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

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.

Study Overview

• Status: Unknown
• Conditions: Periodontal Bone Loss; Alveolar Bone Loss
• Intervention / Treatment: Drug: MD05 and open flap debridement; Procedure: Open flap debridement

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary, 1085
    • Department of Periodontology, Semmelweis University Budapest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Open flap debridement + MD05	Drug: MD05 and open flap debridement; recombinant human GDF-5 coated onto ß-tricalcium phosphate
Active Comparator: 2; Open flap debridement	Procedure: Open flap debridement; Open flap debridement alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evidence of regeneration of alveolar bone.	October 2008

Secondary Outcome Measures

Outcome Measure	Time Frame
Evidence of uncompromised healing.	October 2008

Collaborators and Investigators

• Sponsor: Scil Technology GmbH
• Collaborators: FGK Clinical Research GmbH
• Investigators: Principal Investigator: Anton Sculean, Prof., Department of Periodontology; Radboud University Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Anticipated): October 1, 2008
• Study Completion (Anticipated): November 1, 2008

Study Registration Dates

• First Submitted: August 21, 2007
• First Submitted That Met QC Criteria: August 21, 2007
• First Posted (Estimate): August 22, 2007

Study Record Updates

• Last Update Posted (Estimate): April 23, 2008
• Last Update Submitted That Met QC Criteria: April 21, 2008
• Last Verified: April 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Bone Diseases; Periodontal Atrophy; Bone Resorption; Alveolar Bone Loss
• Other Study ID Numbers: Scil-MD05-C02; EudraCT-No.: 2006-005883-25