ICG-PDT, Periimplantitis, Diabetes Mellitus

King Saud University

Status and phase: Completed; Phase 1

Conditions: Peri-Implantitis

Treatments: Device: peri-implant mechanical debridement; Biological: ICG-PDT

Study type: Interventional

Funder types: Other

Identifiers

NCT04833569

KingSaud

Details and patient eligibility

About

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

Enrollment: 50 patients

Sex: All

Ages: 45+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups, including a placebo group

Indocyanine green mediated photodynamic therapy (ICG-PDT)

Experimental group

Description:

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.

Treatment:

Device: peri-implant mechanical debridement

Biological: ICG-PDT

Peri-implant mechanical debridement

Placebo Comparator group

Description:

Non-surgical peri-implant mechanical debridement (PIMD) through ultrasonic device with a carbon tip.

Treatment:

Device: peri-implant mechanical debridement