A 39-year Follow-up Study on the World´s First Single Den... | NCT06623968

Studies
A 39-year Follow-up Study on the World´s First Single Dental Implants

NCT06623968

Sponsor

Branemarkkliniken

Status

Completed

Last Update Posted

Oct 3, 2024Actual

Enrollment

23Actual

Phase

Not provided

Conditions

Edentulism

Interventions

Dental implants

Countries

Not provided

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

Oct 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

Dec 1, 1982Actual

Primary Completion Date

Dec 31, 1985Actual

Completion Date

Jun 30, 2024Actual

First Submitted Date

Sep 24, 2024

First Submission Date that Met QC Criteria

Sep 30, 2024

First Posted Date

Oct 2, 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

Oct 2, 2024

Last Update Posted Date

Oct 3, 2024Actual

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

This is a comprehensive, long-term follow-up study of single-implant treatments. At the Brånemark Clinic in Gothenburg, Sweden, during the period of 1982-1985, 16 patients received single-tooth implants. This study evaluates the survival rate of the implants after nearly four decades, focusing on the biological and technical complications.

Of the original 16 patients with a total of 23 implants, 14 patients with 19 implants were available for the follow-up and were included in the study. Clinical and radiographic examinations were performed on these patients.

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

39 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

23Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dental implants	Procedure	Long-term follow-up study on singel-tooth implants

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Biological and technical complications	Long-term follow-up of singel-tooth implants with regard to biological and/or technical complications	From enrollment in 1982 - today
Marginal bone level	Marginal bone level changes in mm	from 1982 to today

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient with diagnosis singel-tooth gap Patient with singel-tooth implants

Exclusion Criteria:

patient with bridge constructions

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All living patient included in the original prospective study

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015921	Dental Implants

Ancestor Terms

ID	Term
D003764	Dental Materials
D001697	Biomedical and Dental Materials
D017266	Dental Prosthesis
D011476	Prosthodontics

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Browse Branches

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