Overview

Alveolar Management Following Teeth Extraction

Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
0
Participant gender:
All
Summary
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®)
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University Medicine Greifswald
Collaborator:
Botiss Medical AG
Criteria
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)