Jaw, EdentulousNCT00901017
Comparison of Synthetic Bone Substitute and a Bovine-derived Xenograft in Horizontal Bone Augmentation
A study testing Straumann BoneCeramic and Bio-Oss in people with Jaw, Edentulous and Jaw, Edentulous, Partially, run by Institut Straumann AG at 1 site in Belgium.
Trial summary
The objective of the study is to test the efficacy on bone formation of Straumann Bone Ceramic as a grafting material applied in buccal bone dehiscences on simultaneously placed oral implants. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Jaw, Edentulous, Jaw, Edentulous, Partially
- What is being tested?
- Straumann BoneCeramic and Bio-Oss
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2006to Aug 2008
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females, 18 years to 80 years of age
- At least two missing teeth up to full edentulous arches.
- Desiring implant supported restorations.
- Both study implants should have a self-containing (2-wall) buccal dehiscence defect after oral implant placement (at least 3.0 mm / max. 5.0 mm defect in apico-coronal aspect to be measured from the boarder of the rough surface of the oral implant to the bottom of the defect).
- At least 4mm of the implant, measured from the apical end to the lowest margin of the bone level, should be covered with bone.
- Sufficient bone volume such that both oral implants will not encroach on vital structures and primary stability of the oral implant can be achieved;
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- Patients must be committed to the study and must sign informed consent.
- Patient in good general health as documented by self assessment;
- Full mouth plaque score of <20%;
Who cannot join
- Any systemic medical condition that could interfere with the surgical procedure or planned treatment;
- Current pregnancy or breast feeding/ lactating at the time of recruitment;
- Physical handicaps that would interfere with the ability to perform adequate oral hygiene;
- Alcoholism or chronically drug abuse causing systemic compromise.
- Patients who smoke more than 20 cigarettes per day.
- Conditions or circumstances, in the opinion of the investigator, which could represent a general contra-indication for surgical procedure or would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unreliability
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- Lack of primary stability of 1 or both implant(s) at surgery, measured by hand testing. In this instance the patient must be withdrawn and treated accordingly.
- Mucosal diseases such as erosive lichen planus
- History of local radiation therapy.
- Presence of osseous pathologies.
- Presence of oral lesions (such as ulceration, malignancy)
- Severe bruxing or clenching habits.
- Local inflammation, including untreated periodontitis.
- Bone surgery at the implant site(s) (bone grafts, guided tissue regeneration techniques for bone enhancement) prior to implant placement unless performed more than 6 months prior to implant placement.
- Patients presenting clinical and radiological signs and symptoms of maxillary sinus disease.
- Existing teeth in the residual dentition with untreated endodontic pathologies.
- Patients with inadequate oral hygiene or unmotivated for adequate home care
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Controlled Spilt-mouth Clinical Study Comparing a Synthetic Bone Substitute and a Bovine-derived Xenograft in Primarily Horizontal Bone Augmentation Procedure During Placement of Straumann Oral Implants
The objective of the study is to test the efficacy on bone formation of Straumann Bone Ceramic as a grafting material applied in buccal bone dehiscences on simultaneously placed oral implants.
Read the detailed description
This is a randomized, controlled, split mouth, prospective, single centre study. The total study duration for each patient should be 76 weeks +/-18 months.
In total 8 visits per patient are scheduled in this study.
The study devices Straumann Bone Ceramic and Bio-Oss are CE-marked, and approved by the FDA. The products are used within the indication.
One center in Beligum will participate.
- Conditions
- Jaw, Edentulous, Jaw, Edentulous, Partially
- Being tested
- Straumann BoneCeramic, Bio-Oss
- Medical subject headings
- Jaw, Edentulous, Jaw, Edentulous, Partially
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Straumann BoneCeramicDevice
Bone augmentation procedure performed with Bone Ceramic
Bio-OssDevice
Bone Augmentation procedure performed with Bio Oss
| Study group | Role | What they receive |
|---|---|---|
| Straumann BoneCeramic | Active comparator | Straumann BoneCeramic Receives: Device: Straumann BoneCeramic |
| Bio-Oss | Active comparator | Geistlich Bio-Oss Receives: Device: Bio-Oss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Vertical Height of Buccal Defects
Change of vertical height of buccal defects over 26 weeks, measured during 1st - and 2nd- stage surgery
Measured: Baseline to 26 weeks
Secondary outcomes (4)
Implant Success Rate
The success of oral implant will be determined according to the following parameters:
- Absence of any continuous peri-implant radiolucency based on radiographic findings.
- Absence of implant mobility (based on hand testing)
- Absence of a peri-implant infection with suppuration.
- Absence of a recurrent peri-implant infection with suppuration (where an infection is termed recurrent if it is observed at two or more follow-up visits after treatment with systemic antibiotics).
- Bone level changes evaluated on periapical radiographs around implants less than 1 mm during the first year of loading, starting at abutment connection.
Measured: 6 months
Implant Survival Rate
A surviving implant will be considered an implant fulfilling the following criteria:
- Absence of any continuous peri-implant radiolucency based on radiographic findings.
- Absence of implant mobility.
- Absence of a recurrent peri-implant infection with suppuration (where an infection is termed recurrent if it is observed at two or more follow-up visits after treatment with systemic antibiotics).
- Absence of pain or any other adverse observation by the patient, so that the implant has to be removed.
Measured: 6 Months
Implant Success Rate
The success of oral implant will be determined according to the following parameters:
- Absence of any continuous peri-implant radiolucency based on radiographic findings.
- Absence of implant mobility (based on hand testing)
- Absence of a peri-implant infection with suppuration.
- Absence of a recurrent peri-implant infection with suppuration (where an infection is termed recurrent if it is observed at two or more follow-up visits after treatment with systemic antibiotics).
- Bone level changes evaluated on periapical radiographs around implants less than 1 mm during the first year of loading, starting at abutment connection.
Measured: 12 months
Implant Survival Rate
A surviving implant will be considered an implant fulfilling the following criteria:
- Absence of any continuous peri-implant radiolucency based on radiographic findings.
- Absence of implant mobility.
- Absence of a recurrent peri-implant infection with suppuration (where an infection is termed recurrent if it is observed at two or more follow-up visits after treatment with systemic antibiotics).
- Absence of pain or any other adverse observation by the patient, so that the implant has to be removed.
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 posted13 May 2009 (estimated)
- Study startMar 2006
- Primary completionFeb 2008
- Study completionAug 2008
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.
- Other trials for Jaw, EdentulousStudies 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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Straumann AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marc Quirynen, Professor, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00901017
- Sponsor's protocol ID
- CR 04/05
- Status last verified
- Mar 2016
- First submitted
- 11 May 2009
- Last updated
- 30 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
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
- A Randomised Controlled Spilt-mouth Clinical Study Comparing a Synthetic Bone Substitute and a Bovine-derived Xenograft in Primarily Horizontal Bone Augmentation Procedure During Placement of Straumann Oral Implants
- ClinicalTrials.gov ID
- NCT00901017
- Acronym / sponsor ID
- CR 04/05
- Conditions
- Jaw, Edentulous, Jaw, Edentulous, Partially
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Institut Straumann AGIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Feb 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 13 May 2009 (estimated)
- Results
- Posted 5 Nov 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to test the efficacy on bone formation of Straumann Bone Ceramic as a grafting material applied in buccal bone dehiscences on simultaneously placed oral implants.
Detailed description
This is a randomized, controlled, split mouth, prospective, single centre study. The total study duration for each patient should be 76 weeks +/-18 months.
In total 8 visits per patient are scheduled in this study.
The study devices Straumann Bone Ceramic and Bio-Oss are CE-marked, and approved by the FDA. The products are used within the indication.
One center in Beligum will participate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Straumann BoneCeramic | Active comparator | Device: Straumann BoneCeramicStraumann BoneCeramic |
| Bio-Oss | Active comparator | Device: Bio-OssGeistlich Bio-Oss |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Males and females, 18 years to 80 years of age
- At least two missing teeth up to full edentulous arches.
- Desiring implant supported restorations.
- Both study implants should have a self-containing (2-wall) buccal dehiscence defect after oral implant placement (at least 3.0 mm / max. 5.0 mm defect in apico-coronal aspect to be measured from the boarder of the rough surface of the oral implant to the bottom of the defect).
- At least 4mm of the implant, measured from the apical end to the lowest margin of the bone level, should be covered with bone.
Key exclusion criteria (17 listed)
- Any systemic medical condition that could interfere with the surgical procedure or planned treatment;
- Current pregnancy or breast feeding/ lactating at the time of recruitment;
- Physical handicaps that would interfere with the ability to perform adequate oral hygiene;
- Alcoholism or chronically drug abuse causing systemic compromise.
- Patients who smoke more than 20 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 |
|---|---|---|
| Straumann BoneCeramicBone augmentation procedure performed with Bone Ceramic | Device | Straumann BoneCeramic |
| Bio-OssBone Augmentation procedure performed with Bio Oss | Device | Bio-Oss |
Primary outcome
Change of Vertical Height of Buccal Defects
Time frame: Baseline to 26 weeks
Change of vertical height of buccal defects over 26 weeks, measured during 1st - and 2nd- stage surgery
4 secondary outcomes
Implant Success Rate
Time frame: 6 months
Implant Survival Rate
Time frame: 6 Months
Implant Success Rate
Time frame: 12 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.
- 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.
Marc Quirynen, Professor principal investigator
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Straumann BoneCeramic and Bio-Oss in people with Jaw, Edentulous and Jaw, Edentulous, Partially, run by Institut Straumann AG at 1 site in Belgium.
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 9 inclusion and 17 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 1 site in Belgium. 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 5 Nov 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?
Change of Vertical Height of Buccal Defects (time frame: Baseline to 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.