NCT05242354

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 16, 2022

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

May 18, 2023

Completed
Last Updated

May 18, 2023

Status Verified

May 1, 2023

Enrollment Period

10 months

First QC Date

January 28, 2022

Results QC Date

March 21, 2022

Last Update Submit

May 16, 2023

Conditions

Peri-ImplantitisPeriodontitis

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • CD80/CD163 Ratio

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

    Baseline

  • CD80/CD206 Ratio

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

    Baseline

Secondary Outcomes (1)

  • Probing Depth

    Baseline

Study Arms (4)

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 -

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

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 +

Peri-implantitis

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Otherwise healthy periodontitis, peri-implantitis patients or periodontally healthy individuals who applied to Biruni University Dentistry Faculty for treatment / regular oral examination

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biruni University

Istanbul, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tissue samples

MeSH Terms

Conditions

Peri-ImplantitisPeriodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Results Point of Contact

Title
Dr Mustafa YILMAZ
Organization
Biruni University
myilmaz@biruni.edu.tr
+90 533 7129952

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst Prof

Study Record Dates

First Submitted

January 28, 2022

First Posted

February 16, 2022

Study Start

March 1, 2021

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

May 18, 2023

Results First Posted

May 18, 2023

Record last verified: 2023-05

Locations

TU(1)