ICG-PDT, Periimplantitis, Diabetes Mellitus

King Saud University50 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Peri-Implantitis

Interventions

ICG-PDTBIOLOGICAL

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

peri-implant mechanical debridementDEVICE

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

Eligibility

Sex: ALLMin age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

* 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.

Locations (1)

King Saud University

Riyadh, Saudi Arabia

Outcomes

Primary Outcomes

Bleeding on probing

Presence or absence of bleeding indicated as '1' or '0', respectively

Time frame: 6 months

Plaque index

Presence or absence of plaque indicated as '1' or '0', respectively.

Time frame: 6 months

Probing depth

Measurement of consecutive millimeter markings of the periodontal pocket depth

Time frame: 6 months

Suppuration

Presence or absence of pus

Time frame: 6 months

Crestal bone loss

Measurement of consecutive millimeter markings of the alveolar bone levels

Time frame: 6 months

Secondary Outcomes

Microbiological analysis (Porphyromonas gingivalis)

Bacterial viability from the peri-implant plaque

Time frame: 6 months

Microbiological analysis (Treponema denticola)

Bacterial viability from the peri-implant plaque

Time frame: 6 months

HbA1c

Assessment of serum HbA1c

Time frame: 6 months

Interleukin-1 beta

Assessment from peri-implant crevicular fluid

Time frame: 6 months

Data from ClinicalTrials.gov

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