Antibacterial Effectiveness of Two Root Canal Irrigants

NCT ID: NCT02747082

Last Updated: 2016-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-01-31

Brief Summary

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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

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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.

Conditions

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Periapical Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1% sodium hypochlorite (NaOCl)

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).

Group Type ACTIVE_COMPARATOR

Retreatment of root-filled teeth with infection

Intervention Type PROCEDURE

Root-filled teeth with infection are being treated with either 1% NaOCl or 2% CHX as disinfection irrigation solution.

2% chlorhexidine gluconate (CHX)

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).

Group Type ACTIVE_COMPARATOR

Retreatment of root-filled teeth with infection

Intervention Type PROCEDURE

Root-filled teeth with infection are being treated with either 1% NaOCl or 2% CHX as disinfection irrigation solution.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidade Estácio de Sá

UNKNOWN

Sponsor Role collaborator

University of Oslo

OTHER

Sponsor Role lead

Responsible Party

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Homan Zandi

DDS

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dag MR Ørstavik, DDS, PhD

Role: STUDY_CHAIR

Chair of the endodontic department, University of Oslo

Locations

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University of Oslo

Oslo, Oslo County, Norway

Site Status

Countries

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Norway

References

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Rocas 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.

Reference Type RESULT
PMID: 21238793 (View on PubMed)

Other Identifiers

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2012/364/REK

Identifier Type: -

Identifier Source: org_study_id

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