Alveolar Bone LossPhase 2NCT00519155
Pilot Study on MD05 in Comparison With Open Flap Debridement in Patients Undergoing Periodontal Surgery
A Phase 2 study testing MD05 and open flap debridement and Open flap debridement in people with Alveolar Bone Loss and Periodontal Bone Loss, run by Scil Technology GmbH at 1 site in Hungary.
Trial summary
The purpose of the study is to gain experience of safety and efficacy with MD05 in man in alveolar bone regeneration. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Alveolar Bone Loss, Periodontal Bone Loss
- What is being tested?
- MD05 and open flap debridement and Open flap debridement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteHungary
- Study dates
- Jul 2007to Nov 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 extraction of teeth with advanced intrabony periodontal defects at single rooted teeth without root concavities/furrows located in the maxilla and mandible (maxillary/mandibular premolars, maxillary incisors; presurgery probing depth ≥ 6 mm, intrasurgery defect depth ≥ 4 mm) or located the mesial or distal aspect of mandibular molar teeth without adjacent teeth (excluding defects also involving the furcation area).
- Teeth to be treated must be scheduled for extraction in a treatment plan established by clinicians unrelated to the study.
- Male and female patients, aged 18 - 75 years
- Patients must be non-smokers
- 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 must provide written informed consent
Who cannot join
- Women of childbearing potential, pregnant or lactating women
- Participation in another clinical study within 30 days prior to study start
- Previous participation in this study
- Legal incompetence or restricted legal competence
- Alcoholism, drug dependency, smoking
- Acute or chronic infection at the application site
Show all 24Show fewer
- Known infection with HIV, HBV, or HCV
- Severe allergic rhinitis which requires permanent medication
- Known intolerance of or hypersensitivity to ß-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 (AST and/or ALT over 2 times upper limit of normal)
- Impaired renal function (creatinine over 1.5 times upper limit of normal)
- Uncontrolled insulin-dependent diabetes mellitus (HbA1c > 7%)
- Clinically relevant symptoms of thyroid dysfunction
- Severe hypertension (RRdiast > 110 mmHg)
- Clinically relevant cardiovascular disease e.g., decompensated cardiac insufficiency, hemodynamically relevant heart valve defects, or myocardial infarction during the last three months
- Systemic bone disease or illness having influence in bone metabolism (e.g. Osteogenesis imperfecta, Paget's disease, Ehlers-Danlos disease, osteomalacia, renal osteodystrophia, hyperparathyroidism)
- Clinically relevant blood coagulation disorder
- Leukopenia < 3.500 leukocytes/µL
- Previous (within last 2 months before screening visit) or current treatment with systemic corticosteroids of more than 5 mg/day prednisone equivalent
- Previous or current therapy with drugs having any influence on bone metabolism such as calcitonin or parathormone (as teriparatid) within the last 6 months before screening visit, bisphosphonates or fluoride at least for 30 days within the last 12 months before screening visit
- Previous (within last 2 months before screening visit) or current treatment with immunosuppressant
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Department of Periodontology, Semmelweis University Budapest
Budapest, Budapest, 1085
About this study
Official title: Pilot Study on Safety and Explorative Efficacy of MD05 in Comparison With Open Flap Debridement in Patients Undergoing Periodontal Surgery to Treat Deep Intrabony Defects
The purpose of the study is to gain experience of safety and efficacy with MD05 in man in alveolar bone regeneration.
- Conditions
- Alveolar Bone Loss, Periodontal Bone Loss
- Being tested
- MD05 and open flap debridement, Open flap debridement
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MD05 and open flap debridementDrug
recombinant human GDF-5 coated onto ß-tricalcium phosphate
Open flap debridementProcedure or surgery
Open flap debridement alone
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Open flap debridement + MD05 Receives: Drug: MD05 and open flap debridement |
| 2 | Active comparator | Open flap debridement Receives: Procedure: Open flap debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of regeneration of alveolar bone.
Measured: October 2008
Secondary outcomes (1)
Evidence of uncompromised healing.
Measured: October 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2007 (estimated)
- Study startJul 2007
- Primary completionOct 2008 (estimated)
- Study completionNov 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone LossStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scil Technology GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- FGK Clinical Research GmbH
- Investigators
- Anton Sculean, Prof., Principal investigator, Department of Periodontology; Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00519155
- Sponsor's protocol ID
- Scil-MD05-C02
- Other IDs
- EudraCT-No.: 2006-005883-25
- Status last verified
- Apr 2008
- First submitted
- 21 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 Explorative Efficacy of MD05 in Comparison With Open Flap Debridement in Patients Undergoing Periodontal Surgery to Treat Deep Intrabony Defects
- ClinicalTrials.gov ID
- NCT00519155
- Acronym / sponsor ID
- Scil-MD05-C02
- Conditions
- Alveolar Bone Loss, Periodontal Bone Loss
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Scil Technology GmbHIndustry (pharma, biotech, devices)
- Collaborators
- FGK Clinical Research GmbH
- Study start
- Jul 2007
- Primary completion
- Oct 2008 (estimated)
- Study completion
- Nov 2008 (estimated)
- First posted
- 22 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 purpose of the study is to gain experience of safety and efficacy with MD05 in man in alveolar bone regeneration.
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: MD05 and open flap debridementOpen flap debridement + MD05 |
| 2 | Active comparator | Procedure: Open flap debridementOpen flap debridement |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients requiring extraction of teeth with advanced intrabony periodontal defects at single rooted teeth without root concavities/furrows located in the maxilla and mandible (maxillary/mandibular premolars, maxillary incisors; presurgery probing depth ≥ 6 mm, intrasurgery defect depth ≥ 4 mm) or located the mesial or distal aspect of mandibular molar teeth without adjacent teeth (excluding defects also involving the furcation area).
- Teeth to be treated must be scheduled for extraction in a treatment plan established by clinicians unrelated to the study.
- Male and female patients, aged 18 - 75 years
- Patients must be non-smokers
- 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.
Key exclusion criteria (24 listed)
- Women of childbearing potential, pregnant or lactating women
- Participation in another clinical study within 30 days prior to study start
- Previous participation in this study
- Legal incompetence or restricted legal competence
- Alcoholism, drug dependency, smoking
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 |
|---|---|---|
| MD05 and open flap debridementrecombinant human GDF-5 coated onto ß-tricalcium phosphate | Drug | 1 |
| Open flap debridementOpen flap debridement alone | Procedure or surgery | 2 |
Primary outcome
Evidence of regeneration of alveolar bone.
Time frame: October 2008
1 secondary outcome
Evidence of uncompromised healing.
Time frame: October 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.
Anton Sculean, Prof. principal investigator
Department of Periodontology; Radboud University Medical Center
1 site 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 open flap debridement and Open flap debridement in people with Alveolar Bone Loss and Periodontal Bone Loss, run by Scil Technology GmbH at 1 site in Hungary.
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 6 inclusion and 24 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 1 site in Hungary. 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?
Evidence of regeneration of alveolar bone. (time frame: October 2008). 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.