A Method for Measuring Volume Changes of the Alveolar Ridge During Dental Implantation Using 3D Scanning
Overview
- Phase
- Phase 4
- Intervention
- Human-Spongiosa
- Conditions
- Alveolar Bone Loss
- Sponsor
- University Medicine Greifswald
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- Extent of bone resorption
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
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®)
Investigators
Eligibility 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)
Arms & Interventions
Human-Spongiosa (IMP: drug)
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
Intervention: Human-Spongiosa
collacone® (IMP: medical device)
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
Intervention: collacone®
Outcomes
Primary Outcomes
Extent of bone resorption
Time Frame: 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 Outcomes
- 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))
- Implants stability(4.5 months after teeth extraction and socket preservation (T3) and 3 months after implantation (T6))
- Histologic bone investigation(4.5 months after teeth extraction and socket preservation (T3))