Periradicular DiseasePhase 2NCT02555488
Comparing the Antibacterial Effect of 810 nm Diode Laser and Photodynamic Therapy
A Phase 2 study testing diode laser and Methylene blue in people with Periradicular Disease, run by Shahid Beheshti University at 1 site in Iran.
Trial summary
The aim of this study was to compare the Antibacterial Efficacy of Diode Laser 810nm and Photodynamic therapy in reducing bacterial microflora in endodontic retreatment of teeth with periradicular lesion. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Periradicular Disease
- What is being tested?
- diode laser and Methylene blue
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIran
- Study dates
- Jan 2015to Dec 2015
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- endodontic retreatment of teeth with periradicular lesion.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Shahid Beheshti University
Tehran
mohammad asnaashari, 09190129151
About this study
Official title: Comparing the Antibacterial Effect of 810 nm Diode Laser and Photodynamic Therapy in Reducing the Microbial Flora of the Canal While Root Retreatment in Patients With Periradicular Lesions
The aim of this study was to compare the Antibacterial Efficacy of Diode Laser 810nm and Photodynamic therapy in reducing bacterial microflora in endodontic retreatment of teeth with periradicular lesion.
Read the detailed description
Conventional techniques of root canal treatments such as mechanical instrumentation and chemical debridement with antimicrobial irrigants, such as Sodium hypochlorite (NaOCl) and chlorhexidine and use of calcium hydroxide do not always suffice to predictably render root canals free of bacteria Using the high-power diode laser is a new approach of disinfection allowing access to the previously unavailable areas, such as the tubular network. This study, therefore, compares two types of diode lasers (low-power and high power) in terms of anti-bacterial effect as well as the conventional endodontic retreatment to determine the ideal method of root canal disinfection.
- Conditions
- Periradicular Disease
- Being tested
- diode laser, Methylene blue
- Medical subject headings
- Periapical Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diode laserDevice
MB and diode
diode laserDevice
diode laser
Methylene blueDrug
Methylene blue and diode laser was used
| Study group | Role | What they receive |
|---|---|---|
| 2 | Experimental | in the second group diode laser (810 nm, 1.2 W, 30 s) was irradiated. Then second samples were taken from all canals. Receives: Device: diode laser |
| 1 | Experimental | In the first group Photodynamic therapy (PDT) with Methylene blue and diode laser (810 nm, 0.2 W, 40 second) was done Receives: Device: diode laser; Drug: Methylene blue |
What is being measured
The primary outcome is the main question the study is designed to answer.
bacterial colony forming unit(CFU/ML)
after doing protocol in each groups CFU /ml for different bacteria will be counted
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2015 (estimated)
- Study startJan 2015
- Primary completionOct 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periradicular DiseaseStudies 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
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, saranaz azari-marhabi, Shahid Beheshti University
- Investigators
- saranaz azari-marhabi, DMD, Principal investigator, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02555488
- Sponsor's protocol ID
- shahid beheshti university
- Status last verified
- Sep 2015
- First submitted
- 15 Sep 2015
- Last updated
- 21 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Antibacterial Effect of 810 nm Diode Laser and Photodynamic Therapy in Reducing the Microbial Flora of the Canal While Root Retreatment in Patients With Periradicular Lesions
- ClinicalTrials.gov ID
- NCT02555488
- Acronym / sponsor ID
- shahid beheshti university
- Conditions
- Periradicular Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shahid Beheshti UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 21 Sep 2015 (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 study was to compare the Antibacterial Efficacy of Diode Laser 810nm and Photodynamic therapy in reducing bacterial microflora in endodontic retreatment of teeth with periradicular lesion.
Detailed description
Conventional techniques of root canal treatments such as mechanical instrumentation and chemical debridement with antimicrobial irrigants, such as Sodium hypochlorite (NaOCl) and chlorhexidine and use of calcium hydroxide do not always suffice to predictably render root canals free of bacteria Using the high-power diode laser is a new approach of disinfection allowing access to the previously unavailable areas, such as the tubular network. This study, therefore, compares two types of diode lasers (low-power and high power) in terms of anti-bacterial effect as well as the conventional endodontic retreatment to determine the ideal method of root canal disinfection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Experimental | Device: diode laserin the second group diode laser (810 nm, 1.2 W, 30 s) was irradiated. Then second samples were taken from all canals. |
| 1 | Experimental | Device: diode laser, Drug: Methylene blueIn the first group Photodynamic therapy (PDT) with Methylene blue and diode laser (810 nm, 0.2 W, 40 second) was done |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- endodontic retreatment of teeth with periradicular lesion.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| diode laserMB and diode | Device | 1 |
| diode laserdiode laser | Device | 2 |
| Methylene blueMethylene blue and diode laser was used | Drug | 1 |
Primary outcome
bacterial colony forming unit(CFU/ML)
Time frame: 12 months
after doing protocol in each groups CFU /ml for different bacteria will be counted
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2015.
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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.
saranaz azari-marhabi, DMD principal investigator
Shahid Beheshti University of Medical Sciences
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 diode laser and Methylene blue in people with Periradicular Disease, run by Shahid Beheshti University at 1 site in Iran.
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: status not confirmed, as of the sponsor's last update on 21 Sep 2015. 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 Iran. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact saranaz azari-marhabi, DMD (09190129151, saranazazari@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bacterial colony forming unit(CFU/ML) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2015.