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Completed

NCT Number: NCT04833569

ICG-PDT, Periimplantitis, Diabetes Mellitus

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

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Key information

Conditions

Peri-implantitis Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Mouth Diseases Nutritional and Metabolic Diseases Periodontal Diseases Stomatognathic Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

King Saud University

Riyadh, 11564, Saudi Arabia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

ICG-PDT

Biological

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 debridement

Device

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

Primary outcomes

  1. Bleeding on probing

    Time frame: 6 months

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

  2. Plaque index

    Time frame: 6 months

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

  3. Probing depth

    Time frame: 6 months

    Measurement of consecutive millimeter markings of the periodontal pocket depth

  4. Suppuration

    Time frame: 6 months

    Presence or absence of pus

  5. Crestal bone loss

    Time frame: 6 months

    Measurement of consecutive millimeter markings of the alveolar bone levels

Secondary outcomes

  1. Microbiological analysis (Porphyromonas gingivalis)

    Time frame: 6 months

    Bacterial viability from the peri-implant plaque

  2. Microbiological analysis (Treponema denticola)

    Time frame: 6 months

    Bacterial viability from the peri-implant plaque

  3. HbA1c

    Time frame: 6 months

    Assessment of serum HbA1c

  4. Interleukin-1 beta

    Time frame: 6 months

    Assessment from peri-implant crevicular fluid

  5. Interleukin-6

    Time frame: 6 months

    Assessment from peri-implant crevicular fluid

Sponsors and collaborators

Lead sponsor

King Saud University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 6, 2021
Registry last updated
Apr 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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