Disinfection achieved during root canal treatment by 2 disinfecting agents -bromelain (pineapple stem extract), and sodium hypochlorite (the current treatment standard).

Phase 2

Not yet recruiting

• Conditions: Infected root canals (irreversible pulpitis or necrotic pulp with apical periodontitis)

• Registration Number: CTRI/2017/07/009015
• Lead Sponsor: Rajiv Gandhi University of Health Sciences

Brief Summary

This is a clinical study proposed to be conducted during routine root canal treatment. Disinfection is conventionally achieved by an irrigant called sodium hypochlorite. This agent has antimicrobial and pulp dissolving action, but suffers from inferior biocompatibility to soft tissues. The proposed irrigant is Bromelain, a non-toxic pineapple-derived proteolytic enzyme. Its antimicrobial effects have been established in-vitro, and it has been used in patients with burn injury to remove necrotic tissue, while not harming the vital soft tissues. It has also been used as an anti-inflammatory agent after tooth extraction. It is also economical, being comparable to sodium hypochlorite.

In this study, the antimicrobial efficacy will be assessed clinically, comparing the disinfection efficacy of sodium hypochlorite and bromelain.

The clinical study will be presented to the Institutional Review Board of the college. Awaiting this approval, an application will be sent for a research grant to the university. Once grants are obtained, the recruitment of patients (out-patients) will begin.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-12
• Last Update Posted: 2017-07-07

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Maxillary or mandibular, incisors or canines; Endodontic diagnosis of irreversible pulpitis/ necrotic pulp, with apical periodontitis.

Exclusion Criteria

Previous endodontic treatment; Post-endodontic restoration not feasible; Intentional RCT; Vital pulp requiring RCT due to contraindication of vital pulp therapy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Microbial analysis (change in Colony forming units).	1. Pre-operative microbial sampling; | 2. Post-disinfection microbial sampling. | There is no follow-up.

Trial Locations

Locations (1)

Bapuji Dental College and Hospital; 🇮🇳 Davanagere, KARNATAKA, India

Bapuji Dental College and Hospital

🇮🇳Davanagere, KARNATAKA, India

Sherin Jose Chockattu

Principal investigator

9535542942

sherinjose.com@gmail.com