Back to resultsAntibacterial Effectiveness of Two Root Canal Irrigants
Primary Purpose
Periapical Periodontitis
Status
Completed
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
Retreatment of root-filled teeth with infection
Sponsored by
About this trial
This is an interventional treatment trial for Periapical Periodontitis focused on measuring endodontic retreatment, sodium hypochlorite, chlorhexidine, calcium hydroxide, Retreatment
Eligibility Criteria
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.
Sites / Locations
- University of Oslo
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1% sodium hypochlorite (NaOCl)
2% chlorhexidine gluconate (CHX)
Arm Description
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).
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).
Outcomes
Primary Outcome Measures
Periapical radiolucency (PAI- and Friedman-scores)
Secondary Outcome Measures
Bacterial load assessed by qPCR
Pyrosequencing of species found before and after the intervention
Full Information
NCT ID
NCT02747082
First Posted
March 21, 2016
Last Updated
April 18, 2016
Sponsor
University of Oslo
Collaborators
Universidade Estácio de Sá
1. Study Identification
Unique Protocol Identification Number
NCT02747082
Brief Title
Antibacterial Effectiveness of Two Root Canal Irrigants
Official Title
Antibacterial Effectiveness of Two Root Canal Irrigants in Root-filled Teeth With Infection: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oslo
Collaborators
Universidade Estácio de Sá
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periapical Periodontitis
Keywords
endodontic retreatment, sodium hypochlorite, chlorhexidine, calcium hydroxide, Retreatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1% sodium hypochlorite (NaOCl)
Arm Type
Active Comparator
Arm Description
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).
Arm Title
2% chlorhexidine gluconate (CHX)
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Procedure
Intervention Name(s)
Retreatment of root-filled teeth with infection
Intervention Description
Root-filled teeth with infection are being treated with either 1% NaOCl or 2% CHX as disinfection irrigation solution.
Primary Outcome Measure Information:
Title
Periapical radiolucency (PAI- and Friedman-scores)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Bacterial load assessed by qPCR
Time Frame
21 days
Title
Pyrosequencing of species found before and after the intervention
Time Frame
21 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dag MR Ørstavik, DDS, PhD
Organizational Affiliation
Chair of the endodontic department, University of Oslo
Official's Role
Study Chair
Facility Information:
Facility Name
University of Oslo
City
Oslo
ZIP/Postal Code
0317
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
21238793
Citation
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.
Results Reference
result
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Antibacterial Effectiveness of Two Root Canal Irrigants
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