ICG-PDT, Periimplantitis, Diabetes Mellitus

Overview

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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: February 15, 2021

Interventions

  • Biological: 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
  • Device: peri-implant mechanical debridement
    • The peri-implant mechanical debridement was done with the help of ultrasonic carbon tip (Vector, Durr Dental, Bietigheim-Bissingen, Germany).

Arms, Groups and Cohorts

  • Experimental: 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.
  • Placebo Comparator: Peri-implant mechanical debridement
    • Non-surgical peri-implant mechanical debridement (PIMD) through ultrasonic device with a carbon tip.

Clinical Trial Outcome Measures

Primary Measures

  • Bleeding on probing
    • Time Frame: 6 months
    • Presence or absence of bleeding indicated as ‘1’ or ‘0’, respectively
  • Plaque index
    • Time Frame: 6 months
    • Presence or absence of plaque indicated as ‘1’ or ‘0’, respectively.
  • Probing depth
    • Time Frame: 6 months
    • Measurement of consecutive millimeter markings of the periodontal pocket depth
  • Suppuration
    • Time Frame: 6 months
    • Presence or absence of pus
  • Crestal bone loss
    • Time Frame: 6 months
    • Measurement of consecutive millimeter markings of the alveolar bone levels

Secondary Measures

  • Microbiological analysis (Porphyromonas gingivalis)
    • Time Frame: 6 months
    • Bacterial viability from the peri-implant plaque
  • Microbiological analysis (Treponema denticola)
    • Time Frame: 6 months
    • Bacterial viability from the peri-implant plaque
  • HbA1c
    • Time Frame: 6 months
    • Assessment of serum HbA1c
  • Interleukin-1 beta
    • Time Frame: 6 months
    • Assessment from peri-implant crevicular fluid
  • Interleukin-6
    • Time Frame: 6 months
    • Assessment from peri-implant crevicular fluid

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 45 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • King Saud University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Labban Nawwaf, Department of Prosthetic Dental Sciences, College of Dentistry, King Saud University – King Saud University
  • Overall Official(s)
    • Nawwaf Labban, BDS MSD PhD, Principal Investigator, Department of Prosthetic Dental Sciences, College of Dentistry, King Saud University

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