Cross-sectional Examination of the Reliability of Oral Im... | NCT04690621

Studies
Cross-sectional Examination of the Reliability of Oral Implants

NCT04690621

Sponsor

German Association of Oral Implantology e. V.

Status

Completed

Last Update Posted

Dec 30, 2020Actual

Enrollment

192Actual

Phase

Not provided

Conditions

Periimplantitis

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2012Actual

Primary Completion Date

Feb 20, 2013Actual

Completion Date

Aug 7, 2013Actual

First Submitted Date

Dec 20, 2020

First Submission Date that Met QC Criteria

Dec 29, 2020

First Posted Date

Dec 30, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 29, 2020

Last Update Posted Date

Dec 30, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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%

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

192Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
MMP-8	Metallomatrixproteinase-8 in Periodontal Sulcus Fluid	6 month
BOP	Bleeding on probing	6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with oral implants inserted after 01.04.2002
Periodical recall

Exclusion Criteria:

No other titanium implants inside the body

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with oral implants inserted after 01.04.2002

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gerhard Iglhaut, DDS, PhD	Academy Member	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gerhard Iglhaut		Memmingen		87700	Germany

Label	URL
German Association of Oral Implantology	View source

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Dec 14, 2011	Dec 26, 2020	Prot_000.pdf
ICF	No	No	Yes	Informed Consent Form	Dec 23, 2011	Dec 26, 2020	ICF_001.pdf

Condition Browse Module

MeSH Terms

ID	Term
D057873	Peri-Implantitis

Ancestor Terms

ID	Term
D010510	Periodontal Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided