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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04690621
Other study ID # GermanAOI2012
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2012
Est. completion date August 7, 2013

Study information

Verified date June 2012
Source German Association of Oral Implantology e. V.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Aim of the multi centrical, cross-sectional study is the registration of the prevalence and incidence of mucositis and periimplantitis.


Description:

Aim of the multi centrical, cross-sectional study is the registration of the prevalence and incidence of mucositis and periimplantitis. Additional clinical examination of the tolerance of titanium using cytosine analysis of periimplant sulcus smear and of blood lymphocytes on titanium plates in vitro. In total 10 centers will examine clinical, genetic and microbiological parameters in 200 patients during 12 months. Study hypothesis: The incidence of mucositis and periimplantitis during a time period of 10 years in patients is less than 30%


Recruitment information / eligibility

Status Completed
Enrollment 192
Est. completion date August 7, 2013
Est. primary completion date February 20, 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with oral implants inserted after 01.04.2002 - Periodical recall Exclusion Criteria: - No other titanium implants inside the body

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Germany Gerhard Iglhaut Memmingen

Sponsors (1)

Lead Sponsor Collaborator
German Association of Oral Implantology e. V.

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary IL-1ß Interleucin 1 beta in peripheral blood 6 month
Secondary MMP-8 Metallomatrixproteinase-8 in Periodontal Sulcus Fluid 6 month
Secondary BOP Bleeding on probing 6 months
Secondary PD Probing Depth 6 months
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