Investigation of the volume stability of the alveolar ridge, the bonestructure and soft tissue appearance at a delayed dental implantationusing bone regeneration materials (Human-Spongiosa, gefriergetrocknet,CHB; collacone®)

Phase 1

Conditions: alveolar ridge atrophy
MedDRA version: 19.0Level: PTClassification code 10074846Term: Alveolar bone resorptionSystem Organ Class: 10017947 - Gastrointestinal disorders
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Dentistry [E06]

Registration Number: EUCTR2015-001434-16-DE

Lead Sponsor: niversity of Medicine Greifswald

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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
- Normotonia blood pressure (according to the WHO definition):
* Men: 110/70 – 140/90 mm Hg
* Women: 100/60- 140/90mm Hg
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 (Warfirin, 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)