ICG-PDT, Periimplantitis, Diabetes Mellitus

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

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

Study Overview

• Status: Completed
• Conditions: Peri-Implantitis
• Intervention / Treatment: Biological: ICG-PDT; Device: peri-implant mechanical debridement

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 1

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia, 11564
    • King Saud University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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).
Placebo Comparator: Peri-implant mechanical debridement; Non-surgical peri-implant mechanical debridement (PIMD) through ultrasonic device with a carbon tip.	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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: King Saud University
• Investigators: Principal Investigator: Nawwaf Labban, BDS MSD PhD, Department of Prosthetic Dental Sciences, College of Dentistry, King Saud University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2020
• Primary Completion (Actual): February 15, 2021
• Study Completion (Actual): March 10, 2021

Study Registration Dates

• First Submitted: March 30, 2021
• First Submitted That Met QC Criteria: April 4, 2021
• First Posted (Actual): April 6, 2021

Study Record Updates

• Last Update Posted (Actual): April 6, 2021
• Last Update Submitted That Met QC Criteria: April 4, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: photodynamic therapy*; periimplantitis*; diabetes mellitus*; indocyanine green*; photosensitizer*
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Peri-Implantitis
• Other Study ID Numbers: KingSaud

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No