Antibacterial Effectiveness of Two Root Canal Irrigants

Phase 2

Completed

• Conditions: Periapical Periodontitis
• Interventions: Procedure: Retreatment of root-filled teeth with infection

• Registration Number: NCT02747082
• Lead Sponsor: University of Oslo

Brief Summary

The aim of this randomized clinical trial is to compare the antibacterial effects of 1% sodium hypochlorite (NaOCl) and 2% chlorhexidine gluconate (CHX) during retreatment of teeth with apical periodontitis (AP).

Detailed Description

Root canal-treated teeth with AP were randomly distributed in two groups according to the irrigant used. After removal of the previous filling material, bacteriological samples were taken from the canals before (S1) and after chemomechanical preparation using either NaOCl or CHX (S2), and after calcium hydroxide medication for 2-3 weeks (S3). 16S rRNA gene-based real-time qPCR was performed to detect and quantify total bacteria, Streptococcus species and Enterococcus faecalis.

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Study First Submitted: 2016-03-21
• Status Verified: 2016-04
• Study First Submitted QC: 2016-04-18
• Last Update Submitted: 2016-04-18
• Study First Posted: 2016-04-21
• Last Update Posted: 2016-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

• Clinical diagnosis of apical periodontitis in a root-filled tooth assessed by radiography.

Exclusion Criteria

• Presence of gross carious lesions in the diagnosed tooth,
• Presence of fractures involving the periodontium of the diagnosed tooth,
• Presence of periodontal pockets more than 4 mm deep in the diagnosed tooth,
• Diagnosis of diabetes,
• Diagnosis of HIV infection,
• Other immunocompromising disease,
• Antibiotic therapy within the previous 3 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1% sodium hypochlorite (NaOCl)	Retreatment of root-filled teeth with infection	Retreatment of root-filled teeth with infection with 1% NaOCl as irrigation solution. Total bacterial counts, Streptococcal species and Enterococcus faecalis species were quantified using qPCR against 16SrRNA before irrigation (S1), after irrigation (S2), and after intracanal medication (S3).
2% chlorhexidine gluconate (CHX)	Retreatment of root-filled teeth with infection	Retreatment of root-filled teeth with infection with 2% CHX as irrigation solution. Total bacterial counts, Streptococcal species and Enterococcus faecalis species were quantified using qPCR against 16SrRNA before irrigation (S1), after irrigation (S2), and after intracanal medication (S3).

Primary Outcome Measures

Name	Time	Method
Periapical radiolucency (PAI- and Friedman-scores)	12 months

Secondary Outcome Measures

Name	Time	Method
Pyrosequencing of species found before and after the intervention	21 days
Bacterial load assessed by qPCR	21 days

Trial Locations

Locations (1)

University of Oslo; 🇳🇴 Oslo, Norway