Peri-Implantitis, Periodontitis
Conditions
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.
Detailed 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.
Interventions
None listed
Sponsors
University of Turku
Biruni University
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CD80 | 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. |
| CD163 | 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. |
| CD206 | 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. |
| CD80/CD163 Ratio | Baseline | Tissue levels (Western Blot assay analyzed using Image J software) of CD80 divided by those of CD163 |
| CD80/CD206 Ratio | Baseline | Tissue levels (Western Blot assay analyzed using Image J software) of CD80 divided by those of CD206 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Probing Depth | Baseline | Probing depth of each site, where the tissue sample was harvested. The average probing depth of sites in each group are presented. |
Countries
Turkey (Türkiye)
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 - | 10 |
| 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 | 8 |
| 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 + | 9 |
| Peri-implantitis Individuals with at least one implant site with radiographic bone loss, pocket depth ≥6mm and bleeding on probing + | 9 |
| Total | 36 |
Baseline characteristics
| Characteristic | Peri-implant Health | Periodontitis | Peri-implantitis | Periodontal Health | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 9 Participants | 9 Participants | 10 Participants | 36 Participants |
| Age, Continuous | 44.4 years STANDARD_DEVIATION 11.4 | 43 years STANDARD_DEVIATION 18.8 | 48.7 years STANDARD_DEVIATION 10.3 | 44 years STANDARD_DEVIATION 11.7 | 45.06 years STANDARD_DEVIATION 12.8 |
| Race and Ethnicity Not Collected | — | — | — | — | 0 Participants |
| Region of Enrollment Turkey | 8 Participants | 9 Participants | 9 Participants | 10 Participants | 36 Participants |
| Sex: Female, Male Female | 3 Participants | 6 Participants | 6 Participants | 5 Participants | 20 Participants |
| Sex: Female, Male Male | 5 Participants | 3 Participants | 3 Participants | 5 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 8 | 0 / 9 | 0 / 9 |
| other Total, other adverse events | 0 / 10 | 0 / 8 | 0 / 9 | 0 / 9 |
| serious Total, serious adverse events | 0 / 10 | 0 / 8 | 0 / 9 | 0 / 9 |
Outcome results
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.
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Periodontal Health | CD163 | 24092.85 arbitrary density units |
| Peri-implant Health | CD163 | 36419.24 arbitrary density units |
| Periodontitis | CD163 | 2167.97 arbitrary density units |
| Peri-implantitis | CD163 | 6272.90 arbitrary density units |
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.
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Periodontal Health | CD206 | 17648.07 arbitrary density units |
| Peri-implant Health | CD206 | 15063.13 arbitrary density units |
| Periodontitis | CD206 | 4049.07 arbitrary density units |
| Peri-implantitis | CD206 | 16862.31 arbitrary density units |
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.
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Periodontal Health | CD80 | 7340.34 arbitrary density units |
| Peri-implant Health | CD80 | 10854.71 arbitrary density units |
| Periodontitis | CD80 | 6448.43 arbitrary density units |
| Peri-implantitis | CD80 | 9874.8 arbitrary density units |
Primary
CD80/CD163 Ratio
Tissue levels (Western Blot assay analyzed using Image J software) of CD80 divided by those of CD163
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Periodontal Health | CD80/CD163 Ratio | 0.417 ratio (no unit) |
| Peri-implant Health | CD80/CD163 Ratio | 0.413 ratio (no unit) |
| Periodontitis | CD80/CD163 Ratio | 3.075 ratio (no unit) |
| Peri-implantitis | CD80/CD163 Ratio | 0.801 ratio (no unit) |
Primary
CD80/CD206 Ratio
Tissue levels (Western Blot assay analyzed using Image J software) of CD80 divided by those of CD206
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Periodontal Health | CD80/CD206 Ratio | 0.376 ratio (no unit) |
| Peri-implant Health | CD80/CD206 Ratio | 0.525 ratio (no unit) |
| Periodontitis | CD80/CD206 Ratio | 1.366 ratio (no unit) |
| Peri-implantitis | CD80/CD206 Ratio | 0.405 ratio (no unit) |
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.
Time frame: Baseline
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Periodontal Health | Probing Depth | 1.5 mm | Standard Deviation 0.71 |
| Peri-implant Health | Probing Depth | 7.78 mm | Standard Deviation 0.83 |
| Periodontitis | Probing Depth | 7.78 mm | Standard Deviation 1.09 |