Periapical PeriodontitisPhase 2NCT02747082
Antibacterial Effectiveness of Two Root Canal Irrigants
A Phase 2 study testing Retreatment of root-filled teeth with infection in people with Periapical Periodontitis, run by University of Oslo at 1 site in Norway.
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). Read more about this study
- Who is it for?
- Ages 20 to 95 years
- Conditions the study is for
- Periapical Periodontitis
- What is being tested?
- Retreatment of root-filled teeth with infection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2012to Jan 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of apical periodontitis in a root-filled tooth assessed by radiography.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Periapical Periodontitis
- Being tested
- Retreatment of root-filled teeth with infection
- Keywords
- endodontic retreatment, sodium hypochlorite, chlorhexidine, calcium hydroxide, Retreatment
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retreatment of root-filled teeth with infectionProcedure or surgery
Root-filled teeth with infection are being treated with either 1% NaOCl or 2% CHX as disinfection irrigation solution.
| Study group | Role | What they receive |
|---|---|---|
| 1% sodium hypochlorite (NaOCl) | Active comparator | 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). Receives: Procedure: Retreatment of root-filled teeth with infection |
| 2% chlorhexidine gluconate (CHX) | Active comparator | 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). Receives: Procedure: Retreatment of root-filled teeth with infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periapical radiolucency (PAI- and Friedman-scores)
Measured: 12 months
Secondary outcomes (2)
Bacterial load assessed by qPCR
Measured: 21 days
Pyrosequencing of species found before and after the intervention
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study startJan 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Periapical PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade Estácio de Sá
- Responsible party
- Principal investigator, Homan Zandi, University of Oslo
- Investigators
- Dag MR Ørstavik, DDS, PhD, Study chair, Chair of the endodontic department, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02747082
- Sponsor's protocol ID
- 2012/364/REK
- Status last verified
- Apr 2016
- First submitted
- 21 Mar 2016
- Last updated
- 21 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
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.
PubMed 21238793
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibacterial Effectiveness of Two Root Canal Irrigants in Root-filled Teeth With Infection: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02747082
- Acronym / sponsor ID
- 2012/364/REK
- Conditions
- Periapical Periodontitis
- Keywords
- endodontic retreatment, sodium hypochlorite, chlorhexidine, calcium hydroxide, Retreatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Collaborators
- Universidade Estácio de Sá
- Study start
- Jan 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 21 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1% sodium hypochlorite (NaOCl) | Active comparator | Procedure: Retreatment of root-filled teeth with infectionRetreatment 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). |
| 2% chlorhexidine gluconate (CHX) | Active comparator | Procedure: Retreatment of root-filled teeth with infectionRetreatment 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). |
Who may qualify
- Ages
- 20 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of apical periodontitis in a root-filled tooth assessed by radiography.
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retreatment of root-filled teeth with infectionRoot-filled teeth with infection are being treated with either 1% NaOCl or 2% CHX as disinfection irrigation solution. | Procedure or surgery | 1% sodium hypochlorite (NaOCl), 2% chlorhexidine gluconate (CHX) |
Primary outcome
Periapical radiolucency (PAI- and Friedman-scores)
Time frame: 12 months
2 secondary outcomes
Bacterial load assessed by qPCR
Time frame: 21 days
Pyrosequencing of species found before and after the intervention
Time frame: 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2016.
- Results publication: PubMed 21238793Rocas 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.
- Individual participant dataSharing planned: Yes
Related trials for Periapical Periodontitis
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Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
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Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
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Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
Not yet recruiting
PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
Pulp Necrosis, Apical Periodontitis
Not yet recruiting
Influence of Continuous Rotation Versus Reciprocation Motion of MG3 Blue Rotary File on Postoperative Pain and Intracanal Bacterial Reduction of Teeth With Necrotic Pulps.
Necrotic Pulps With no Apical Periodontitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dag MR Ørstavik, DDS, PhD study chair
Chair of the endodontic department, University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Retreatment of root-filled teeth with infection in people with Periapical Periodontitis, run by University of Oslo at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periapical radiolucency (PAI- and Friedman-scores) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02747082, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2016.