Early and Late Implant Failure | NCT04270396

Studies
Early and Late Implant Failure

NCT04270396

Sponsor

Universitat Internacional de Catalunya

Status

Completed

Last Update Posted

Feb 17, 2020Actual

Enrollment

190Actual

Phase

Not provided

Conditions

Dental Implant Failed
Peri-Implantitis

Interventions

Presence or absence of implant

Countries

Spain

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

Feb 2020

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

Oct 5, 2017Actual

Primary Completion Date

Mar 14, 2019Actual

Completion Date

Apr 24, 2019Actual

First Submitted Date

Feb 12, 2020

First Submission Date that Met QC Criteria

Feb 12, 2020

First Posted Date

Feb 17, 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

Feb 12, 2020

Last Update Posted Date

Feb 17, 2020Actual

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

Description Module

Brief Summary

The aim of this study was to evaluate the early and late implant loss rate in a sample of patients who had received implant-supportive restorative therapy in a university setting. Moreover, the study aimed to identify patient- and implant-related variables for implant failure

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

190Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Presence or absence of implant	Behavioral	We procedure to observed clinically the sample size, to be able to determine if the dental implant was present or no. If the implant was absent we recorded if it was early( prior to restoration) or late ( after prosthesis was delivered).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Implant survival	Early implant loss and late implant loss	October 2017 to March 2019

Secondary Outcomes

Measure	Description	Time Frame
Implant failure	biological and mechanical complications	October 2017 to March 2019

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Men and women over 18 years old
Partially or totally edentulous patients with at least one implant placed at the university and at least 7 years before.
Cemented, screwed, or mechanically retained prosthesis.
Single and partial prostheses, as well as complete arch prosthesis (fixed and removable).

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

A sample of men and women over 18 years old, which they had received an implant-supportive restorative therapy in a university setting throughout a period of at least 7 years.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joan Takamoli	Universitat Internacional de Catalunya	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Joan		Barcelona		08025	Spain

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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