Comparison of Effectiveness of Disinfectants

Phase 1

Completed

• Conditions: Root Canal Infection
• Interventions: Drug: Sodium Hypochlorite; Drug: Chlorhexidine

• Registration Number: NCT06811779
• Lead Sponsor: Armed Forces Institute of Dentistry, Pakistan

Brief Summary

This is a comparative experimental study to compare the efficacy of chemical disinfection agents , sodium hypochlorite and chlorhexidine gluconate in decontaminating gutta percha cones

Detailed Description

The study design is a comparative study which was done to compare the efficacy of chemical disinfection agents on decontaminating the gutta percha cones .

In this study, 124 standardized size-80 gutta-percha (GP) cones (Dentsply, Germany) were used to assess the efficacy of chemical disinfectants.

The cones were first sterilized using ethylene oxide to ensure baseline sterility. Following sterilization, 124 cones were allocated into two experimental groups (n = 62 each) for contamination.

group A . gp were immersed in 20ml of Enterococcus faecalis solution group B . gp were immersed in 20 ml of human saliva in patients undergoing root canal therapy

samples were incubated at 37°C for 72 hours to ensure uniform and thorough contamination

after incubation period cones were dried and divide into subgroups based on disinfectant agent applied .

The cones were immersed in disinfectant agent for 1 min and 10 min . Cones were dried again and immersed in brain heard infusion broth samples were again incubated at 37°C for 72 hours The presence of bacterial growth was determined by assessing turbidity in the broth, indicating viable microorganisms.

Study Timeline

• Study Start: 2024-03-24
• Primary Completion: 2024-06-24
• Study Completion: 2024-06-25
• Status Verified: 2025-01
• Study First Submitted: 2025-01-19
• Study First Submitted QC: 2025-02-02
• Last Update Submitted: 2025-02-02
• Study First Posted: 2025-02-06
• Last Update Posted: 2025-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

• healthy individual age between 20-40 patient needed root canal therapy

Exclusion Criteria

• patient not willing to participate in study participants with systemic disease patients with neuromuscular disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Naocl group	Sodium Hypochlorite	In this group, the Gp cones would be submerged in 5% naocl solution for 5 minutes and then tested for biofilm removal and eradication of inoculated microorganisms.
chlorhexidine group	Chlorhexidine	In this group, the Gp cones would be submerged in 0.2% chlorhexidine solution for 5 minutes and then tested for biofilm removal and eradication of inoculated microorganisms.

Primary Outcome Measures

Name	Time	Method
effectiveness of disinfectants by assessing turbidity in broth using mann whitney test	24 weeks	Following disinfection, all gutta-percha (GP) cones were dried again with sterile gauze and placed individually into sterile test tubes containing 20 mL of fresh brain heart infusion (BHI) broth. The test tubes were incubated at 37°C for 72 hours. The presence of bacterial growth was determined by assessing turbidity in the broth, indicating viable microorganisms. Quantitative analysis of turbidity data was performed using the Mann-Whitney test and Kruskal-Wallis test to evaluate the effectiveness of the disinfectants across the groups.

Trial Locations

Locations (1)

Armed Forces Institute of Dentistry; 🇵🇰 Rawalpindi, Punjab, Pakistan