Alveolar Bone Loss, Bone Resorption
Conditions
Keywords
Alveolar bone, Bone resorption, dental implants
Brief 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®)
Interventions
DRUGHuman-Spongiosa
after tooth extraction, the dental alveolus is filled with the bone substitute material (Human-Spongiosa) and covered with a membrane (mucoderm®)
DEVICEcollacone®
after tooth extraction, the dental alveolus is filled with the bone substitute material (collacone®) and covered with a membrane (mucoderm®)
Sponsors
Botiss Medical AG
University Medicine Greifswald
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
outcome assessors will be masked during the evaluation period. Subjects will be identified through their randomization number. Patients identification log is stored at the study site and only available to the investigator who is responsible of concealment of these information.
Intervention model description
assignment of patients to one of the two treatment arms will be carried out randomly. Randomization process will be monitored and carried out by the center of clinical studies coordination - University Medicine Greifswald. Assignment of patient will be only known to the investigator after blood and urine sample results fulfill the inclusion criteria.
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Extent of bone resorption | According to E9 guideline, the assumptions of the sample size calculation and the statistical analysis plan, which was approved by PEI we include all relevant time points, respective: T-1 (baseline), T2, T3, T5, T6, T7, T8 (see definition above) | The main objective is to measure the extent of resorption of the alveolar ridge bone following teeth extraction and alveolar management (socket preservation) and to compare the two authorized bone substitute materials: 1. Human Spongiosa, gefriergetrocknet, CHB + mucoderm® and 2. collacone® + mucoderm® through 3D surface scan. Definition of time points: T-1 = baseline T2 = 1 month after extraction T3 = 4.5 months after extraction = time point of implantation T5 = 1 month after implantation T6 = 3 months after implantation T7 = 6 months after implantation T8 = 9 months after implantation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Implants stability | 4.5 months after teeth extraction and socket preservation (T3) and 3 months after implantation (T6) | The implant stability will be measured 2 times throughout this clinical trial |
| Pink Esthetic Score | T-1 (baseline before teeth extraction), T1 (7-10 days after extraction), T2 (1 month after extraction), T3 (time of implantation; 4.5 months after extraction), T5, T6, T7 and T8 (respective 1, 3, 6 and 9 months after implantation) | Repeated measurement of the soft tissues changes throughout the clinical trial at eight times |
| Histologic bone investigation | 4.5 months after teeth extraction and socket preservation (T3) | A bone biopsy will be taken before insertion of the implant. The bone biopsy will be investigated for structure changes |
Countries
Germany
Outcome results
None listed