Macrophage Markers in Periodontal and Peri-implant Health and Disease

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05242354
• Other study ID #: Peri-implant macrophage
• Status: Completed
• Start date: March 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: May 2023
• Source: Biruni University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peri-Implantitis
• Periodontitis

Locations

Country	Name	City	State
Turkey	Biruni University	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Biruni University	University of Turku

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CD80	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.	Baseline
Primary	CD163	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.	Baseline
Primary	CD206	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.	Baseline
Primary	CD80/CD163 Ratio	Tissue levels (Western Blot assay analyzed using Image J software) of CD80 divided by those of CD163	Baseline
Primary	CD80/CD206 Ratio	Tissue levels (Western Blot assay analyzed using Image J software) of CD80 divided by those of CD206	Baseline
Secondary	Probing Depth	Probing depth of each site, where the tissue sample was harvested. The average probing depth of sites in each group are presented.	Baseline