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Completed

NCT Number: NCT05242354

Macrophage Markers in Periodontal and Peri-implant Health and Disease

Macrophage surface markers (CD80, CD163 and CD206) will be evaluated in periodontally healthy gingiva, healthy peri-implant mucosa, and periodontitis and peri-implantitis lesions.

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Key information

Conditions

Peri-implantitis Mouth Diseases Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Biruni University

Istanbul, Turkey (Türkiye)

About this study

Soft tissue biopsies obtained from clinically healthy gingiva, healthy peri-implant mucosa, Stage III Grade C periodontitis lesions and peri-implantitis lesions will be evaluated.

Healthy peri-implant samples are obtained from submerged implants during exposure surgery. Healthy gingiva samples are obtained from individuals receiving crown lengthening, gingivectomy or tooth extraction as excess tissue during the corresponding treatment. Samples from peri-implantitis and periodontitis (pocket depth ≥6 mm, bleeding on probing+) are obtained during initial periodontal treatment / debridement procedure with a single stroke at the pocket wall.

The samples will be grinded and ultrasonicated. Western blotting will be used for determination of CD80, CD163 and CD206 in biopsy specimens. ImageJ will be used for intensity analysis of the bands.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • diagnosed with generalized Grade C Stage III periodontitis
  • diagnosed with peri-implantitis
  • periodontally healthy individuals with dental implants in the primary healing period
  • periodontally healthy individuals who are in need of crown lengthening / gingivectomy or extraction

Exclusion criteria

  • systemic disease
  • smoking / former smokers
  • regular medicine intake
  • antibiotic or anti-inflammatory medicine intake in the last 3 months
  • pregnancy or lactation

Treatment and study plan

Primary outcomes

  1. CD80

    Time frame: Baseline

    Tissue levels of CD80

    Western Blot assay analyzed using Image J software:

    Following scanning for optical densitometry, the gels were analyzed with Image J software by obtaining profile plots, drawing lines enclosing the interest area and measuring the peak area of interest with the wand tool. The calculated optical density values are presented as arbitrary density units.

  2. CD163

    Time frame: Baseline

    Tissue levels of CD163

    Western Blot assay analyzed using Image J software:

    Following scanning for optical densitometry, the gels were analyzed with Image J software by obtaining profile plots, drawing lines enclosing the interest area and measuring the peak area of interest with the wand tool. The calculated optical density values are presented as arbitrary density units.

  3. CD206

    Time frame: Baseline

    Tissue levels of CD206

    Western Blot assay analyzed using Image J software (arbitrary density units):

    Following scanning for optical densitometry, the gels were analyzed with Image J software by obtaining profile plots, drawing lines enclosing the interest area and measuring the peak area of interest with the wand tool. The calculated optical density values are presented as arbitrary density units.

  4. CD80/CD163 Ratio

    Time frame: Baseline

    Tissue levels (Western Blot assay analyzed using Image J software) of CD80 divided by those of CD163

  5. CD80/CD206 Ratio

    Time frame: Baseline

    Tissue levels (Western Blot assay analyzed using Image J software) of CD80 divided by those of CD206

Secondary outcomes

  1. Probing Depth

    Time frame: Baseline

    Probing depth of each site, where the tissue sample was harvested. The average probing depth of sites in each group are presented.

Sponsors and collaborators

Lead sponsor

Biruni University

Other

Collaborators

  • University of Turku

Registry information

Official study title

CD80, CD163 and CD206 Tissue Levels in Periodontal and Peri-implant Health and Disease

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 16, 2022
Registry last updated
May 18, 2023

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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