| CTRI Number |
CTRI/2023/08/057009 [Registered on: 28/08/2023] Trial Registered Prospectively |
| Last Modified On: |
14/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Use of various disinfectants in deep carious lesions |
|
Scientific Title of Study
|
Comparative evaluation of effectiveness of various disinfectants in deep carious lesion -an in vivo 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 Nitika Disodia |
| Designation |
Post Graduate student |
| Affiliation |
Government Dental College and Hospital |
| Address |
room no. 9, department of conservative dentistry and endodontics,
govt dental college and hospital, civil hospital campus,
asarwa,ahmedabad.380016
Ahmadabad
GUJARAT
380016
India
Room no. 512 c Block Dental girls hostel civil hospital campus,
asarwa,ahmedabad.380016
Ahmadabad
GUJARAT
380016
India
Ahmadabad
GUJARAT
380016
India |
| Phone |
7027949359 |
| Fax |
|
| Email |
disodianitika007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nupur Dhanak |
| Designation |
Assistant professor |
| Affiliation |
Government dental College and hospital |
| Address |
room no. 9, department of conservative dentistry and endodontics,
govt dental college and hospital, civil hospital campus,
asarwa,ahmedabad.380016
Ahmadabad
GUJARAT
380016
India
602, Sankalp Sapphire Opposite Ramada Hotel Phrahladnagar ahmedabad.380015
Ahmadabad
GUJARAT
380016
India
Ahmadabad
GUJARAT
380016
India |
| Phone |
9428198077 |
| Fax |
|
| Email |
bhavsarnupur@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nitika Disodia |
| Designation |
Post graduate student |
| Affiliation |
Government dental College and hospital |
| Address |
room no. 9, department of conservative dentistry and endodontics,
govt dental college and hospital, civil hospital campus,
asarwa,ahmedabad.380016
Ahmadabad
GUJARAT
380016
India
room no. 512 c block Dental girls hostel , civil hospital campus asarwa
GUJARAT
380016
India
Ahmadabad
GUJARAT
380016
India |
| Phone |
7027949359 |
| Fax |
|
| Email |
disodianitika007@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government dental college and hospital ,Ahmedabad |
|
|
Primary Sponsor
|
| Name |
Government Dental college and hospital |
| Address |
Government Dental college and hospital, civil hospital, asarwa , Ahmedabad |
| 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 Nitika Disodia |
government dental college and hospital, ahmedabad |
room no. 9, department
ofconservative dentistry
and endodontics,
government dental
college and hospital,
civil hospital
campus,asarwa.
ahmedabad.
Ahmadabad
GUJARAT
Ahmadabad
GUJARAT |
7027949359
disodianitika007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethical Committee Government Dental College and Hospital (IEC GDCH) |
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 |
| Intervention |
2 % chlorhexidine
|
2 % chlorhexidine for 60 sec,
|
| Comparator Agent |
Diode laser |
Diode laser 810 nm for 30 s in two cycles with 1.5 W power output that delivered a constant beam of light through a flexible optic fiber of 400 μm diameter with a straight handpiece in continuous wave mode |
| Comparator Agent |
diode laser with photosensitizer dye |
photoactivated disinfection wth diode laser |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Deep carious lesion
Normal response to EPT and thermal testing
No clinical and radiographic signs of pulp involvement
No history of spontaneous or night pain
No tender on percussion
|
|
| ExclusionCriteria |
| Details |
Any medical history if present
Previous dental treatment of involved tooth
Extensive tooth loss
Affected by periodontitis
Received any analgesic and antibiotic therapy since 4 weeks
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Photoactivated disinfection with diode laser should have better effect than chlorhexidine & diode laser as cavity disinfectant |
the outcome will be assessed after 1 month & 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Use of disinfectant should increase success of the treatment preventing need for root canal treatment. |
the outcome will be assessed after 1 month & 6 months |
|
|
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)
|
01/09/2023 |
| 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="6"
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
|
Comparative evaluation of effectiveness of various disinfectants in deep carious
lesion -an in vivo studyAIM
The aim of this study is to access and compare the cavity disinfection efficacy of chlorhexidine, diode laser and
photo-activated disinfection with Diode laser in deep carious lesion. OBJECTIVE • To evaluate decrease in bacterial count in deep carious lesion, after treating cavity with
2% chlorhexidine, 810nm diode laser at 1.5 W and using Photoactivated disinfection
with Diode laser. • To evaluate the clinical and radiographic success of cases treated with all the three
cavity disinfectant technique at 24 hours ,1 month and 6 months follow up
Criteria for evaluation
Microbiological Evaluation will be done by inoculation of dentinal sample before and after
cavity disinfection on culture media.
Clinical Evaluation
â–ª pain assessment with VAS scale
â–ª vitality using thermal and electric pulp testing
â–ª tenderness on percussion
Radiographic evaluation at 24 hours, 1 month and 6 months |