Survival and Success Rates of 6mm Implants With a Micro-r... | NCT04017026

Studies
Survival and Success Rates of 6mm Implants With a Micro-rough Surface After 4.5 - 18.2 Years in Function

NCT04017026

Sponsor

University of Bern

Status

Completed

Last Update Posted

Sep 3, 2020Actual

Enrollment

74Actual

Phase

Not provided

Conditions

Jaw, Edentulous, Partially
Dental Implant Failed
Implant Complication

Interventions

Implantation

Countries

Switzerland

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

Sep 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

May 9, 2018Actual

Primary Completion Date

Apr 8, 2019Actual

Completion Date

Jun 30, 2020Actual

First Submitted Date

Apr 3, 2019

First Submission Date that Met QC Criteria

Jul 9, 2019

First Posted Date

Jul 12, 2019Actual

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

Sep 2, 2020

Last Update Posted Date

Sep 3, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In this retrospective study, approximately 60 patients treated with 6mm short implants (Straumann, SLA (sandblasted, large-grit, acid-etched surface), SLActive (sandblasted, large-grit, acid-etched, hydrophilic surface), 4.1 or 4.8 mm in diameter) will be followed for 4.5-18.2 years. Clinical and radiographic parameters will be assessed in a follow-up examination.

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

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

74Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
6 mm implants		Patients were treated with 6mm short implants (Straumann, SLA, SLActive, 4.1 or 4.8 mm in diameter).	Device: Implantation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Implantation	Device	Implantation of 6 mm short implants	6 mm implants

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Implant survival rates	Survival rates of short dental implants	5-18 years

Secondary Outcomes

Measure	Description	Time Frame
Radiographic: Annual bone loss	Distance from the implant shoulder to the marginal bone.	5-18 years
Clinically: modifying risk factors on implant survival and success	Plaque-index

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Partially or fully edentulous jaw
Written informed consent

Exclusion Criteria:

Pregnant women/lactating women

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

All patients treated with a 6mm short implant at the University of Bern were recalled for a clinical and radiographic follow-up examination.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vivianne Chappuis, DMD	University of Bern	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department for oral surgery of the zmk Bern, University of Bern		Bern		3010	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D007576	Jaw, Edentulous, Partially

Ancestor Terms

ID	Term
D007575	Jaw, Edentulous
D007571	Jaw Diseases
D009140	Musculoskeletal Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided