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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  
Status 
Not Applicable 
 
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.

 
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