Jaw, Edentulous, PartiallyNCT03252106
Long-term Effectiveness of Contour Augmentation in Sites With Early Implant Placement
A study testing Contour augmentation with implant placement in people with Jaw, Edentulous, Partially and Dental Implants, Single-tooth, run by University of Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Jaw, Edentulous, Partially, Dental Implants, Single-tooth, Grafting Bone
- What is being tested?
- Contour augmentation with implant placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 10 Oct 2016to 10 Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Single tooth gaps post extraction in the esthetic zone
- Written informed consent
Who cannot join
- Heavy smoking (more than 10 cigarettes per day)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Contour augmentation with implant placement
- Medical subject headings
- Jaw, Edentulous, Partially
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contour augmentation with implant placementProcedure or surgery
Contour augmentation with implant placement
| Study group | Role | What they receive |
|---|---|---|
| Contour augmentation | Experimental | Not described Receives: Procedure: Contour augmentation with implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of contour augmentation
Measurement of facial bone wall width with cone beam CTs (in mm)
Measured: 10 year examination
Secondary outcomes (4)
Esthetic examination
Pink Esthetic Score
Measured: 10 year examination
Peri-Implant soft tissue health
Plaque Index
Measured: 10 year examination
Peri-implant bone loss over time
Distance from the implant-shoulder to the first bone-to-implant-contact (DIB) in mm
Measured: 10 year examination
Peri-Implant soft tissue health
Sulcus Bleeding Index
Measured: 10 year examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2017
- Study start10 Oct 2016
- Primary completion10 Nov 2016
- Study completion10 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Jaw, Edentulous, PartiallyStudies of the same condition, open and under way.
- More trials run by University of BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Buser, DMD, Study chair, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03252106
- Sponsor's protocol ID
- P004 Study
- Status last verified
- Aug 2017
- First submitted
- 19 Jul 2017
- Last updated
- 17 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Effectiveness of Contour Augmentation in Sites With Early Implant Placement
- ClinicalTrials.gov ID
- NCT03252106
- Acronym / sponsor ID
- P004 Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Study start
- 10 Oct 2016 (actual)
- Primary completion
- 10 Nov 2016 (actual)
- Study completion
- 10 Nov 2016 (actual)
- First posted
- 17 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Contour augmentation | Experimental | Procedure: Contour augmentation with implant placement |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Single tooth gaps post extraction in the esthetic zone
- Written informed consent
Key exclusion criteria (1 listed)
- Heavy smoking (more than 10 cigarettes per day)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contour augmentation with implant placementContour augmentation with implant placement | Procedure or surgery | Contour augmentation |
Primary outcome
Effectiveness of contour augmentation
Time frame: 10 year examination
Measurement of facial bone wall width with cone beam CTs (in mm)
4 secondary outcomes
Esthetic examination
Time frame: 10 year examination
Peri-Implant soft tissue health
Time frame: 10 year examination
Peri-implant bone loss over time
Time frame: 10 year examination
Peri-Implant soft tissue health
Time frame: 10 year examination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2017.
- Derived from this study: PubMed 29073362Chappuis 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.
Related trials for Jaw, Edentulous, Partially
Active, not recruiting
L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
Not yet recruitingObservational study
Digital and Conventional Clasp-retained Partial Dentures (DIGICLASP)
Partial Edentulism
Active, not recruiting
Multicenter Study to Evaluate the Clinical Outcome of PrimeTaper EV Implant in Single Tooth Restorations
Jaw, Edentulous, Partially
Recruiting
Clinical and Radiographic Evaluation of UV-Treated Dental Implants With or Without Melatonin in the Upper Posterior Jaw
Jaw, Edentulous, Partially, Bone Resorption
Active, not recruiting
A Clinical Study on Acuris™ - Conometric Concept for Single Tooth Restoration
Jaw, Edentulous, Partially
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Buser, DMD study chair
University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contour augmentation with implant placement in people with Jaw, Edentulous, Partially and Dental Implants, Single-tooth, run by University of Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of contour augmentation (time frame: 10 year examination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03252106, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2017.