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CompletedNCT03252106Updated Aug 17, 2017

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

An interventional study of Contour augmentation with implant placement in Jaw, Edentulous, Partially, Dental Implants, Single-tooth and Grafting Bone, sponsored by University of Bern. Completed at 1 site in Switzerland. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-17.

Sponsored by University of Bern · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Oct 2016, registered Jul 2017).

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Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
20 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Jaw, Edentulous, Partially
  • Dental Implants, Single-tooth
  • Grafting Bone
03

In context

Jaw, Edentulous, Partially

76 studies on the registry are indexed under Jaw, Edentulous, Partially; 7 are open to participants now.

This study's enrollment of 20 is below the median of 38 across 67 interventional studies indexed under Jaw, Edentulous, Partially.

Browse Jaw, Edentulous, Partially studies →

Lead sponsor

University of Bern is the lead sponsor of 209 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Heavy smoking (more than 10 cigarettes per day)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Contour augmentation

    Procedure: Contour augmentation with implant placement

Interventions

  • ProcedureContour augmentation with implant placement

    Contour augmentation with implant placement

06

What researchers measure

Primary outcomes

  1. Effectiveness of contour augmentation

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

    Time frame: 10 year examination

Secondary outcomes

  1. Esthetic examination

    Pink Esthetic Score

    Time frame: 10 year examination

  2. Peri-Implant soft tissue health

    Plaque Index

    Time frame: 10 year examination

  3. Peri-implant bone loss over time

    Distance from the implant-shoulder to the first bone-to-implant-contact (DIB) in mm

    Time frame: 10 year examination

  4. Peri-Implant soft tissue health

    Sulcus Bleeding Index

    Time frame: 10 year examination

07

Study locations

1 site
  • University Hospital Inselspital
    Bern, 3010, Switzerland
08

References and documents

Publications

  • 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. PubMed 29073362 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2016 to primary completion in Nov 2016, 1 month.

Of 34 interventional studies with no phase under Jaw, Edentulous, Partially, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 61. This study's 1 month is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 19, 2017
First posted
Aug 17, 2017
StartActual
Oct 10, 2016
Primary completionActual
Nov 10, 2016
CompletionActual
Nov 10, 2016
Last update
Aug 17, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 17, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03252106
Lead sponsor
University of Bern
Responsible party
Sponsor
First posted
Aug 17, 2017
Start date
Oct 10, 2016
Primary completion
Nov 10, 2016
Completion
Nov 10, 2016
Last update
Aug 17, 2017

Study contacts

Daniel Buser, DMD
study chair · University of Bern

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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