Cross-sectional Examination of the Reliability of Oral Implants (PeriX2012)

December 29, 2020 updated by: German Association of Oral Implantology e. V.
Aim of the multi centrical, cross-sectional study is the registration of the prevalence and incidence of mucositis and periimplantitis.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

192

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Memmingen, Germany, 87700
        • Gerhard Iglhaut

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with oral implants inserted after 01.04.2002

Description

Inclusion Criteria:

  • Patients with oral implants inserted after 01.04.2002
  • Periodical recall

Exclusion Criteria:

  • No other titanium implants inside the body

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IL-1ß
Time Frame: 6 month
Interleucin 1 beta in peripheral blood
6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MMP-8
Time Frame: 6 month
Metallomatrixproteinase-8 in Periodontal Sulcus Fluid
6 month
BOP
Time Frame: 6 months
Bleeding on probing
6 months
PD
Time Frame: 6 months
Probing Depth
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

German Association of Oral Implantology e. V.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2012

Primary Completion (Actual)

February 20, 2013

Study Completion (Actual)

August 7, 2013

Study Registration Dates

First Submitted

December 20, 2020

First Submitted That Met QC Criteria

December 29, 2020

First Posted (Actual)

December 30, 2020

Study Record Updates

Last Update Posted (Actual)

December 30, 2020

Last Update Submitted That Met QC Criteria

December 29, 2020

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GermanAOI2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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