PeriimplantitisPeriX2012NCT04690621
Cross-sectional Examination of the Reliability of Oral Implants
An observational study of Periimplantitis, run by German Association of Oral Implantology e. V. at 1 site in Germany.
Trial summary
Aim of the multi centrical, cross-sectional study is the registration of the prevalence and incidence of mucositis and periimplantitis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periimplantitis
- How many people
- 192 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2012to 7 Aug 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients with oral implants inserted after 01.04.2002
Who may be able to join
- Patients with oral implants inserted after 01.04.2002
- Periodical recall
Who cannot join
- No other titanium implants inside the body
Trial locations and contacts
1 site in 1 country.
About this study
Aim of the multi centrical, cross-sectional study is the registration of the prevalence and incidence of mucositis and periimplantitis.
Read the 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%
- Conditions
- Periimplantitis
- Keywords
- peri-implant disease prevalence incidence tolerance titanium
- Medical subject headings
- Peri-Implantitis
What is being measured
The primary outcome is the main question the study is designed to answer.
IL-1ß
Interleucin 1 beta in peripheral blood
Measured: 6 month
Secondary outcomes (3)
MMP-8
Metallomatrixproteinase-8 in Periodontal Sulcus Fluid
Measured: 6 month
BOP
Bleeding on probing
Measured: 6 months
PD
Probing Depth
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start1 Jul 2012
- Primary completion20 Feb 2013
- Study completion7 Aug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriimplantitisStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- German Association of Oral Implantology e. V.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gerhard Iglhaut, DDS, PhD, Principal investigator, Academy Member
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04690621
- Sponsor's protocol ID
- GermanAOI2012
- Acronym
- PeriX2012
- Status last verified
- Jun 2012
- First submitted
- 20 Dec 2020
- Last updated
- 30 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-sectional Examination of the Reliability of Oral Implants
- ClinicalTrials.gov ID
- NCT04690621
- Acronym / sponsor ID
- PeriX2012 / GermanAOI2012
- Conditions
- Periimplantitis
- Keywords
- peri-implant disease prevalence incidence tolerance titanium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- German Association of Oral Implantology e. V.University, hospital or other
- Study start
- 1 Jul 2012 (actual)
- Primary completion
- 20 Feb 2013 (actual)
- Study completion
- 7 Aug 2013 (actual)
- First posted
- 30 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim of the multi centrical, cross-sectional study is the registration of the prevalence and incidence of mucositis and periimplantitis.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with oral implants inserted after 01.04.2002
Key inclusion criteria (2 listed)
- Patients with oral implants inserted after 01.04.2002
- Periodical recall
Key exclusion criteria (1 listed)
- No other titanium implants inside the body
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
IL-1ß
Time frame: 6 month
Interleucin 1 beta in peripheral blood
3 secondary outcomes
MMP-8
Time frame: 6 month
BOP
Time frame: 6 months
PD
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2020.
- German Association of Oral ImplantologyLink provided by the sponsor.
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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.
Gerhard Iglhaut, DDS, PhD principal investigator
Academy Member
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 Periimplantitis, run by German Association of Oral Implantology e. V. at 1 site in Germany.
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 2 inclusion and 1 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 30 Dec 2020. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
IL-1ß (time frame: 6 month). 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 30 Dec 2020.