Clinical trial NCT00519155: Pilot Study on MD05 in Comparison With Open Flap Debridement in Patients Undergoing Periodontal Surgery
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Alveolar Bone Loss
Periodontal Bone Loss
Lead sponsor: Scil Technology GmbH
Sponsor class: INDUSTRY
Collaborators: name: FGK Clinical Research GmbH
First posted: 2007-08-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to gain experience of safety and efficacy with MD05 in man in alveolar bone regeneration.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Evidence of regeneration of alveolar bone.
timeFrame: October 2008
Secondary outcomes:
measure: Evidence of uncompromised healing.
timeFrame: October 2008
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Department of Periodontology, Semmelweis University Budapest
Study officials:
affiliation: Department of Periodontology; Radboud University Medical Center
name: Anton Sculean, Prof.
role: PRINCIPAL_INVESTIGATOR
References: