NCT03252106

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2017

Completed
29 days until next milestone

First Posted

Study publicly available on registry

August 17, 2017

Completed
Last Updated

August 17, 2017

Status Verified

August 1, 2017

Enrollment Period

1 month

First QC Date

July 19, 2017

Last Update Submit

August 14, 2017

Conditions

Jaw, Edentulous, PartiallyDental Implants, Single-toothGrafting Bone

Outcome Measures

Primary Outcomes (1)

  • Effectiveness of contour augmentation

    Measurement of facial bone wall width with cone beam CTs (in mm)

    10 year examination

Secondary Outcomes (4)

  • Esthetic examination

    10 year examination

  • Peri-Implant soft tissue health

    10 year examination

  • Peri-implant bone loss over time

    10 year examination

  • Peri-Implant soft tissue health

    10 year examination

Study Arms (1)

Contour augmentation

EXPERIMENTAL
Procedure: Contour augmentation with implant placement

Interventions

Contour augmentation with implant placementPROCEDURE

Contour augmentation with implant placement

Contour augmentation

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Heavy smoking (more than 10 cigarettes per day)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Inselspital

Bern, 3010, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 29073362DERIVED

MeSH Terms

Conditions

Jaw, Edentulous, Partially

Condition Hierarchy (Ancestors)

Jaw, EdentulousJaw DiseasesMusculoskeletal DiseasesStomatognathic DiseasesMouth, EdentulousMouth DiseasesTooth Diseases

Study Officials

  • Daniel Buser, DMD

    University of Bern

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2017

First Posted

August 17, 2017

Study Start

October 10, 2016

Primary Completion

November 10, 2016

Study Completion

November 10, 2016

Last Updated

August 17, 2017

Record last verified: 2017-08

Locations

CH(1)