Alveolar Management Following Teeth Extraction

Study Overview
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Brief Summary
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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®)

Official Title
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A Method for Measuring Volume Changes of the Alveolar Ridge During Dental Implantation Using 3D Scanning

Conditions
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Alveolar Bone Loss, Bone Resorption

Intervention / Treatment
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* Drug: Human-Spongiosa
* Device: collacone®


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Human-Spongiosa (IMP: drug)<br>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 | Drug: Human-Spongiosa<br>* after tooth extraction, the dental alveolus is filled with the bone substitute material (Human-Spongiosa) and covered with a membrane (mucoderm®)<br>* Other names: Knochenspongiosa of human origin;|
| Active Comparator: collacone® (IMP: medical device)<br>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 | Device: collacone®<br>* after tooth extraction, the dental alveolus is filled with the bone substitute material (collacone®) and covered with a membrane (mucoderm®)<br>* Other names: porcine collagen;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extent of bone resorption | 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: Human Spongiosa, gefriergetrocknet, CHB + mucoderm® and 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 | 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implants stability | The implant stability will be measured 2 times throughout this clinical trial | 4.5 months after teeth extraction and socket preservation (T3) and 3 months after implantation (T6) | 
| Pink Esthetic Score | Repeated measurement of the soft tissues changes throughout the clinical trial at eight times | 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) | 
| Histologic bone investigation | A bone biopsy will be taken before insertion of the implant. The bone biopsy will be investigated for structure changes | 4.5 months after teeth extraction and socket preservation (T3) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alveolar bone, Bone resorption, dental implants