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PeriX2012: Cross-sectional Examination of the Reliability of Oral Implants

Sponsor
German Association of Oral Implantology e. V. (Other)
Overall Status
Completed
CT.gov ID
NCT04690621
Collaborator
(none)
192
Enrollment
1
Location
13.2
Actual Duration (Months)
14.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Detailed 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%

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    192 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Cross-sectional Examination of the Reliability of Oral Implants
    Actual Study Start Date :
    Jul 1, 2012
    Actual Primary Completion Date :
    Feb 20, 2013
    Actual Study Completion Date :
    Aug 7, 2013

    Outcome Measures

    Primary Outcome Measures

    1. IL-1ß [6 month]

      Interleucin 1 beta in peripheral blood

    Secondary Outcome Measures

    1. MMP-8 [6 month]

      Metallomatrixproteinase-8 in Periodontal Sulcus Fluid

    2. BOP [6 months]

      Bleeding on probing

    3. PD [6 months]

      Probing Depth

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Patients with oral implants inserted after 01.04.2002

    • Periodical recall

    Exclusion Criteria:
    • No other titanium implants inside the body

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Gerhard Iglhaut Memmingen Germany 87700

    Sponsors and Collaborators

    • German Association of Oral Implantology e. V.

    Investigators

    • Principal Investigator: Gerhard Iglhaut, DDS, PhD, Academy Member

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    German Association of Oral Implantology e. V.
    ClinicalTrials.gov Identifier:
    NCT04690621
    Other Study ID Numbers:
    • GermanAOI2012
    First Posted:
    Dec 30, 2020
    Last Update Posted:
    Dec 30, 2020
    Last Verified:
    Jun 1, 2012
    Keywords provided by German Association of Oral Implantology e. V.
    peri-implant disease prevalence incidence tolerance titanium
    Additional relevant MeSH terms:
    Peri-Implantitis

    Study Results

    No Results Posted as of Dec 30, 2020