Alveolar Management Following Teeth Extraction

University Medicine Greifswald

Status and phase: Terminated; Phase 4

Conditions: Alveolar Bone Loss; Bone Resorption

Treatments: Device: collacone®; Drug: Human-Spongiosa

Study type: Interventional

Funder types: Other

Identifiers

NCT03089619

2015-001434-16 (EudraCT Number)

3D_CHB/collacone

Details and patient eligibility

About

Investigation of the volume stability of the alveolar ridge, the bone structure and soft tissue appearance at a delayed dental implantation using two bone substitute materials (1. Human-Spongiosa, gefriergetrocknet, CHB; 2. collacone®)

Enrollment: 21 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed informed consent

• Indication for tooth extraction resulting in a edentulous gap

• Male and female patients with an age range 20-60 years

• Caucasian

• For female patients: a negative pregnancy test

• Normotonic blood pressure (according to the WHO definition):

  • Men: 110/70 - 140/90 mm Hg
  • Women: 100/60- 140/90mm Hg

Exclusion criteria

• Parallel implantation of another implant
• Parallel planned prosthetic restoration of the adjacent teeth
• Smoker (less than 5 years non-smoker)
• Nursing women
• Participation in another clinical trial which dates back to less than 3 months before inclusion in this clinical trial
• Intake of bisphosphonates
• Radiation therapy (medical history or current)
• Known Diabetes mellitus
• Inflammatory processes in the mouth (PSI> 2)
• Presence of autoimmune diseases (Rheumatoid arthritis, Sjögren's syndrome, Systemic lupus erythematosus)
• Presence of blood coagulation disorders (Haemophilia A/B), or the intake of anticoagulants (Warfarin, new oral anticoagulants, aspirin> 100 mg)
• Osteogenesis imperfecta
• Osteoporosis
• Leukemia
• Agranulocytosis
• Immunocompromised patients
• Acute phase and rehabilitation phase of myocardial infarction
• Oncogenes diseases
• Patients undergoing chemotherapy
• Sepsis
• Acute and chronic infections: sinusitis, rhinitis, pharyngitis and Otitis media
• Wound healing disorders
• Seizures
• Gingival hyperplasia
• Alcohol abuse
• Drug abuse
• Infectious diseases (HIV, Hepatitis B and C)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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21 participants in 2 patient groups

Human-Spongiosa (IMP: drug)

Active Comparator group

Description:

Product Name: Human-Spongiosa,gefriergetrocknet, CHB / Pharmaceutical form: Granules / Routes of Administration: Dental use / Marketing authorisation number : 3004134.00.00 / Marketing Authorisation Holder: Institute of Transfusion Medicine, Tissue bank, Charité university of medicine Berlin / Used by socket preservation

Treatment:

Drug: Human-Spongiosa

collacone® (IMP: medical device)

Active Comparator group

Description:

Product Name: Collacone / Pharmaceutical form: Absorbable, local Hemostat, porcine collagen / Routes of Administration: Dental use / Medical device with a CE mark / Used by socket preservation

Treatment:

Device: collacone®