Pilot Study on MD05 in Comparison With Open Flap Debridement in Patients Undergoing Periodontal Surgery

Scil Technology

Status and phase

Unknown

Phase 2

Conditions

Alveolar Bone Loss

Periodontal Bone Loss

Treatments

Drug: MD05 and open flap debridement

Procedure: Open flap debridement

Study type

Interventional

Funder types

Industry

Identifiers

NCT00519155

EudraCT-No.: 2006-005883-25

Scil-MD05-C02

Details and patient eligibility

About

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

Enrollment

20 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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