ICG-PDT, Periimplantitis, Diabetes Mellitus

Peri-Implantitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04833569
• Other study ID #: KingSaud
• Status: Completed
• Phase: Phase 1
• Start date: September 20, 2020
• Est. completion date: March 10, 2021

Study information

• Verified date: April 2021
• Source: King Saud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 10, 2021
• Est. primary completion date: February 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years and older

Eligibility

• 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.

Related Conditions & MeSH terms

• Peri-Implantitis

Intervention

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).

Locations

Country	Name	City	State
Saudi Arabia	King Saud University	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
King Saud University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bleeding on probing	Presence or absence of bleeding indicated as '1' or '0', respectively	6 months
Primary	Plaque index	Presence or absence of plaque indicated as '1' or '0', respectively.	6 months
Primary	Probing depth	Measurement of consecutive millimeter markings of the periodontal pocket depth	6 months
Primary	Suppuration	Presence or absence of pus	6 months
Primary	Crestal bone loss	Measurement of consecutive millimeter markings of the alveolar bone levels	6 months
Secondary	Microbiological analysis (Porphyromonas gingivalis)	Bacterial viability from the peri-implant plaque	6 months
Secondary	Microbiological analysis (Treponema denticola)	Bacterial viability from the peri-implant plaque	6 months
Secondary	HbA1c	Assessment of serum HbA1c	6 months
Secondary	Interleukin-1 beta	Assessment from peri-implant crevicular fluid	6 months
Secondary	Interleukin-6	Assessment from peri-implant crevicular fluid	6 months