Antibacterial Effectiveness of Two Root Canal Irrigants

April 18, 2016 updated by: Homan Zandi, University of Oslo

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

49

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0317
        • University of Oslo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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).
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.
Active Comparator: 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).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Periapical radiolucency (PAI- and Friedman-scores)
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Bacterial load assessed by qPCR
Time Frame: 21 days
21 days
Pyrosequencing of species found before and after the intervention
Time Frame: 21 days
21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oslo

Collaborators

Universidade Estácio de Sá

Investigators

  • Study Chair: Dag MR Ørstavik, DDS, PhD, Chair of the endodontic department, University of Oslo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

March 21, 2016

First Submitted That Met QC Criteria

April 18, 2016

First Posted (Estimate)

April 21, 2016

Study Record Updates

Last Update Posted (Estimate)

April 21, 2016

Last Update Submitted That Met QC Criteria

April 18, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012/364/REK

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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