2% Chlorhexidine known for its broad-spectrum antimicrobial action and substantivity, meaning it adheres to dentin and mucosa for prolonged effectiveness. Used as an irrigant or intracanal medicament during root canal procedures. |
| Comparator Agent |
5.25 percentage Sodium Hypochlorite |
In the randomized controlled trial "Comparative Evaluation of Antimicrobial Efficacy of 5.25% Sodium Hypochlorite, 2% Chlorhexidine, Ozonated Olive Oil, and Diode Laser in Irreversible Pulpitis Cases," the comparators are the four different antimicrobial treatments will be evaluated. Here are the details of each comparator: 5.25% Sodium Hypochlorite is a commonly used irrigant in endodontics for its potent antimicrobial properties and ability to dissolve organic tissue. Applied as an irrigant during root canal therapy to disinfect the pulp chamber and root canals |
| Intervention |
5.25% Sodium hypochlorite, 2% Chlorhexidine, Ozonated Olive Oil and Diode laser |
Each intervention is carried out under standardized clinical conditions, with consistent protocols for the duration, activation techniques, and application methods. The primary outcome measure is the reduction in microbial load within the root canal system, assessed through microbiological sampling and analysis before and after the interventions. This allows for a comparative evaluation of the antimicrobial efficacy of each treatment modality in cases of irreversible pulpitis |
| Comparator Agent |
Diode Laser |
Diode Laser employs laser light to achieve antimicrobial effects through photothermal and photochemical actions, which can penetrate dentinal tubules more effectively. Used during root canal treatment to enhance disinfection by targeting and destroying bacteria within the pulp and dentin. |
| Comparator Agent |
Ozonated Olive Oil |
Ozonated Olive Oil utilized for its antimicrobial, anti-inflammatory, and healing properties. Ozone has been shown to have a strong oxidizing effect on microbes. Applied topically within the root canal system to achieve microbial reduction. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients requiring endodontic treatment with irreversible pulpitis and single rooted teeth will be included in the trial
|
|
| ExclusionCriteria |
| Details |
1. Medically / systemically compromised patients
2. Teeth where full working length cannot be reached
3. Teeth with periapical radiolucencies
4. Traumatic injuries
5. Teeth with developmental anomalies
6. Patients who do not give informed consent
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in microbial load by assessing the changes in bacterial colony forming units |
Baseline, post-operatively 12 hours, 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Antimicrobial efficacy achieved |
After 12 hours, 24 hours |
|
|
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
01/07/2025 |
| 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="2"
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
|
The primary purpose of the study "Comparative Evaluation of Antimicrobial Efficacy of 5.25% Sodium Hypochlorite, 2% Chlorhexidine, Ozonated Olive Oil, and Diode Laser in Irreversible Pulpitis Cases - A Randomized Controlled Trial" is to compare the antimicrobial efficacy of four different treatment modalities in patients with irreversible pulpitis. This involves assessing and determining which of the treatments—5.25% sodium hypochlorite, 2% chlorhexidine, ozonated olive oil, or diode laser—provides the most effective microbial reduction in the affected pulp tissue, thereby aiding in the management and treatment of this dental condition.
The study hypothesizes that there will be significant differences in the antimicrobial efficacy of 5.25% sodium hypochlorite, 2% chlorhexidine, ozonated olive oil, and diode laser when used in the treatment of patients with irreversible pulpitis. Specifically, it posits that one or more of these treatments will demonstrate superior microbial reduction compared to the others |