Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
50 participants
INTERVENTIONAL
2020-09-20
2021-03-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Indocyanine green mediated photodynamic therapy (ICG-PDT)
Delivery of ICG solution at a concentration of 1 mg/mL will be used. The photosensitizer will be applied until the bottom of the peri-implant pocket using a 1 ml syringe. An 810 nm diode laser (A.R.C. laser GmbH, Nurnberg, Germany) with a power of 200 mW (continuous mode) and total energy of 4 J will be used to excite the ICG by starting from the papilla for 30 s followed by the insertion inside the peri-implant pocket depth for 10 s from both buccal and lingual side moving to coronal direction.
ICG-PDT
An 810 nm diode laser (A.R.C. laser GmbH, Nurnberg, Germany) with a power of 200 mW (continuous mode) and total energy of 4 J was used to excite the ICG by starting from the papilla for 30 s followed by the insertion inside the peri-implant pocket depth for 10 s from both buccal and lingual side moving to coronal direction. The treatment was applied according to the manufacturer's recommendation. The PDT was performed by a single operator in all test patients
peri-implant mechanical debridement
The peri-implant mechanical debridement was done with the help of ultrasonic carbon tip (Vector, Durr Dental, Bietigheim-Bissingen, Germany).
Peri-implant mechanical debridement
Non-surgical peri-implant mechanical debridement (PIMD) through ultrasonic device with a carbon tip.
peri-implant mechanical debridement
The peri-implant mechanical debridement was done with the help of ultrasonic carbon tip (Vector, Durr Dental, Bietigheim-Bissingen, Germany).
Interventions
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ICG-PDT
An 810 nm diode laser (A.R.C. laser GmbH, Nurnberg, Germany) with a power of 200 mW (continuous mode) and total energy of 4 J was used to excite the ICG by starting from the papilla for 30 s followed by the insertion inside the peri-implant pocket depth for 10 s from both buccal and lingual side moving to coronal direction. The treatment was applied according to the manufacturer's recommendation. The PDT was performed by a single operator in all test patients
peri-implant mechanical debridement
The peri-implant mechanical debridement was done with the help of ultrasonic carbon tip (Vector, Durr Dental, Bietigheim-Bissingen, Germany).
Eligibility Criteria
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Inclusion Criteria
* HbA1c (≥6.5%) and fasting glucose test
* probing depth ≥6 mm with bleeding and/or suppuration on at least one site around dental implants that remained in situ
* On radiographic assessment, the implants exhibited ≥ 3 mm alveolar bone loss apical to the coronal region of the intraosteal portion of the dental implant.
45 Years
ALL
Yes
Sponsors
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King Saud University
OTHER
Responsible Party
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Labban Nawwaf
Department of Prosthetic Dental Sciences, College of Dentistry, King Saud University
Principal Investigators
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Nawwaf Labban, BDS MSD PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Prosthetic Dental Sciences, College of Dentistry, King Saud University
Locations
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King Saud University
Riyadh, , Saudi Arabia
Countries
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References
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Labban N, Shibani NA, Al-Kattan R, Alfouzan AF, Binrayes A, Assery MK. Clinical, bacterial, and inflammatory outcomes of indocyanine green-mediated photodynamic therapy for treating periimplantitis among diabetic patients: A randomized controlled clinical trial. Photodiagnosis Photodyn Ther. 2021 Sep;35:102350. doi: 10.1016/j.pdpdt.2021.102350. Epub 2021 May 24.
Other Identifiers
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KingSaud
Identifier Type: -
Identifier Source: org_study_id
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