Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Turku | OTHER |
Not provided
Not provided
Not provided
Not provided
Macrophage surface markers (CD80, CD163 and CD206) will be evaluated in periodontally healthy gingiva, healthy peri-implant mucosa, and periodontitis and peri-implantitis lesions.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 + |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Otherwise healthy periodontitis, peri-implantitis patients or periodontally healthy individuals who applied to Biruni University Dentistry Faculty for treatment / regular oral examination
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biruni University | Istanbul | Turkey (Türkiye) |
The investigators plan to share the data with other researchers who demand it.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 - |
| FG001 | 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 |
| FG002 | 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 + |
| FG003 | Peri-implantitis | Individuals with at least one implant site with radiographic bone loss, pocket depth ≥6mm and bleeding on probing + |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 - |
| BG001 | Peri-implant Health |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Median | 95% Confidence Interval | arbitrary density units | Baseline | periodontal/peri-implant sites | periodontal/peri-implant sites |
|
6 months for periodontitis group one month for peri-implantitis group, peri-implant health group and periodontal health group
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 - |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Mustafa YILMAZ | Biruni University | +90 533 7129952 | myilmaz@biruni.edu.tr |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 21, 2022 | Mar 21, 2022 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D057873 | Peri-Implantitis |
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Tissue samples
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 |
| BG002 | 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 + |
| BG003 | Peri-implantitis | Individuals with at least one implant site with radiographic bone loss, pocket depth ≥6mm and bleeding on probing + |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| 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 |
| OG002 | 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 + |
| OG003 | Peri-implantitis | Individuals with at least one implant site with radiographic bone loss, pocket depth ≥6mm and bleeding on probing + |
|
|
| 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. | Posted | Median | 95% Confidence Interval | arbitrary density units | Baseline | periodontal/peri-implant sites | periodontal/peri-implant sites |
|
|
|
| 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. | Posted | Median | 95% Confidence Interval | arbitrary density units | Baseline | periodontal/peri-implant sites | periodontal/peri-implant sites |
|
|
|
| Primary | CD80/CD163 Ratio | Tissue levels (Western Blot assay analyzed using Image J software) of CD80 divided by those of CD163 | Posted | Median | 95% Confidence Interval | ratio (no unit) | Baseline | periodontal/peri-implant sites | periodontal/peri-implant sites |
|
|
|
| Primary | CD80/CD206 Ratio | Tissue levels (Western Blot assay analyzed using Image J software) of CD80 divided by those of CD206 | Posted | Median | 95% Confidence Interval | ratio (no unit) | Baseline | periodontal/peri-implant sites | periodontal/peri-implant sites |
|
|
|
| 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. | The probing depth of sites with periodontal health, periodontitis and peri-implantitis were recorded individually. Probing depth of the peri-implant health group was not measured, since the sites forming the peri-implant health group have no probable peri-implant sulcus/pocket. | Posted | Mean | Standard Deviation | mm | Baseline | periodontal/peri-implant sites | periodontal/peri-implant sites |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | 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 | 0 | 8 | 0 | 8 | 0 | 8 |
| EG002 | 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 + | 0 | 9 | 0 | 9 | 0 | 9 |
| EG003 | Peri-implantitis | Individuals with at least one implant site with radiographic bone loss, pocket depth ≥6mm and bleeding on probing + | 0 | 9 | 0 | 9 | 0 | 9 |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| periodontal/peri-implant sites |
|
| periodontal/peri-implant sites |
|
| periodontal/peri-implant sites |
|
| periodontal/peri-implant sites |
|