Jaw, Edentulous, PartiallyNCT00906425
Clinical Study Comparing Submerged Versus Trans-mucosal Healing of P.004 Implants in the Anterior Mandible and Maxilla
A study testing Straumann Bone Level Implant in people with Jaw, Edentulous, Partially, run by Institut Straumann AG at 11 sites in 7 countries.
Trial summary
The purpose of this study is To demonstrate that there is no difference in change in bone level around P.004 implants between 1st stage surgery and 6 months post surgery when transmucosal implant placement is compared to submerged implant placement Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Jaw, Edentulous, Partially
- What is being tested?
- Straumann Bone Level Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 11 sitesin 7 countries
- Study dates
- Oct 2006to Oct 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females >18 years of age.
- Implant placement planned in the anterior maxilla or mandible (FDI tooth numbers 21 - 25, 11 - 15, 31-35, 41-45).
- Tooth site must have a natural tooth both mesially and distally in the adjacent tooth positions
- Opposing dentition of natural teeth, or tooth or implant-supported fixed restorations.
- Adequate bone quality and quantity at the implant site to permit the insertion of a Straumann P.004 SLActive implant of 8, 10, 12, or 14 mm length.
- Presence of a sufficient band of keratinized mucosa (min. 2 mm) to allow surgical manipulation and suturing according to the protocol
- Signed informed consent document before being treated in the study
Who cannot join
- Systemic disease that would interfere with dental implant therapy (e.g. uncontrolled diabetes)
- Any contraindications for oral surgical procedures
- Current untreated periodontitis or gingivitis
- Probing pocket depth of more than 4 mm at one of the adjacent teeth
- Mucosal diseases (e.g. erosive lichen planus)
- History of local irradiation therapy
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- Bone augmentation procedures if the procedure require healing time of more than 12 weeks after implant placement
- Implants in adjacent position to planned implant
- Severe bruxing or clenching habits
- Heavy smokers: Patients who smoke more than 20 cigarettes per day
- Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation.
- Patients with inadequate oral hygiene or unmotivated for adequate home care
- Secondary Exclusion Criteria at Implant Surgery:
- Lack of primary stability of the implant
- Inappropriate implant position to insert implants according to the prosthetic requirements.
- Patients with augmentation procedures requiring more than 12 weeks healing time.
Trial locations and contacts
11 sites in 7 countries.
11 sites in 7 countries
Germany4 sites
Prof. Wiltfang
Kiel, Schleswig-Holstein, 24105
Michael Gahlert
München, 80333
Katharinenhospital
Stuttgart, 70174
Private Universität Witten/ Herdecke
Witten/ Herdecke
United States2 sites
Dr. Jeffery Ganeles
Boca Raton, Florida, 33431
Dr. William C. Martin
Gainesville, Florida, 32610
About this study
Official title: Randomized, Controlled Clinical Study Comparing Submerged vs. Trans-mucosal Placement of P.004 Implants in the Anterior Maxilla and Mandible by Evaluation of the Change in Bone Level Between 1st Stage Surgery and 6 Months Post Surgery
The purpose of this study is To demonstrate that there is no difference in change in bone level around P.004 implants between 1st stage surgery and 6 months post surgery when transmucosal implant placement is compared to submerged implant placement
Read the detailed description
The primary objective of this study is to determine the level at which the bone can be maintained in relation to the implant shoulder for the P.004 two-stage implant when placed in a submerged or a trans-mucosal procedure in single tooth gaps in the anterior region. The primary parameter will be measured by radiography 26 weeks after loading of the implant.
- Conditions
- Jaw, Edentulous, Partially
- Being tested
- Straumann Bone Level Implant
- Keywords
- Dental Implant
- 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.
Straumann Bone Level ImplantDevice
Straumann Bone Level Implant, SLActive surface, diameter 4.1, length 8, 10, 12, and 14 mm
| Study group | Role | What they receive |
|---|---|---|
| Submerged healing | Active comparator | The Straumann Bone Level Implant(s) will be placed using a submerged healing treatment Receives: Device: Straumann Bone Level Implant |
| Trans-mucosal healing | Active comparator | The Straumann Bone Level Implant(s) will be placed using a trans-mucosal healing treatment Receives: Device: Straumann Bone Level Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Bone Level (Distance B) After 6 Months Compared to Baseline (=Surgery)
The primary aim is to measure the bone level change between mesial and distal aspects of the implant at 6 months post implantation. The reference point for the bone level measurement is the implant shoulder.
Measured: Baseline and 6 months
Secondary outcomes (2)
Implant Survival Rate
The percentage of implants that remain in place in the jaw.
Measured: 6 months
Implant Survival Rate
The percentage of implants that remain in place in the jaw.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2009 (estimated)
- Study startOct 2006
- Primary completionJun 2008
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Jaw, Edentulous, PartiallyStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Straumann AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christoph Hammerle, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00906425
- Sponsor's protocol ID
- CR 05/05
- Status last verified
- Mar 2016
- First submitted
- 19 May 2009
- Last updated
- 30 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Hammerle CHF, Jung RE, Sanz M, Chen S, Martin WC, Jackowski J; this multicenter study group; Ivanoff CJ, Cordaro L, Ganeles J, Weingart D, Wiltfang J, Gahlert M. Submerged and transmucosal healing yield the same clinical outcomes with two-piece implants in the anterior maxilla and mandible: interim 1-year results of a randomized, controlled clinical trial. Clin Oral Implants Res. 2012 Feb;23(2):211-219. doi: 10.1111/j.1600-0501.2011.02210.x. Epub 2011 Jul 4.
PubMed 21722188Cordaro L, Torsello F, Chen S, Ganeles J, Bragger U, Hammerle C. Implant-supported single tooth restoration in the aesthetic zone: transmucosal and submerged healing provide similar outcome when simultaneous bone augmentation is needed. Clin Oral Implants Res. 2013 Oct;24(10):1130-6. doi: 10.1111/j.1600-0501.2012.02521.x. Epub 2012 Jun 15.
PubMed 22697581
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled Clinical Study Comparing Submerged vs. Trans-mucosal Placement of P.004 Implants in the Anterior Maxilla and Mandible by Evaluation of the Change in Bone Level Between 1st Stage Surgery and 6 Months Post Surgery
- ClinicalTrials.gov ID
- NCT00906425
- Acronym / sponsor ID
- CR 05/05
- Conditions
- Jaw, Edentulous, Partially
- Keywords
- Dental Implant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Institut Straumann AGIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 21 May 2009 (estimated)
- Results
- Posted 31 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is To demonstrate that there is no difference in change in bone level around P.004 implants between 1st stage surgery and 6 months post surgery when transmucosal implant placement is compared to submerged implant placement
Detailed description
The primary objective of this study is to determine the level at which the bone can be maintained in relation to the implant shoulder for the P.004 two-stage implant when placed in a submerged or a trans-mucosal procedure in single tooth gaps in the anterior region. The primary parameter will be measured by radiography 26 weeks after loading of the implant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Submerged healing | Active comparator | Device: Straumann Bone Level ImplantThe Straumann Bone Level Implant(s) will be placed using a submerged healing treatment |
| Trans-mucosal healing | Active comparator | Device: Straumann Bone Level ImplantThe Straumann Bone Level Implant(s) will be placed using a trans-mucosal healing treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males and females >18 years of age.
- Implant placement planned in the anterior maxilla or mandible (FDI tooth numbers 21 - 25, 11 - 15, 31-35, 41-45).
- Tooth site must have a natural tooth both mesially and distally in the adjacent tooth positions
- Opposing dentition of natural teeth, or tooth or implant-supported fixed restorations.
- Adequate bone quality and quantity at the implant site to permit the insertion of a Straumann P.004 SLActive implant of 8, 10, 12, or 14 mm length.
Key exclusion criteria (16 listed)
- Systemic disease that would interfere with dental implant therapy (e.g. uncontrolled diabetes)
- Any contraindications for oral surgical procedures
- Current untreated periodontitis or gingivitis
- Probing pocket depth of more than 4 mm at one of the adjacent teeth
- Mucosal diseases (e.g. erosive lichen planus)
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 |
|---|---|---|
| Straumann Bone Level ImplantStraumann Bone Level Implant, SLActive surface, diameter 4.1, length 8, 10, 12, and 14 mm | Device | Submerged healing, Trans-mucosal healing |
Primary outcome
Mean Change in Bone Level (Distance B) After 6 Months Compared to Baseline (=Surgery)
Time frame: Baseline and 6 months
The primary aim is to measure the bone level change between mesial and distal aspects of the implant at 6 months post implantation. The reference point for the bone level measurement is the implant shoulder.
2 secondary outcomes
Implant Survival Rate
Time frame: 6 months
Implant Survival Rate
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21722188Hammerle CHF, Jung RE, Sanz M, Chen S, Martin WC, Jackowski J; this multicenter study group; Ivanoff CJ, Cordaro L, Ganeles J, Weingart D, Wiltfang J, Gahlert M. Submerged and transmucosal healing yield the same clinical outcomes with two-piece implants in the anterior maxilla and mandible: interim 1-year results of a randomized, controlled clinical trial. Clin Oral Implants Res. 2012 Feb;23(2):211-219. doi: 10.1111/j.1600-0501.2011.02210.x. Epub 2011 Jul 4.
- Results publication: PubMed 22697581Cordaro L, Torsello F, Chen S, Ganeles J, Bragger U, Hammerle C. Implant-supported single tooth restoration in the aesthetic zone: transmucosal and submerged healing provide similar outcome when simultaneous bone augmentation is needed. Clin Oral Implants Res. 2013 Oct;24(10):1130-6. doi: 10.1111/j.1600-0501.2012.02521.x. Epub 2012 Jun 15.
- Individual participant dataSharing planned: No
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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.
Christoph Hammerle principal investigator
University of Zurich
11 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Straumann Bone Level Implant in people with Jaw, Edentulous, Partially, run by Institut Straumann AG at 11 sites in 7 countries.
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 7 inclusion and 16 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 30 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Germany, United States, Australia, Italy, Spain and 2 more countries. 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?
Yes. Results are posted in the registry (first posted 31 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Change in Bone Level (Distance B) After 6 Months Compared to Baseline (=Surgery) (time frame: Baseline and 6 months). 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 NCT00906425, which also lists 2 linked publications.
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 30 Mar 2016.