Comparison of Effectiveness of Disinfectants

Comparison of Effectiveness of Sodium Hypochlorite and Chlorhexidine Gluconate for Disinfection of Gutta Percha Cones

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

Study Overview

• Status: Completed
• Conditions: Root Canal Infection
• Intervention / Treatment: Drug: Sodium Hypochlorite; Drug: Chlorhexidine

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 Type: Interventional
• Enrollment (Actual): 124
• Phase: Phase 1

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Rawalpindi, Punjab, Pakistan, 46000
      • Armed Forces Institute of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Naocl group; 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.	Drug: Sodium Hypochlorite; Sodium hypochlorite used in 5% concentration for disinfection
Active Comparator: chlorhexidine group; 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.	Drug: Chlorhexidine; Chlorhexidine 0.2% concentration for disinfection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
effectiveness of disinfectants by assessing turbidity in broth using mann whitney test	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.	24 weeks

Collaborators and Investigators

• Sponsor: Armed Forces Institute of Dentistry, Pakistan
• Investigators: Principal Investigator: Hafiza Hira Amjad, BDS, Armed Forces Institute of Dentistry

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2024
• Primary Completion (Actual): June 24, 2024
• Study Completion (Actual): June 25, 2024

Study Registration Dates

• First Submitted: January 19, 2025
• First Submitted That Met QC Criteria: February 2, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 2, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: chlorhexidine gluconate; sodium hypochlorite; chemical disinfection; gutta percha
• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Infective Agents, Local; Disinfectants; Chlorhexidine; Sodium Hypochlorite; Eusol
• Other Study ID Numbers: Disinfection

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes