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NCT Number: NCT02747082

Antibacterial Effectiveness of Two Root Canal Irrigants

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).

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Key information

Conditions

Periapical Periodontitis Jaw Diseases Mouth Diseases Periapical Diseases Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

20 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Oslo

Oslo, 0317, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Retreatment of root-filled teeth with infection

Procedure

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

Primary outcomes

  1. Periapical radiolucency (PAI- and Friedman-scores)

    Time frame: 12 months

Secondary outcomes

  1. Bacterial load assessed by qPCR

    Time frame: 21 days

  2. Pyrosequencing of species found before and after the intervention

    Time frame: 21 days

Sponsors and collaborators

Lead sponsor

University of Oslo

Other

Collaborators

  • Universidade Estácio de Sá

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 21, 2016
Registry last updated
Apr 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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