| CTRI Number |
CTRI/2022/05/042674 [Registered on: 19/05/2022] Trial Registered Prospectively |
| Last Modified On: |
25/11/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the ability of 2 treatment modalities on reducing infection of patients requiring root canal treatment on infected teeth |
|
Scientific Title of Study
|
Comparative evaluation of the effect of calcium hydroxide medicament and low level laser therapy on endotoxin level in Apical periodontitis – An in-vivo study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr AdarshaMS |
| Designation |
Professor |
| Affiliation |
Vokkaligara sangha Dental College and Hospital |
| Address |
Department Of Conservative Dentistry And Endodontics,
Vokkaligara sangha Dental College and Hospital,
K R Road, Visvesvarapuram, Bengaluru,
Karnataka 560004
Bangalore
KARNATAKA
560004
India |
| Phone |
9844474688 |
| Fax |
|
| Email |
adarshsgowda@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr AdarshaMS |
| Designation |
Professor |
| Affiliation |
Vokkaligara sangha Dental College and Hospital |
| Address |
Department Of Conservative Dentistry And Endodontics,
Vokkaligara sangha Dental College and Hospital,
K R Road, Visvesvarapuram, Bengaluru,
Karnataka 560004
Bangalore
KARNATAKA
560004
India |
| Phone |
9844474688 |
| Fax |
|
| Email |
adarshsgowda@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr AdarshaMS |
| Designation |
Professor |
| Affiliation |
Vokkaligara sangha Dental College and Hospital |
| Address |
Department Of Conservative Dentistry And Endodontics,
Vokkaligara sangha Dental College and Hospital,
K R Road, Visvesvarapuram, Bengaluru,
Karnataka 560004
Bangalore
KARNATAKA
560004
India |
| Phone |
9844474688 |
| Fax |
|
| Email |
adarshsgowda@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Advanced research grant by:
Rajiv Gandhi University of Health Sciences,
4th T Block, Jayanagar,
Bengaluru-560041,
Karnataka
India.
Ph No:080-26961933 |
|
|
Primary Sponsor
|
| Name |
Rajiv Gandhi University of Health Sciences |
| Address |
Rajiv Gandhi University of Health Sciences,Bangalore, Karnataka
|
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Vokkaligara Sangha Dental College and Hospital |
Vokkaligara Sangha Dental College and Hospital, K R Road, Visvesvarapuram, Bengaluru, Karnataka -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 AdarshaMS |
Vokkaligara Sangha Dental College and Hospital |
Department Of Conservative Dentistry And Endodontics, Vokkaligara Sangha Dental College and Hospital, K R Road, Visvesvarapuram, Bengaluru, Karnataka -560004
Bangalore
KARNATAKA |
9844474688
adarshsgowda@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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, (2) ICD-10 Condition: A488||Other specified bacterial diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
calcium hydroxide intracanal medicament and low level laser therapy for 14 days and 30 days |
To assess the effect of combination of calcium hydroxide intracanal medicament and low level laser therapy and its combination as final disinfectant on bacterial endotoxin level in apical periodontitis |
| Comparator Agent |
calcium hydroxide intracanal medicament for 14 days and 30 days |
To assess the effect of combination of calcium hydroxide intracanal medicament as final disinfectant on bacterial endotoxin level in apical periodontitis |
|
|
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.Primary endodontic infection
3.Radiographic evidence of apical periodontitis verified with CBCT |
|
| ExclusionCriteria |
| Details |
1.Teeth which are diagnosed with periodontal problems and with periodontal pocket of more than 4mm
2.Teeth which were previously treated with root canal procedure
3.Patient who received antibiotic in past 3 months and
4.Teeth which cannot be isolated by rubber dam |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess and compare the effect of calcium hydroxide intra-canal medicament and low level laser therapy and its combinations as final disinfectant on bacterial endotoxin level in apical periodontitis |
2 time intervals - 14 days and 30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The effect of low level laser therapy as final disinfectant on bacterial endotoxin level immediately after laser disinfection will be measured |
one time interval |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/06/2022 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response (Others) -
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [adarshsgowda@yahoo.com].
- For how long will this data be available start date provided 02-01-2021 and end date provided 02-12-2023?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study is a interventional, randomized, parallel group, active controlled trial to assess and compare the effect of calcium hydroxide intra-canal medicament and low level laser therapy and its combination as final disinfectant on bacterial endotoxin level in apical periodontitis that will be conducted in Vokkaligara sangha dental college and hospital, Bangalore, India. The primary outcome measures will be the effect of calcium hydroxide intra-canal medicament and combination of low level laser therapy and calcium hydroxide as final disinfection on bacterial endotoxin level at 14 days and 30 days interval. Also, the effect of low level laser therapy as final disinfectant on bacterial endotoxin level immediately after laser disinfection will be measured. |