ICG-PDT, Periimplantitis, Diabetes Mellitus

Study Overview
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Brief Summary
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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

Official Title
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Clinical, Bacterial, and Inflammatory Outcomes of Indocyanine Green-mediated Photodynamic Therapy for Treating Periimplantitis Among Diabetic Patients: a Randomized Controlled Clinical Trial

Conditions
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Peri-Implantitis

Intervention / Treatment
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* Biological: ICG-PDT
* Device: peri-implant mechanical debridement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patients above 45 years of age having type 2 DM 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. 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.

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Indocyanine green mediated photodynamic therapy (ICG-PDT)<br>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. | Biological: ICG-PDT<br>* 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<br>Device: peri-implant mechanical debridement<br>* The peri-implant mechanical debridement was done with the help of ultrasonic carbon tip (Vector, Durr Dental, Bietigheim-Bissingen, Germany).<br>|
| Placebo Comparator: Peri-implant mechanical debridement<br>Non-surgical peri-implant mechanical debridement (PIMD) through ultrasonic device with a carbon tip. | Device: peri-implant mechanical debridement<br>* The peri-implant mechanical debridement was done with the help of ultrasonic carbon tip (Vector, Durr Dental, Bietigheim-Bissingen, Germany).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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photodynamic therapy*, periimplantitis*, diabetes mellitus*, indocyanine green*, photosensitizer*