Efficacy of Adjunctive Antimicrobial Photodynamic Therapy for Residual Pockets in Previously Surgically Treated Teeth
NCT ID: NCT03757260
Last Updated: 2019-10-01
Study Results
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Basic Information
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UNKNOWN
NA
24 participants
INTERVENTIONAL
2019-01-08
2020-08-31
Brief Summary
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Detailed Description
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Once selected the patient will see two clinicians: the examiner (hygienist) and operator (resident).
The examiner records the data (PPD, CAL, BOP, PI) of the entire dentition including the selected tooth or teeth, and provides preliminary hygiene treatment; the operator delivers the test treatments.
The treatment assignments are concealed to the patient and the examiner. The operator is unaware of previously recorded data except for pocket depth measurements and is not involved in the post-treatment evaluations (3,6,12 months). At 12 months, a full mouth re-evaluation will be completed by the examiner as part of the patient's maintenance program.
In the first visit, the examiner records the pocket probing depth, clinical attachment level, presence of bleeding on probing, and plaque index at six sites on involved teeth. Thorough scaling and root planing is performed under local anesthesia using periodontal curettes (Gracey, Hu-Friedy, USA) and an ultrasonic device (Piezo, Ultradent, USA). Once complete, the operator takes over. The patients are then randomly assigned to test or control groups by a computer-generated table. The protocol may be: A, the laser is activated during treatments with methylene blue; B, the laser is never activated during treatments with saline solution.
Antimicrobial photodynamic therapy is carried out in the residual pockets using the Periowave system (Ondine Biomedical Inc, Vancouver, Canada). The photosensitizing agent is methylene blue. Approximately 0.2 mL of the solution is applied over 60 seconds to each pocket with a blunt-ended side-port irrigator. The site is illuminated for 60 seconds to activate the agent using a disposable, light-diffusing tip that is introduced into the pocket via a diode laser (wavelength = 675 nm, 160 mW of output power). The control treatment consists of the same procedure, except that the photosensitizer is replaced with saline solution and the light-diffusing tip is kept in the pocket for 60 seconds without activating the laser. The patient is sent home with a home care package and oral hygiene instructions.
The second session is scheduled after 1 week. The operator applies the photosensitizer and activates the laser according to protocol A or B. The examiner maintains the patients on a 3-month hygiene schedule and reassesses the participants 3, 6, and 12 months after the treatment as well as reinforces oral hygiene instruction. Medical history, concomitant medication, and all adverse events are recorded. Clinical parameters are measured the same way as at baseline. All measurements will be calibrated.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
The examiner records the data (PPD, CAL, BOP, PI) of the teeth, and provides preliminary hygiene treatment; the operator delivers the test treatments.
The treatment assignments are concealed to the patient and the examiner. The operator is unaware of previously recorded data except for pocket depth measurements and is not involved in the post-treatment evaluations (3,6,12 months)
Study Groups
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Treatment Group
Antimicrobial photodynamic therapy with methylene blue applied to test site after mechanical debridement.
Antimicrobial photodynamic therapy
Antimicrobial photodynamic therapy is carried out in the residual pockets using the Periowave system. The photosensitizing agent is methylene blue. Approximately 0.2 mL of the solution is applied over 60 seconds to each pocket with a blunt-ended side-port irrigator. The site is illuminated for 60 seconds to activate the agent using a disposable, light-diffusing tip that is introduced into the pocket via a diode laser (wavelength = 675 nm, 160 mW of output power).
Placebo Group
Photodynamic therapy laser is not activated with saline water in the test site after mechanical debridement.
Placebo of photodynamic therapy
The placebo of the antimicrobial photodynamic therapy is carried out in the residual pockets using the Periowave system. The photosensitizing agent is saline solution. Approximately 0.2 mL of the solution is applied over 60 seconds to each pocket with a blunt-ended side-port irrigator. The site is not illuminated (falsely activated) for 60 seconds using a disposable, light-diffusing tip that is introduced into the pocket via a diode laser (wavelength = 675 nm, 160 mW of output power).
Interventions
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Antimicrobial photodynamic therapy
Antimicrobial photodynamic therapy is carried out in the residual pockets using the Periowave system. The photosensitizing agent is methylene blue. Approximately 0.2 mL of the solution is applied over 60 seconds to each pocket with a blunt-ended side-port irrigator. The site is illuminated for 60 seconds to activate the agent using a disposable, light-diffusing tip that is introduced into the pocket via a diode laser (wavelength = 675 nm, 160 mW of output power).
Placebo of photodynamic therapy
The placebo of the antimicrobial photodynamic therapy is carried out in the residual pockets using the Periowave system. The photosensitizing agent is saline solution. Approximately 0.2 mL of the solution is applied over 60 seconds to each pocket with a blunt-ended side-port irrigator. The site is not illuminated (falsely activated) for 60 seconds using a disposable, light-diffusing tip that is introduced into the pocket via a diode laser (wavelength = 675 nm, 160 mW of output power).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Enrolled in a supportive periodontal therapy program and a patient at the University of Manitoba Graduate Periodontics Clinic
* At least one surgically treated periodontal site with a residual pocket probing depth of ≥ 5mm and bleeding upon probing
* Completed informed consent
Exclusion Criteria
* Patients with cancer
* Patients with HIV
* Patients with bone metabolic diseases
* Patients with disorders that compromise wound healing
* Patients undergoing radiation or immunosuppressive therapy
* Pregnancy or lactation
* Have had antibiotics therapy within the last three months
* Confirmed or suspected intolerance to methylene blue
* Any physical limitations or restrictions that might preclude normal oral hygiene procedures
18 Years
ALL
Yes
Sponsors
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University of Manitoba
OTHER
Responsible Party
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Javier Cabrales
Principal Investigator
Principal Investigators
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Anastasia Cholakis, M Dent
Role: STUDY_DIRECTOR
University of Manitoba
Locations
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University of Manitoba
Winnipeg, Manitoba, Canada
Countries
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References
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Other Identifiers
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B2018:012
Identifier Type: -
Identifier Source: org_study_id
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