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Pilot study to determine calprotectin and aMMP-8 concentrations in sulcus fluid in patients >= 65 years of age.

Pilot study to determine calprotectin and aMMP-8 concentrations in sulcus fluid in patients >= 65 years of age.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00027385
Enrollment
30
Registered
2022-04-08
Start date
2022-04-15
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

K05.1 K05.3

Interventions

Group 1: Patients with clinically diagnosed gingivitis Group 2: Patients with clinically diagnosed periodontitis Group 3: Patients with clinically healthy periodontium

Sponsors

Poliklinik für Zahnerhaltung und Parodontologie, Zentrum für Zahn- Mund und Kieferheilkunde, Uniklinik Köln
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 100 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria are age >= 65 years and written informed consent, in treatment at the Polyclinic of Dental Preservation and Periodontology.

Exclusion criteria

Exclusion criteria: Exclusion criteria are active tumor disease requiring treatment, infection requiring treatment, current antibiotic treatment, chronic inflammatory disease such as rheumatoid arthritis, inflammatory bowel disease, osteomyelitis, or previous (within 2 weeks) apoplectic insult with lysis treatment; GFR <30 ml / min, dialysis requirement, coronary artery disease requiring intervention, non-plaque induced gingivitis. These diseases lead to altered sulclus fluid levels of calprotectin and aMMP-8 in the presence of high inflammatory markers and should therefore be excluded from inclusion.

Design outcomes

Primary

MeasureTime frame
During the clinical implementation of the study protocol (DRKS ID: DRKS00024446), which has already received a positive decision, it was noticed in the study population included there (geriatric patients) that the resulting aMMP-8 and calprotectin values were significantly outside the expected reference values. After consultation with the laboratory, the question arose whether this is a) due to the fact that the study protocol cannot be optimally performed in outreach care or b) the reference values are not applicable for this population. Therefore, the pilot study presented here will first clarify whether the test procedure depicts valid results for patients of the same age with the corresponding gum diseases in order to then be able to further conduct study 20-1721 or to put its results into a concrete overall context. Study parameters: - Age and gender - Clinical oral findings in the context of heal care - Calprotectin and aMMP-8 concentrations of the sulcus fluid

Secondary

MeasureTime frame
The aim of this pilot study is to investigate calprotectin and aMMP8 levels in the sulcular fluid of patients with clinically diagnosed gingivitis and periodontitis. These levels will be compared to those of patients with gingival and periodontal health.

Countries

Germany

Contacts

Public ContactAlicia Blasi

Poliklinik für Zahnerhaltung und Parodontologie, Zentrum für Zahn- Mund und Kieferheilkunde, Uniklinik Köln

alicia.blasi@uk-koeln.de+49 221 478-7174

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026