Alveolar Ridge AugmentationPhase 2NCT00520377
Pilot Study on Safety and Efficacy of MD05 in Comparison With Beta-TCP in Patients Undergoing Sinus Floor Augmentation
A Phase 2 study testing MD05 and Beta-TCP and autologous bone in people with Alveolar Ridge Augmentation, run by Scil Technology GmbH at 9 sites in Germany.
Trial summary
The primary objective is the area of newly formed bone (%) as assessed by histomorphometry with either MD05 or beta-TCP. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Alveolar Ridge Augmentation
- What is being tested?
- MD05 and Beta-TCP and autologous bone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 9 sitesGermany
- Study dates
- Jan 2005to May 2008
- Phase
- Phase 2
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients requiring two-stage unilateral maxillary sinus floor augmentation (sinus lift) in case of insufficient bone height in the area of the posterior maxilla, prior to insertion of dental implants
- Residual bone height at the site of planned implantation > 1 mm and < 5 mm
- Male and female outpatients, 18 to 75 years old
- Female patients must be infertile (either sterilized or postmenopausal). If a patient's menopausal status at screening is uncertain, levels of follicle stimulating hormone (FSH) should be determined. Patients with an FSH level > 25 IU/l and absence of menstrual bleeding > 6 months will satisfy the definition of postmenopausal status.
- Patient has given informed consent.
Who cannot join
- Women of childbearing potential, lactating women
- Participation in another clinical study within 30 days prior to study start
- Previous participation in this study
- Last dental extraction (maxilla, posterior to canine) within the last 3 months
- Failed sinus lift surgery and previous eradictive maxillary sinus surgery
- Simultaneously bilateral sinus lift
Show all 27Show fewer
- Legal incompetence or restricted legal competence
- Alcoholism, drug dependency, smoking
- Acute or chronic infection at the application site, e.g., sinusitis
- Known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)
- Severe allergic rhinitis which requires permanent medication (Rosenlicht 1999)
- Known intolerance of or hypersensitivity to beta-TCP or rhGDF-5
- Presence of local or systemic malignant disease or history of local or systemic malignant disease in the past 5 years
- Patients requiring chemo- or radiotherapy
- Previous or current radiotherapy of the head
- Chronic liver disorder
- Impaired renal function
- Uncontrolled, insulin-dependent diabetes mellitus
- Clinically relevant symptoms of thyroid dysfunction
- Severe hypertension (RRdiast > 110 mmHg);
- Clinically relevant cardiovascular disease
- Systemic bone disease or illness having influence on bone metabolism,
- Clinically relevant blood coagulation disorder,
- Leukopenia < 3.500 leukocytes/µL
- Previous or current treatment with systemic corticosteroids
- Previous or current therapy with drugs having any influence on bone metabolism
- Previous or current treatment with immunosuppressant medication
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Germany9 sites
Charité Universitätsmedizin Berlin
Berlin, State of Berlin, 12203
Universitätsklinik Düsseldorf
Düsseldorf, North Rhine-Westphalia, 40225
Helios Klinik
Erfurt, Thuringia, 99089
Universitätsklinik Erlangen
Erlangen, Bavaria, 91054
Universitätsklinikum Schleswig Holstein
Kiel, Schleswig-Holstein, 24105
Klinikum der Universität Mainz
Mainz, Rheinland Pflaz, 55131
Praxis Dr. Gath
München, Bavaria, 80336
IPI München GmbH
München, Bavaria, 81925
Praxis Dr. Schmidinger
Seefeld, Bavaria, 82229
About this study
The primary objective is the area of newly formed bone (%) as assessed by histomorphometry with either MD05 or beta-TCP.
- Conditions
- Alveolar Ridge Augmentation
- Being tested
- MD05, Beta-TCP and autologous bone
- Keywords
- Sinus Lift Surgery, Sinus Floor Augmentation, Insufficient Bone Height
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MD05Drug
recombinant human GDF-5 coated onto beta-tricalcium phosphate
Beta-TCP and autologous boneDevice
beta-tricalcium phosphate and autologous bone
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | MD05 Receives: Drug: MD05 |
| 2 | Active comparator | Beta-TCP and autologous bone Receives: Device: Beta-TCP and autologous bone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area of newly formed mineralised bone tissue (%) as assessed by histomorphometry.
Measured: Within 4 months after surgery
Secondary outcomes (1)
evidence of uncompromised healing
Measured: January 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2007 (estimated)
- Study startJan 2005
- Primary completionDec 2007
- Study completionMay 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Ridge AugmentationStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scil Technology GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- FGK Clinical Research GmbH
- Investigators
- Wilfried Wagner, Prof Dr Dr, Principal investigator, Universitätsklinikum Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00520377
- Sponsor's protocol ID
- Scil-MD05-C01
- Other IDs
- Sinus Lift Study
- Status last verified
- Apr 2008
- First submitted
- 23 Aug 2007
- Last updated
- 23 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on Safety and Efficacy of MD05 in Comparison With Beta-TCP in Patients Undergoing Sinus Floor Augmentation
- ClinicalTrials.gov ID
- NCT00520377
- Acronym / sponsor ID
- Scil-MD05-C01
- Conditions
- Alveolar Ridge Augmentation
- Keywords
- Sinus Lift Surgery, Sinus Floor Augmentation, Insufficient Bone Height
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Scil Technology GmbHIndustry (pharma, biotech, devices)
- Collaborators
- FGK Clinical Research GmbH
- Study start
- Jan 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- May 2008 (estimated)
- First posted
- 24 Aug 2007 (estimated)
- 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.
The primary objective is the area of newly formed bone (%) as assessed by histomorphometry with either MD05 or beta-TCP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: MD05MD05 |
| 2 | Active comparator | Device: Beta-TCP and autologous boneBeta-TCP and autologous bone |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients requiring two-stage unilateral maxillary sinus floor augmentation (sinus lift) in case of insufficient bone height in the area of the posterior maxilla, prior to insertion of dental implants
- Residual bone height at the site of planned implantation > 1 mm and < 5 mm
- Male and female outpatients, 18 to 75 years old
- Female patients must be infertile (either sterilized or postmenopausal). If a patient's menopausal status at screening is uncertain, levels of follicle stimulating hormone (FSH) should be determined. Patients with an FSH level > 25 IU/l and absence of menstrual bleeding > 6 months will satisfy the definition of postmenopausal status.
- Patient has given informed consent.
Key exclusion criteria (27 listed)
- Women of childbearing potential, lactating women
- Participation in another clinical study within 30 days prior to study start
- Previous participation in this study
- Last dental extraction (maxilla, posterior to canine) within the last 3 months
- Failed sinus lift surgery and previous eradictive maxillary sinus surgery
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 |
|---|---|---|
| MD05recombinant human GDF-5 coated onto beta-tricalcium phosphate | Drug | 1 |
| Beta-TCP and autologous bonebeta-tricalcium phosphate and autologous bone | Device | 2 |
Primary outcome
Area of newly formed mineralised bone tissue (%) as assessed by histomorphometry.
Time frame: Within 4 months after surgery
1 secondary outcome
evidence of uncompromised healing
Time frame: January 2008
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2008.
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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.
Wilfried Wagner, Prof Dr Dr principal investigator
Universitätsklinikum Mainz
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MD05 and Beta-TCP and autologous bone in people with Alveolar Ridge Augmentation, run by Scil Technology GmbH at 9 sites in Germany.
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 5 inclusion and 27 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: status not confirmed, as of the sponsor's last update on 23 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Area of newly formed mineralised bone tissue (%) as assessed by histomorphometry. (time frame: Within 4 months after surgery). 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 23 Apr 2008.