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

Alveolar Bone Loss Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00519155
• Other study ID #: Scil-MD05-C02
• Secondary ID: EudraCT-No.: 200
• Status: Active, not recruiting
• Phase: Phase 2
• First received: August 21, 2007
• Last updated: April 21, 2008
• Start date: July 2007
• Est. completion date: November 2008

Study information

• Verified date: April 2008
• Source: Scil Technology GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: National Institute of Pharmacy
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: November 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alveolar Bone Loss
• Periodontal Bone Loss

Intervention

Drug:
• MD05 and open flap debridement
recombinant human GDF-5 coated onto ß-tricalcium phosphate

Procedure:
• Open flap debridement
Open flap debridement alone

Locations

Country	Name	City	State
Hungary	Department of Periodontology, Semmelweis University Budapest	Budapest

Sponsors (2)

Lead Sponsor	Collaborator
Scil Technology GmbH	FGK Clinical Research GmbH

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence of regeneration of alveolar bone.		October 2008	No
Secondary	Evidence of uncompromised healing.		October 2008	Yes