COMPARISON OF ANTIBACTERIAL EFFICACY OF DIFFERENT ROOT CANAL DISINFECTING AGENTS IN PRIMARY TEETH

Phase 2/3

Not yet recruiting

• Conditions: Necrosis of pulp,

• Registration Number: CTRI/2022/12/048411
• Lead Sponsor: Dr Shilpa S

Brief Summary

Endodontic therapy is a debridement procedure thatrequires complete removal of microorganisms and dead tissue from the root canaland periapical tissue. Irrigation has been used along with mechanicalinstrumentation to achieve better debridement. Over the decade, the use ofherbal drugs as intracanal medicament has increased. One such immenselyvaluable plant regarding its constituent and pharmacology is *Tinospora cordifolia*of the **Menispermaceae** family, commonly called **Guduchi** in Sanskrit. To overcomethe adverse effects of present chemical root canal irrigant, a shift to herbalagents is being studied. *Tinospora cordifolia* is one among the herbalagents that can be used as an intracanal irrigant because of its antimicrobialproperties.

The extract will be prepared in twoconcentrations 2 percent and 3 percent, other comparative agents SodiumHypochlorite 3 percent, Chlorhexidine Gluconate 2 percent and Normal Saline willbe commercially procured. Patients will be selected depending on the inclusionand exclusion criteria. After sample selection, the tooth under the study willbe anesthetise using 2 percent lignocaine and a straight-line access to the canalswill be prepared. A first set of root canal samples will be collected using asterile paper point. For standardization, the samples will be collected fromthe palatal root in the maxillary arch and distal root in the mandibular arch. Aftercollection of first set of samples, the canals will be irrigated with therespective irrigants along with the cleaning and shaping of the canals andsecond set of samples will be collected after using the irrigants. The patientis recalled after 3 days and a third set of samples are collected and the rootcanals are obturated. The collected samples will be stored in a vial containingnormal saline and is sent for microbial assessment of gram positive and gramnegative, aerobic and anaerobic microorganisms.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-12-21
• Study Start: 2022-12-29

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Antimicrobial efficacy of Tinospora cordifolia in root canal disinfection.	Baseline: Before the intervention | First time point: Immediately after the intervention | Second time point: 3 days post intervention
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 Measures

Name	Time	Method
Clinically there is no pain, pus discharge from the root canals post intervention	Microbiologically there is decrease in the microbial count post intervention

Trial Locations

Locations (1)

M R Ambedkar Dental College and Hospital; 🇮🇳 Bangalore, KARNATAKA, India

M R Ambedkar Dental College and Hospital

🇮🇳Bangalore, KARNATAKA, India

Dr Shilpa S

Principal investigator

08971091990

rangneela@gmail.com