Long-term Effectiveness of Contour Augmentation in Sites... | NCT03252106

Studies
Long-term Effectiveness of Contour Augmentation in Sites With Early Implant Placement

NCT03252106

Sponsor

University of Bern

Status

Completed

Last Update Posted

Aug 17, 2017Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Jaw, Edentulous, Partially
Dental Implants, Single-tooth
Grafting Bone

Interventions

Contour augmentation with implant placement

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

Aug 2017

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 10, 2016Actual

Primary Completion Date

Nov 10, 2016Actual

Completion Date

Nov 10, 2016Actual

First Submitted Date

Jul 19, 2017

First Submission Date that Met QC Criteria

Aug 14, 2017

First Posted Date

Aug 17, 2017Actual

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

Aug 14, 2017

Last Update Posted Date

Aug 17, 2017Actual

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

In this prospective case series study, 20 patients with an implant-borne single crown following early implant placement with simultaneous contour augmentation will be followed for 10 years. Clinical, radiologic, and esthetic parameters will be assessed. In addition, cone beam computed tomography (CBCT) will be used at 10 years to examine the facial bone wall and compared to the 6 year data.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Contour augmentation	Experimental		Procedure: Contour augmentation with implant placement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Contour augmentation with implant placement	Procedure	Contour augmentation with implant placement	Contour augmentation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Effectiveness of contour augmentation	Measurement of facial bone wall width with cone beam CTs (in mm)	10 year examination

Secondary Outcomes

Measure	Description	Time Frame
Esthetic examination	Pink Esthetic Score	10 year examination
Peri-Implant soft tissue health	Plaque Index	10 year examination

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Single tooth gaps post extraction in the esthetic zone
Written informed consent

Exclusion Criteria:

Heavy smoking (more than 10 cigarettes per day)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Daniel Buser, DMD	University of Bern	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Inselspital		Bern		3010	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29073362	Derived	Chappuis V, Rahman L, Buser R, Janner SFM, Belser UC, Buser D. Effectiveness of Contour Augmentation with Guided Bone Regeneration: 10-Year Results. J Dent Res. 2018 Mar;97(3):266-274. doi: 10.1177/0022034517737755. Epub 2017 Oct 26.

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