ICG-PDT, Periimplantitis, Diabetes Mellitus

Phase 1

Completed

• Conditions: Peri-Implantitis
• Interventions: Biological: ICG-PDT; Device: peri-implant mechanical debridement

• Registration Number: NCT04833569
• Lead Sponsor: King Saud University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-20
• Primary Completion: 2021-02-15
• Study Completion: 2021-03-10
• Study First Submitted: 2021-03-30
• Status Verified: 2021-04
• Study First Submitted QC: 2021-04-04
• Last Update Submitted: 2021-04-04
• Study First Posted: 2021-04-06
• Last Update Posted: 2021-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Indocyanine green mediated photodynamic therapy (ICG-PDT)	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.
Peri-implant mechanical debridement	peri-implant mechanical debridement	Non-surgical peri-implant mechanical debridement (PIMD) through ultrasonic device with a carbon tip.
Indocyanine green mediated photodynamic therapy (ICG-PDT)	peri-implant mechanical debridement	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

King Saud University; 🇸🇦 Riyadh, Saudi Arabia