Antibacterial Effectiveness of Two Root Canal Irrigants

Periapical Periodontitis Clinical Trial

Official title:

Antibacterial Effectiveness of Two Root Canal Irrigants in Root-filled Teeth With Infection: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02747082
• Other study ID #: 2012/364/REK
• Status: Completed
• Phase: Phase 2
• First received: March 21, 2016
• Last updated: April 18, 2016
• Start date: January 2012
• Est. completion date: January 2013

Study information

• Verified date: April 2016
• Source: University of Oslo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Regional Ethics Commitee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 95 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Periapical Periodontitis
• Periodontitis

Intervention

Procedure:
• Retreatment of root-filled teeth with infection
Root-filled teeth with infection are being treated with either 1% NaOCl or 2% CHX as disinfection irrigation solution.

Locations

Country	Name	City	State
Norway	University of Oslo	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
University of Oslo	Universidade Estácio de Sá

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Rôças IN, Siqueira JF Jr. Comparison of the in vivo antimicrobial effectiveness of sodium hypochlorite and chlorhexidine used as root canal irrigants: a molecular microbiology study. J Endod. 2011 Feb;37(2):143-50. doi: 10.1016/j.joen.2010.11.006. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Periapical radiolucency (PAI- and Friedman-scores)		12 months	No
Secondary	Bacterial load assessed by qPCR		21 days	No
Secondary	Pyrosequencing of species found before and after the intervention		21 days	No