Peri-ImplantitisNCT05242354
Macrophage Markers in Periodontal and Peri-implant Health and Disease
An observational study of Peri-Implantitis and Periodontitis, run by Biruni University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peri-Implantitis, Periodontitis
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2021to 31 Dec 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Otherwise healthy periodontitis, peri-implantitis patients or periodontally healthy individuals who applied to Biruni University Dentistry Faculty for treatment / regular oral examination
Who may be able to join
- 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
Who cannot join
- systemic disease
- smoking / former smokers
- regular medicine intake
- antibiotic or anti-inflammatory medicine intake in the last 3 months
- pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CD80, CD163 and CD206 Tissue Levels in Periodontal and Peri-implant Health and Disease
Macrophage surface markers (CD80, CD163 and CD206) will be evaluated in periodontally healthy gingiva, healthy peri-implant mucosa, and periodontitis and peri-implantitis lesions.
Read the 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.
- Conditions
- Peri-Implantitis, Periodontitis
- Medical subject headings
- Peri-Implantitis, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 + |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline
CD80/CD163 Ratio
Tissue levels (Western Blot assay analyzed using Image J software) of CD80 divided by those of CD163
Measured: Baseline
CD80/CD206 Ratio
Tissue levels (Western Blot assay analyzed using Image J software) of CD80 divided by those of CD206
Measured: Baseline
Secondary outcomes (1)
Probing Depth
Probing depth of each site, where the tissue sample was harvested. The average probing depth of sites in each group are presented.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start1 Mar 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peri-ImplantitisStudies of the same condition, open and under way.
- More trials run by Biruni UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Turku
- Responsible party
- Principal investigator, Mustafa YILMAZ, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05242354
- Sponsor's protocol ID
- Peri-implant macrophage
- Status last verified
- May 2023
- First submitted
- 28 Jan 2022
- Last updated
- 18 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators plan to share the data with other researchers who demand it.
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CD80, CD163 and CD206 Tissue Levels in Periodontal and Peri-implant Health and Disease
- ClinicalTrials.gov ID
- NCT05242354
- Acronym / sponsor ID
- Peri-implant macrophage
- Conditions
- Peri-Implantitis, Periodontitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Collaborators
- University of Turku
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 16 Feb 2022 (actual)
- Results
- Posted 18 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 + |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Otherwise healthy periodontitis, peri-implantitis patients or periodontally healthy individuals who applied to Biruni University Dentistry Faculty for treatment / regular oral examination
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- systemic disease
- smoking / former smokers
- regular medicine intake
- antibiotic or anti-inflammatory medicine intake in the last 3 months
- pregnancy or lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
CD80
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline
Tissue levels (Western Blot assay analyzed using Image J software) of CD80 divided by those of CD163
CD80/CD206 Ratio
Time frame: Baseline
Tissue levels (Western Blot assay analyzed using Image J software) of CD80 divided by those of CD206
1 secondary outcome
Probing Depth
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. The investigators plan to share the data with other researchers who demand it.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peri-Implantitis and Periodontitis, run by Biruni University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CD80 (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2023.