Root Canal InfectionNCT03750162
Bacteria Elimination in Retreatment Cases Using Different Disinfection Techniques
A study testing VDW Ultra, AMD picasso and ProtaperNext X3 gutta-percha in people with Root Canal Infection and Periapical; Infection, run by Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial summary
Nonsurgical root canal retreatment may become essential when the initial endodontic treatment fails because of the persistent intracanal or extracanal infections.It has been stated that the one of the main cause of posttreatment disease is the persistent or reintroduced microorganism such as enterococcus faecalis. Read more about this study
- Who is it for?
- Ages 14 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Root Canal Infection, Periapical; Infection
- What is being tested?
- VDW Ultra, AMD picasso and ProtaperNext X3 gutta-percha
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2017to 5 Sep 2017
- Phase
- Interventional
- 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 14 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with no clinical symptoms Endodontically treated teeth Single rooted teeth
Who cannot join
- Teeth with fractured instrument, resorption, perforation, ledge, over fillings Periodontal pockets deeper than 4 mm
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bulent Ecevit University Faculty of Dentistry Department of Endodontics
Zonguldak
About this study
Official title: Enterococcus Faecalis Elimination in Retreatment Cases Using Passive Ultrasonic Irrigation (PUI), Manual Dynamic Activation (MDA) and Photodynamic Therapy (PDT): a Randomized Clinical Trial
Nonsurgical root canal retreatment may become essential when the initial endodontic treatment fails because of the persistent intracanal or extracanal infections.It has been stated that the one of the main cause of posttreatment disease is the persistent or reintroduced microorganism such as enterococcus faecalis. Supplementary disinfection techniques such as irrigation agitation methods can help elimination of bacteria from root canal systems.
The aim of this in vivo study was to compare the effect of passive ultrasonic irrigation, manual dynamic activation and photodynamic therapy in reducing bacterial load in endodontic retreatment cases with periradicular lesion by using polymerase chain reaction (PCR)in a single visit root canal treatment.
Read the detailed description
Thirty-six teeth with a single root and a single canal with posttreatment apical periodontitis which needed retreatment were selected for this study. Teeth were randomly divided into 3 groups according to the supplementary disinfection techniques used: Passive ultrasonic irrigation, Manual dynamic activation and Photodynamic therapy. Microbiological samples were taken before any intervention, after conventional chemo-mechanical preparation, and after disinfection techniques with sterile paper points and held in thioglycollate broth, and then were transferred to the microbiological laboratory. The amounts of e.faecalis in these samples was measured by using PCR.
- Conditions
- Root Canal Infection, Periapical; Infection
- Being tested
- VDW Ultra, AMD picasso, ProtaperNext X3 gutta-percha
- Keywords
- photodynamic therapy, diode laser
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VDW UltraDevice
supplementary disinfection technique
AMD picassoDevice
supplementary disinfection technique
ProtaperNext X3 gutta-perchaDevice
supplementary disinfection technique
| Study group | Role | What they receive |
|---|---|---|
| Passive Ultrasonic irrigation | Experimental | Irrigation solution was ultrasonically activated in the canal for 1 minute by using IrriSafe tip coupled to an ultrasonic device with VDW Ultra . Receives: Device: VDW Ultra |
| Manuel dynamic activation | Experimental | Irrigation solution was activated with a well-fitting a ProtaperNext X3 gutta-percha point placed to working length was then moved in push - pull motions at a rate of 100 strokes/per minute Receives: Device: ProtaperNext X3 gutta-percha |
| Photodynamic Therapy | Experimental | Root canal was filled by 0.5 mL of 0.01% methylene blue (MB) solution for 5 minutes, then radiated by the light supply of a diode laser AMD picasso with a wavelength of 810 nm for 40 seconds (0.2 W). Receives: Device: AMD picasso |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacteria change
Bacteria samples were taken at 3 step; before any intervention, after chemomechanical preparation, and after applying supplementary disinfection techniques
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study start1 Feb 2017
- Primary completion15 Jun 2017
- Study completion5 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Root Canal InfectionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevinç Aktemur Türker, Bulent Ecevit University
- Investigators
- Sevinç Aktemur Türker, Study director, Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03750162
- Sponsor's protocol ID
- 2016-27194235-02
- Other IDs
- 2016
- Status last verified
- Nov 2018
- First submitted
- 18 Nov 2018
- Last updated
- 23 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Asnaashari M, Godiny M, Azari-Marhabi S, Tabatabaei FS, Barati M. Comparison of the Antibacterial Effect of 810 nm Diode Laser and Photodynamic Therapy in Reducing the Microbial Flora of Root Canal in Endodontic Retreatment in Patients With Periradicular Lesions. J Lasers Med Sci. 2016 Spring;7(2):99-104. doi: 10.15171/jlms.2016.17. Epub 2016 Mar 27.
PubMed 27330705Rodrigues RC, Antunes HS, Neves MA, Siqueira JF Jr, Rocas IN. Infection Control in Retreatment Cases: In Vivo Antibacterial Effects of 2 Instrumentation Systems. J Endod. 2015 Oct;41(10):1600-5. doi: 10.1016/j.joen.2015.06.005. Epub 2015 Jul 30.
PubMed 26234543
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enterococcus Faecalis Elimination in Retreatment Cases Using Passive Ultrasonic Irrigation (PUI), Manual Dynamic Activation (MDA) and Photodynamic Therapy (PDT): a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03750162
- Acronym / sponsor ID
- 2016-27194235-02
- Conditions
- Root Canal Infection, Periapical; Infection
- Keywords
- photodynamic therapy, diode laser
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 15 Jun 2017 (actual)
- Study completion
- 5 Sep 2017 (actual)
- First posted
- 21 Nov 2018 (actual)
- 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.
Nonsurgical root canal retreatment may become essential when the initial endodontic treatment fails because of the persistent intracanal or extracanal infections.It has been stated that the one of the main cause of posttreatment disease is the persistent or reintroduced microorganism such as enterococcus faecalis. Supplementary disinfection techniques such as irrigation agitation methods can help elimination of bacteria from root canal systems.
The aim of this in vivo study was to compare the effect of passive ultrasonic irrigation, manual dynamic activation and photodynamic therapy in reducing bacterial load in endodontic retreatment cases with periradicular lesion by using polymerase chain reaction (PCR)in a single visit root canal treatment.
Detailed description
Thirty-six teeth with a single root and a single canal with posttreatment apical periodontitis which needed retreatment were selected for this study. Teeth were randomly divided into 3 groups according to the supplementary disinfection techniques used: Passive ultrasonic irrigation, Manual dynamic activation and Photodynamic therapy. Microbiological samples were taken before any intervention, after conventional chemo-mechanical preparation, and after disinfection techniques with sterile paper points and held in thioglycollate broth, and then were transferred to the microbiological laboratory. The amounts of e.faecalis in these samples was measured by using PCR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Passive Ultrasonic irrigation | Experimental | Device: VDW UltraIrrigation solution was ultrasonically activated in the canal for 1 minute by using IrriSafe tip coupled to an ultrasonic device with VDW Ultra . |
| Manuel dynamic activation | Experimental | Device: ProtaperNext X3 gutta-perchaIrrigation solution was activated with a well-fitting a ProtaperNext X3 gutta-percha point placed to working length was then moved in push - pull motions at a rate of 100 strokes/per minute |
| Photodynamic Therapy | Experimental | Device: AMD picassoRoot canal was filled by 0.5 mL of 0.01% methylene blue (MB) solution for 5 minutes, then radiated by the light supply of a diode laser AMD picasso with a wavelength of 810 nm for 40 seconds (0.2 W). |
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with no clinical symptoms Endodontically treated teeth Single rooted teeth
Key exclusion criteria (1 listed)
- Teeth with fractured instrument, resorption, perforation, ledge, over fillings Periodontal pockets deeper than 4 mm
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 |
|---|---|---|
| VDW Ultrasupplementary disinfection technique | Device | Passive Ultrasonic irrigation |
| AMD picassosupplementary disinfection technique | Device | Photodynamic Therapy |
| ProtaperNext X3 gutta-perchasupplementary disinfection technique | Device | Manuel dynamic activation |
Primary outcome
Bacteria change
Time frame: 1 year
Bacteria samples were taken at 3 step; before any intervention, after chemomechanical preparation, and after applying supplementary disinfection techniques
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 23 Nov 2018.
- Background: PubMed 27330705Asnaashari M, Godiny M, Azari-Marhabi S, Tabatabaei FS, Barati M. Comparison of the Antibacterial Effect of 810 nm Diode Laser and Photodynamic Therapy in Reducing the Microbial Flora of Root Canal in Endodontic Retreatment in Patients With Periradicular Lesions. J Lasers Med Sci. 2016 Spring;7(2):99-104. doi: 10.15171/jlms.2016.17. Epub 2016 Mar 27.
- Background: PubMed 26234543Rodrigues RC, Antunes HS, Neves MA, Siqueira JF Jr, Rocas IN. Infection Control in Retreatment Cases: In Vivo Antibacterial Effects of 2 Instrumentation Systems. J Endod. 2015 Oct;41(10):1600-5. doi: 10.1016/j.joen.2015.06.005. Epub 2015 Jul 30.
- Individual participant dataSharing planned: No
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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.
Sevinç Aktemur Türker study director
Bulent Ecevit University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VDW Ultra, AMD picasso and ProtaperNext X3 gutta-percha in people with Root Canal Infection and Periapical; Infection, run by Bulent Ecevit University at 1 site in Turkey (Türkiye).
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 1 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 23 Nov 2018. 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 Turkey (Türkiye). 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.
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?
Bacteria change (time frame: 1 year). 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 NCT03750162, which also lists 2 linked publications.
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 23 Nov 2018; AzTrials last refreshed its copy on 29 Oct 2026.