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In this study, the effect of photodynamic therapy (indocyanine green mediated) on the clinical, biological and inflammatory aspects was assessed in diabetic patients having peri-implantitis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Indocyanine green mediated photodynamic therapy (ICG-PDT) | Experimental | 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. |
|
| Peri-implant mechanical debridement | Placebo Comparator | Non-surgical peri-implant mechanical debridement (PIMD) through ultrasonic device with a carbon tip. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICG-PDT | Biological | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding on probing | Presence or absence of bleeding indicated as '1' or '0', respectively | 6 months |
| Plaque index | Presence or absence of plaque indicated as '1' or '0', respectively. | 6 months |
| Probing depth | Measurement of consecutive millimeter markings of the periodontal pocket depth | 6 months |
| Suppuration | Presence or absence of pus | 6 months |
| Crestal bone loss | Measurement of consecutive millimeter markings of the alveolar bone levels | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Microbiological analysis (Porphyromonas gingivalis) | Bacterial viability from the peri-implant plaque | 6 months |
| Microbiological analysis (Treponema denticola) | Bacterial viability from the peri-implant plaque |
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Inclusion Criteria:
Exclusion Criteria Patients were excluded if they indicated current or former history of tobacco smoking, any systemic disease other than DM, enrolled in a non-surgical periodontal maintenance program, history of implant repair, pregnancy, and part six months use of antimicrobials, non-steroidal anti-inflammatory drugs, bisphosphonates, or corticosteroids.
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| Name | Affiliation | Role |
|---|---|---|
| Nawwaf Labban, BDS MSD PhD | Department of Prosthetic Dental Sciences, College of Dentistry, King Saud University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Saud University | Riyadh | 11564 | Saudi Arabia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34033934 | Derived | 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. |
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| ID | Term |
|---|---|
| D057873 | Peri-Implantitis |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D044882 | Glucose Metabolism Disorders |
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|
| peri-implant mechanical debridement | Device | The peri-implant mechanical debridement was done with the help of ultrasonic carbon tip (Vector, Durr Dental, Bietigheim-Bissingen, Germany). |
|
| 6 months |
| HbA1c | Assessment of serum HbA1c | 6 months |
| Interleukin-1 beta | Assessment from peri-implant crevicular fluid | 6 months |
| Interleukin-6 | Assessment from peri-implant crevicular fluid | 6 months |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |