Observational Study on Implant Removal | NCT06234800

Studies
Observational Study on Implant Removal

NCT06234800

Sponsor

George Eastman Dental Hospital, Italy

Status

Completed

Last Update Posted

Jan 31, 2024Actual

Enrollment

381Actual

Phase

Not provided

Conditions

Implant Complication

Interventions

Removal of failed dental implants

Countries

Italy

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

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

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

Jan 4, 2003Actual

Primary Completion Date

Jan 10, 2024Actual

Completion Date

Jan 10, 2024Actual

First Submitted Date

Jan 20, 2024

First Submission Date that Met QC Criteria

Jan 30, 2024

First Posted Date

Jan 31, 2024Actual

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

Jan 30, 2024

Last Update Posted Date

Jan 31, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lucrezia Paternò Holtzman, Research assistant, George Eastman Dental Hospital, ItalyPrincipal Investigator

Lead Sponsor

George Eastman Dental Hospital, ItalyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

381Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Removal of failed dental implants	Procedure	Removal (with various techniques) of failed dental implants.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Implant survival	years	from 2000 to 2020

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all rehabilitated dental implants

Exclusion Criteria:

implants with complications that were treated and didn't require removal for complication management.
patients who could not undergo implant removal for reasons of general health

Accepts Healthy Volunteers

Not provided

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

All patients presenting to the department of Oral Surgery with failing or failed osteointegrated dental implants.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
George Eastman Dental Hospital		Roma		00100	Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Only means and standard deviations will be shared

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided