Macrophage Markers in Periodontal and Peri-implant Health and Disease

NCT ID: NCT05242354

Last Updated: 2023-05-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-01

Study Completion Date

2021-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Peri-Implantitis Periodontitis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Periodontal health

Periodontally healthy individuals (2017 Classification of Periodontal Diseases and Conditions) who are planned to receive crown lengthening / gingivectomy of tooth extraction involving at least one site with pocket depth ≤3mm, bleeding on probing -

No interventions assigned to this group

Peri-implant health

Periodontally healthy individuals (2017 Classification of Periodontal Diseases and Conditions) with at least one partially-exposed dental implant with no bone loss prior to the prosthetic rehabilitation

No interventions assigned to this group

Periodontitis

Generalized Stage III Grade C periodontitis patients (2017 Classification of Periodontal Diseases and Conditions) having at least one site with pocket depth ≥6mm, bleeding on probing +

No interventions assigned to this group

Peri-implantitis

Individuals with at least one implant site with radiographic bone loss, pocket depth ≥6mm and bleeding on probing +

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Turku

OTHER

Sponsor Role collaborator

Biruni University

OTHER

Sponsor Role lead

Responsible Party

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Mustafa YILMAZ

Asst Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Biruni University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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Peri-implant macrophage

Identifier Type: -

Identifier Source: org_study_id

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