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

NCT ID: NCT00519155

Last Updated: 2008-04-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2008-11-30

Brief Summary

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Open flap debridement + MD05

Group Type: EXPERIMENTAL

MD05 and open flap debridement

Intervention Type: DRUG

recombinant human GDF-5 coated onto ß-tricalcium phosphate

2

Open flap debridement

Group Type: ACTIVE_COMPARATOR

Open flap debridement

Intervention Type: PROCEDURE

Open flap debridement alone

Interventions

MD05 and open flap debridement

recombinant human GDF-5 coated onto ß-tricalcium phosphate

Intervention Type: DRUG

Open flap debridement

Open flap debridement alone

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

FGK Clinical Research GmbH

INDUSTRY

Sponsor Role: collaborator

Scil Technology GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Scil Technology GmbH

Principal Investigators

Anton Sculean, Prof.

Role: PRINCIPAL_INVESTIGATOR

Department of Periodontology; Radboud University Medical Center

Locations

Department of Periodontology, Semmelweis University Budapest

Budapest, Budapest, Hungary

Countries

Hungary

Other Identifiers

EudraCT-No.: 2006-005883-25

Identifier Type: -

Identifier Source: secondary_id

Scil-MD05-C02

Identifier Type: -

Identifier Source: org_study_id