| CTRI Number |
CTRI/2025/02/080343 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
11/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study on Irrigation |
|
Scientific Title of Study
|
Evaluation of Effectiveness of different photosensitizers used in laser activated disinfection in endodontic infection - An invivo study |
| 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 Nandina Navya Haritha |
| Designation |
MDS Student |
| Affiliation |
|
| Address |
Room-9, Department of Conservative Dentistry and Endodontics, Government Dental College and Hospital, Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
09491256593 |
| Fax |
|
| Email |
nandinanavyaharitha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shikha Kanodia |
| Designation |
Professor |
| Affiliation |
|
| Address |
Room-9, Department of Conservative Dentistry and Endodontics,Government Dental College and Hospital, Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
9825465861 |
| Fax |
|
| Email |
shikhakk@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Shikha Kanodia |
| Designation |
Professor |
| Affiliation |
Government Dental College and Hospital, Ahmedabad |
| Address |
Room-9, Department of Conservative Dentistry and Endodontics,Government Dental College and Hospital, Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
9825465861 |
| Fax |
|
| Email |
shikhakk@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Room No.9, Department of Conservative Dentistry and Endodontics, Government dental college and hospital, Ahmedabad-380016, Gujarat, India. |
|
|
Primary Sponsor
|
| Name |
Biocare Research Pvt Ltd |
| Address |
Biocare Research(India) Pvt Ltd,
1st Floor, Kanth Complex, Hotel NilKanth, AMTS Bus Stop, Parimal Cross Rd, opp. Paldi, near Mahavir Jain Vidyalalya, Paldi, Ahmedabad, Gujarat 380006, INDIA. |
| Type of Sponsor |
Other [Biocare Research Pvt Ltd] |
|
|
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 Navya Haritha |
Government dental college and Hospital, ahmedabad |
Room No.9, Department of Conservative Dentistry and Endodontics, Government dental college and hospital, Ahmedabad-380016, Gujarat, India
Ahmadabad
GUJARAT |
09491256593
nandinanavyaharitha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Govt Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K047||Periapical abscess without sinus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Photoactivated disinfection |
Total viable count is compared before and after intervention and also periapical healing is also compared
Groups of the study as follows
Group-1: Control(Naocl)
Group-2: PAD using toulidene blue
Group-3: PAD using rosebengal dye
|
| Intervention |
Photoactivated disinfection using rosebengal dye |
Group-3:Photoactivated disinfection performed using rosebengal dye
|
| Intervention |
Photoactivated disinfection using toulidene blue |
Group-2: Photoactivated disinfection performed using toulidene blue |
| Intervention |
Root canal treatment using Sodium hypochlorite(Naocl) |
Group-1: Control(Naocl)
Root canal treatment is performed using only Naocl as irrigant |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Irreversible pulpitis with apical periodontitis
Pulpal necrosis
Failed root canal therapy
|
|
| ExclusionCriteria |
| Details |
Patients with any systemic diseases.
Pregnant patients.
Previously initiated therapy
Calcified canals.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Postoperative bacterial TVC will be less in photoactivated disinfection group |
Pre & Post operative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| periapical healing will be faster in photoactivated disinfection group |
3months, 6months |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
23/02/2025 |
| 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="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
|
Aim: The aim of this study is to access and compare the disinfection efficacy of different photosensitizers in laser activated disinfection in endodontic infection.
The objective of this study is : • To evaluate the decrease in bacterial count after disinfection with Naocl, Photoactivated disinfection with toluidine blue & rose bengal dye • To evaluate the clinical outcome & radiographic outcome of cases treated with Naocl, Photoactivated disinfection with toluidine blue & rose bengal dye at 1, 3 and 6 months follow up. |