| CTRI Number |
CTRI/2024/10/075796 [Registered on: 24/10/2024] Trial Registered Prospectively |
| Last Modified On: |
23/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
A clinical study to check different disinfection techniques on the reduction of bacteria and its byproducts in the infected teeth. |
|
Scientific Title of Study
|
Efficacy of ultrasonic activation and adjunctive laser irradiation on the bacterial load and endotoxin level of infected root canals : An ex-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 Adarsha MS |
| Designation |
Professor |
| Affiliation |
Vokkaligara sangha dental college and hospital |
| Address |
Room no 6 Department of conservative dentistry and endodontics VS dental college and hospital KR Road VV puram Bengaluru
Bangalore
KARNATAKA
560004
India |
| Phone |
9844474688 |
| Fax |
|
| Email |
adarshgowda11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanika K |
| Designation |
Post graduate student |
| Affiliation |
Vokkaligara sangha dental college and hospital |
| Address |
Room no 6 Department of conservative dentistry and endodontics VS dental college and hospital KR Road VV puram Bengaluru
Bangalore
KARNATAKA
560004
India |
| Phone |
9483877818 |
| Fax |
|
| Email |
sanikakanayya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Adarsha MS |
| Designation |
Professor |
| Affiliation |
Vokkaligara sangha dental college and hospital |
| Address |
Room no 6 Department of conservative dentistry and endodontics VS dental college and hospital KR Road VV puram Bengaluru
Bangalore
KARNATAKA
560004
India |
| Phone |
9844474688 |
| Fax |
|
| Email |
adarshgowda11@gmail.com |
|
|
Source of Monetary or Material Support
|
| VS dental college and hospital Bengaluru 560004 India |
|
|
Primary Sponsor
|
| Name |
Dr Adarsha MS |
| Address |
VS dental college and hospital KR Road VV puram Bengaluru 560004 India |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Sanika K |
V.S.dental college and hospital, K.R. Road,VV puram, Bengaluru 560004 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Adarsha MS |
VS dental college and hospital |
Room no 6 Department of conservative dentitstry and endodontics KR Road VV puram Bengaluru 560004
Bangalore
KARNATAKA |
9844474688
adarshgowda11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Kempegowda institute of medical sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K045||Chronic apical periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Irrigant activation |
Irrigant activation in the root canal using ultrasonics once for 60 seconds and adjunctive diode laser irradiation once for 60 seconds in one group |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1)Single rooted teeth with single canal and pulp necrosis 2)Patients with primary endodontic infection 3)Radiographic evidence of apical periodontitis verified with CBCT |
|
| ExclusionCriteria |
| Details |
1)Teeth diagnosed with periodontal problems and pocket depth more than 4mm 2)Teeth previously treated with root canal procedure 3)Patients who received antibiotics in past 3 months 4)Teeth which cannot be isolated with rubber dam |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluating bacterial reduction and its byproducts in infected teeth using different disinfection techniques |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assesment of reduction in bacterial load & endotoxin |
one month |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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
|
N/A |
|
Date of First Enrollment (India)
|
04/11/2024 |
| 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="0"
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
|
This is an ex-vivo study comparing and assessing ultrasonic activation method and adjunctive laser irraditaion method on bacterial load and endotoxin level in single rooted teeth with apical periodontitis using rapid adenosine triphosphate detection method and limulus amebocyte lysate assay |