Trial Outcomes & Findings for Macrophage Markers in Periodontal and Peri-implant Health and Disease (NCT NCT05242354)
NCT ID: NCT05242354
Last Updated: 2023-05-18
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
36 participants
Primary outcome timeframe
Baseline
Results posted on
2023-05-18
Participant Flow
Participant milestones
| Measure |
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 +
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
8
|
9
|
9
|
|
Overall Study
COMPLETED
|
10
|
8
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Periodontal Health
n=10 Participants
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
n=8 Participants
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
n=9 Participants
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
n=9 Participants
Individuals with at least one implant site with radiographic bone loss, pocket depth ≥6mm and bleeding on probing +
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=10 Participants
|
8 Participants
n=8 Participants
|
9 Participants
n=9 Participants
|
9 Participants
n=9 Participants
|
36 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=36 Participants
|
|
Age, Continuous
|
44 years
STANDARD_DEVIATION 11.7 • n=10 Participants
|
44.4 years
STANDARD_DEVIATION 11.4 • n=8 Participants
|
43 years
STANDARD_DEVIATION 18.8 • n=9 Participants
|
48.7 years
STANDARD_DEVIATION 10.3 • n=9 Participants
|
45.06 years
STANDARD_DEVIATION 12.8 • n=36 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=10 Participants
|
3 Participants
n=8 Participants
|
6 Participants
n=9 Participants
|
6 Participants
n=9 Participants
|
20 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=10 Participants
|
5 Participants
n=8 Participants
|
3 Participants
n=9 Participants
|
3 Participants
n=9 Participants
|
16 Participants
n=36 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Turkey
|
10 Participants
n=10 Participants
|
8 Participants
n=8 Participants
|
9 Participants
n=9 Participants
|
9 Participants
n=9 Participants
|
36 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: BaselineTissue 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.
Outcome measures
| Measure |
Periodontal Health
n=10 periodontal/peri-implant sites
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
n=8 periodontal/peri-implant sites
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
n=9 periodontal/peri-implant sites
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
n=9 periodontal/peri-implant sites
Individuals with at least one implant site with radiographic bone loss, pocket depth ≥6mm and bleeding on probing +
|
|---|---|---|---|---|
|
CD80
|
7340.34 arbitrary density units
Interval 3259.33 to 22949.08
|
10854.71 arbitrary density units
Interval 6212.94 to 15352.85
|
6448.43 arbitrary density units
Interval 4040.25 to 11881.73
|
9874.8 arbitrary density units
Interval 5498.12 to 13903.64
|
PRIMARY outcome
Timeframe: BaselineTissue 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.
Outcome measures
| Measure |
Periodontal Health
n=10 periodontal/peri-implant sites
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
n=8 periodontal/peri-implant sites
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
n=9 periodontal/peri-implant sites
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
n=9 periodontal/peri-implant sites
Individuals with at least one implant site with radiographic bone loss, pocket depth ≥6mm and bleeding on probing +
|
|---|---|---|---|---|
|
CD163
|
24092.85 arbitrary density units
Interval 14131.26 to 39359.0
|
36419.24 arbitrary density units
Interval 16424.64 to 40646.48
|
2167.97 arbitrary density units
Interval -2847.23 to 14877.2
|
6272.90 arbitrary density units
Interval 1722.4 to 26614.33
|
PRIMARY outcome
Timeframe: BaselineTissue 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.
Outcome measures
| Measure |
Periodontal Health
n=10 periodontal/peri-implant sites
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
n=8 periodontal/peri-implant sites
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
n=9 periodontal/peri-implant sites
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
n=9 periodontal/peri-implant sites
Individuals with at least one implant site with radiographic bone loss, pocket depth ≥6mm and bleeding on probing +
|
|---|---|---|---|---|
|
CD206
|
17648.07 arbitrary density units
Interval 8965.15 to 25836.34
|
15063.13 arbitrary density units
Interval 5505.74 to 37182.25
|
4049.07 arbitrary density units
Interval 553.59 to 14523.94
|
16862.31 arbitrary density units
Interval 8629.42 to 36697.95
|
PRIMARY outcome
Timeframe: BaselineTissue levels (Western Blot assay analyzed using Image J software) of CD80 divided by those of CD163
Outcome measures
| Measure |
Periodontal Health
n=10 periodontal/peri-implant sites
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
n=8 periodontal/peri-implant sites
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
n=9 periodontal/peri-implant sites
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
n=9 periodontal/peri-implant sites
Individuals with at least one implant site with radiographic bone loss, pocket depth ≥6mm and bleeding on probing +
|
|---|---|---|---|---|
|
CD80/CD163 Ratio
|
0.417 ratio (no unit)
Interval 0.139 to 0.902
|
0.413 ratio (no unit)
Interval 0.286 to 0.485
|
3.075 ratio (no unit)
Interval 1.338 to 5.135
|
0.801 ratio (no unit)
Interval -0.792 to 8.762
|
PRIMARY outcome
Timeframe: BaselineTissue levels (Western Blot assay analyzed using Image J software) of CD80 divided by those of CD206
Outcome measures
| Measure |
Periodontal Health
n=10 periodontal/peri-implant sites
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
n=8 periodontal/peri-implant sites
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
n=9 periodontal/peri-implant sites
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
n=9 periodontal/peri-implant sites
Individuals with at least one implant site with radiographic bone loss, pocket depth ≥6mm and bleeding on probing +
|
|---|---|---|---|---|
|
CD80/CD206 Ratio
|
0.376 ratio (no unit)
Interval -0.712 to 1.743
|
0.525 ratio (no unit)
Interval 0.283 to 1.232
|
1.366 ratio (no unit)
Interval 0.62 to 2.132
|
0.405 ratio (no unit)
Interval -1.205 to 5.153
|
SECONDARY outcome
Timeframe: BaselinePopulation: 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.
Probing depth of each site, where the tissue sample was harvested. The average probing depth of sites in each group are presented.
Outcome measures
| Measure |
Periodontal Health
n=10 periodontal/peri-implant sites
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
n=9 periodontal/peri-implant sites
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
n=9 periodontal/peri-implant sites
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 +
|
|---|---|---|---|---|
|
Probing Depth
|
1.5 mm
Standard Deviation 0.71
|
7.78 mm
Standard Deviation 0.83
|
7.78 mm
Standard Deviation 1.09
|
—
|
Adverse Events
Periodontal Health
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Peri-implant Health
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Periodontitis
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Peri-implantitis
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place