CTRI Number |
CTRI/2022/12/048411 [Registered on: 22/12/2022] Trial Registered Prospectively |
Last Modified On: |
21/12/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Dentistry |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
COMPARISON OF ANTIBACTERIAL EFFICACY OF DIFFERENT ROOT CANAL DISINFECTING AGENTS IN PRIMARY TEETH |
Scientific Title of Study
|
COMPARATIVE EVALUATION OF ANTIMICROBIAL EFFICACY OF TINOSPORA CORDIFOLIA, SODIUM HYPOCHLORITE AND CHLORHEXIDINE GLUCONATE IN ROOT CANAL DISINFECTION OF PRIMARY TEETH: A CLINICAL 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 Shilpa S |
Designation |
Postgraduate Student |
Affiliation |
M R Ambedkar Dental College and Hospital |
Address |
Department of Pediatric and Preventive Dentistry
Room no 2nd floor
M R Ambedkar Dental College and Hospital
1/36 CLINE ROAD COOKE TOWN
BENGALURU 560005
Department of Pediatric and Preventive Dentistry
Room no 2nd floor
M R Ambedkar Dental College and Hospital
1/36 CLINE ROAD COOKE TOWN
BENGALURU 560005
Bangalore KARNATAKA 560005 India |
Phone |
08971091990 |
Fax |
|
Email |
rangneela@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Jyothsna V Setty |
Designation |
Professor |
Affiliation |
M R Ambedkar Dental College and Hospital |
Address |
Department of Pediatric and Preventive Dentistry
M R Ambedkar Dental College and Hospital
1/36 Cline road Cooke town
Bangalore 560005
Bangalore KARNATAKA 560005 India |
Phone |
9449819468 |
Fax |
|
Email |
jyothsnasrikanth@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Shilpa S |
Designation |
Postgraduate Student |
Affiliation |
M R Ambedkar Dental College and Hospital |
Address |
epartment of Pediatric and Preventive Dentistry
Room no 2nd floor
M R Ambedkar Dental College and Hospital
1/36 CLINE ROAD COOKE TOWN
BENGALURU 560005
Department of Pediatric and Preventive Dentistry
Room no 2nd floor
M R Ambedkar Dental College and Hospital
1/36 CLINE ROAD COOKE TOWN
BENGALURU 560005
Bangalore KARNATAKA 560005 India |
Phone |
08971091990 |
Fax |
|
Email |
rangneela@gmail.com |
|
Source of Monetary or Material Support
|
M R Ambedkar Dental College and Hospital
1/36 Cline road Cooke town
Bangalore- 560005 |
|
Primary Sponsor
|
Name |
Dr Shilpa S |
Address |
17 14th Cross Cubbonpet Bangalore 560002 |
Type of Sponsor |
Other [Self] |
|
Details of Secondary Sponsor
|
Name |
Address |
M R Ambedkar Dental College and Hospital |
1/36 CLINE ROAD COOKE TOWN
BENGALURU- 560005
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Shilpa S |
M R Ambedkar Dental College and Hospital |
Department of Pediatric and Preventive Dentistry
Room No 7
2nd Floor
1/36 Cline road Cooke Town
Bangalore 560005 Bangalore KARNATAKA |
08971091990
rangneela@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committe M R Ambedkar Dental College and Hospital |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: K041||Necrosis of pulp, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Chlorhexidine Gluconate |
Chlorhexidine Gluconate 2%- Group 5 will be used as the third comparative agent.
This irrigant will be used for 15 seconds in each root canal |
Comparator Agent |
Normal Saline
|
Group 1- Normal Saline (Control group) will be used as the first group of comparative agent.
This irrigant will be used for 15 seconds in each root canal |
Comparator Agent |
Sodium Hypochlorite |
Sodium Hypochlorite 3%- Group 4 will be used as second comparative aagent.
This irrigant will be used for 15 seconds in each root canal |
Intervention |
Tinospora Cordifolia ethanolic extract (2% and 3%) |
Group 2- Ethanolic extract of Tinospora Cordifolia of concentration 2%
Group 3- Ethanolic extract of Tinospora Cordifolia of concnetration 3%
will be used as intervention agents.
These irrigants will be used for 15 seconds in each root canal |
|
Inclusion Criteria
|
Age From |
4.00 Year(s) |
Age To |
9.00 Year(s) |
Gender |
Both |
Details |
1.Patients who belonged to Frankel’s 3 and Frankel’s 4 behavioural rating scale.
2.Patients between the age of 4-9 years of both sexes with no history of systemic illness.
3.Teeth with carious pulpal involvement which are indicated for pulpectomy.
4.Teeth with at least 2/3rd of root length intact.
5.Teeth which are restorable.
6.Patients who wilfully give assent and for whom the parents or guardian will give the written informed consent to be a part of this study.
|
|
ExclusionCriteria |
Details |
1.Teeth with pre-shedding mobility or abnormal pathologic mobility.
2.Teeth with root resorption which is more than 1/3rd of the root length.
3.Teeth which are not resorbable.
4.Teeth which show perforation of the pulpal floor.
5.Teeth with interdental bone loss.
6.Teeth with pathologic lesions like radicular granuloma or cyst.12
7.Patient with special health care needs.
8.Patients who are not willing or for whom the parent or the guardian did not give the written informed consent for the treatment.
9.Patients who are suffering from any other debilitating systemic illness.
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
On-site computer system |
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Antimicrobial efficacy of Tinospora cordifolia in root canal disinfection.
The efficacy of the extract will be assessed by the antimicrobial evaluation of gram positive and gram negative ,aerobic and anaerobic microorganisms through suitable culture methods |
Baseline: Before the intervention
First time point: Immediately after the intervention
Second time point: 3 days post intervention |
|
Secondary Outcome
|
Outcome |
TimePoints |
Clinically there is no pain, pus discharge from the root canals post intervention
Microbiologically there is decrease in the microbial count post intervention
|
Baseline before the intervention
First time line Immediately after the intervention
Second timeline 3days post intervention |
|
Target Sample Size
|
Total Sample Size="75" Sample Size from India="75"
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)
|
29/12/2022 |
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="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
Not yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Endodontic therapy is a debridement procedure that
requires complete removal of microorganisms and dead tissue from the root canal
and periapical tissue. Irrigation has been used along with mechanical
instrumentation to achieve better debridement. Over the decade, the use of
herbal drugs as intracanal medicament has increased. One such immensely
valuable plant regarding its constituent and pharmacology is Tinospora cordifolia
of the Menispermaceae family, commonly called Guduchi in Sanskrit. To overcome
the adverse effects of present chemical root canal irrigant, a shift to herbal
agents is being studied. Tinospora cordifolia is one among the herbal
agents that can be used as an intracanal irrigant because of its antimicrobial
properties.
The extract will be prepared in two
concentrations 2 percent and 3 percent, other comparative agents Sodium
Hypochlorite 3 percent, Chlorhexidine Gluconate 2 percent and Normal Saline will
be commercially procured. Patients will be selected depending on the inclusion
and exclusion criteria. After sample selection, the tooth under the study will
be anesthetise using 2 percent lignocaine and a straight-line access to the canals
will be prepared. A first set of root canal samples will be collected using a
sterile paper point. For standardization, the samples will be collected from
the palatal root in the maxillary arch and distal root in the mandibular arch. After
collection of first set of samples, the canals will be irrigated with the
respective irrigants along with the cleaning and shaping of the canals and
second set of samples will be collected after using the irrigants. The patient
is recalled after 3 days and a third set of samples are collected and the root
canals are obturated. The collected samples will be stored in a vial containing
normal saline and is sent for microbial assessment of gram positive and gram
negative, aerobic and anaerobic microorganisms. |