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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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04833569
Enrollment
50
Registered
2021-04-06
Start date
2020-09-20
Completion date
2021-03-10
Last updated
2021-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peri-Implantitis

Keywords

photodynamic therapy*, periimplantitis*, diabetes mellitus*, indocyanine green*, photosensitizer*

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

Interventions

BIOLOGICALICG-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

DEVICEperi-implant mechanical debridement

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

Sponsors

King Saud University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
Yes

Inclusion 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.

Design outcomes

Primary

MeasureTime frameDescription
Suppuration6 monthsPresence or absence of pus
Crestal bone loss6 monthsMeasurement of consecutive millimeter markings of the alveolar bone levels
Bleeding on probing6 monthsPresence or absence of bleeding indicated as '1' or '0', respectively
Plaque index6 monthsPresence or absence of plaque indicated as '1' or '0', respectively.
Probing depth6 monthsMeasurement of consecutive millimeter markings of the periodontal pocket depth

Secondary

MeasureTime frameDescription
Microbiological analysis (Porphyromonas gingivalis)6 monthsBacterial viability from the peri-implant plaque
Microbiological analysis (Treponema denticola)6 monthsBacterial viability from the peri-implant plaque
HbA1c6 monthsAssessment of serum HbA1c
Interleukin-1 beta6 monthsAssessment from peri-implant crevicular fluid
Interleukin-66 monthsAssessment from peri-implant crevicular fluid

Countries

Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026