Comparison of Effectiveness of Disinfectants

NCT06811779 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: Disinfection
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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

Conditions

Root Canal Infection

Keywords

chemical disinfection; chlorhexidine gluconate; gutta percha; sodium hypochlorite

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Naocl group

ACTIVE COMPARATOR

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

chlorhexidine group

ACTIVE COMPARATOR

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

Interventions

Sodium Hypochlorite DRUG

Sodium hypochlorite used in 5% concentration for disinfection

Naocl group

Chlorhexidine DRUG

Chlorhexidine 0.2% concentration for disinfection

chlorhexidine group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Armed Forces Institute of Dentistry, Pakistan: lead

Study Sites (1)

Armed Forces Institute of Dentistry

Rawalpindi, Punjab Province, 46000, Pakistan

Location

MeSH Terms

Interventions

Sodium Hypochlorite; Chlorhexidine

Intervention Hierarchy (Ancestors)

Hypochlorous Acid; Chlorine Compounds; Inorganic Chemicals; Oxides; Oxygen Compounds; Sodium Compounds; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Hafiza Hira Amjad, BDS

  Armed Forces Institute of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Hafiza Hira Amjad

Study Record Dates

• First Submitted: January 19, 2025
• First Posted: February 6, 2025
• Study Start: March 24, 2024
• Primary Completion: June 24, 2024
• Study Completion: June 25, 2024
• Last Updated: February 6, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)