Dental Implantation
Conditions
Keywords
exodontia, PRGF, Alveolar Ridge preservation
Brief summary
This Randomized Clinical Trial aims to study the efficacy and safety of PRGF-Endoret in alveolar ridge preservation after single molar extractions. The control group is the spontaneous healing occuring after the suturing of the alveolus. The primary endpoint is the bone regeneration measured in biopsies obtained from the regenerated alveolar bone.
Interventions
Filling of the alveolus with PRGF clot and fibrin plug.
DRUGBlood clot and simple suture
Filling the alveolus with blood clot
Sponsors
Fundación Eduardo Anitua
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age\> 18 years * Clinical indication for simple tooth extraction in the posterior sectors (from the second premolar to upper and lower second molars) * Need to place a dental implant in the same position of the extraction * Availability of observation during the period of treatment * Signature of the informed consent
Exclusion criteria
* Third molars * Active periodontal disease * Simultaneous extraction of two adjacent pieces in the same quadrant * Oral dehiscence ≥ 25% * Alveolus depth \<7mm * Loss of some wall of the alveolus * Severe inflammation in the extraction area * Previous diagnosis of coagulopathies * Previous diagnosis of autoimmune disease * Be receiving, or have received the 30 days prior to extraction treatment with radiotherapy, chemotherapy, immunosuppressants, systemic corticosteroids or anticoagulants * Regular treatment with NSAIDs * History of chronic hepatitis or liver cirrhosis * Positive markers for HCV, AfHBs, HIV-I / II or TP * Diabetes mellitus with poor metabolic control (evidence of glycated hemoglobin\> 9%) * Dialysis treatment * Presence of malignant tumors, hemangiomas or angioma in the extraction area. * History of ischemic heart disease in the last year * Pregnancy or women of childbearing age who do not take action contraceptives * Lactating women * Previous diagnosis of metabolic bone disease * Antiresorptive treatment * Treatment with monoclonal antibodies * Smoker\> 10 cigarettes / day * Any inability to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone regeneration | 12 weeks post-extraction | Quantity of new bone measured in bone biopsies obtained after alveolar ridge preservation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inflammation score | 3, 7 and 15 days post-extraction | Evolution of inflammation evaluated by ordinal scale from 0 to 3 (0=no inflammation; 3=severe inflammation) |
| Soft tissue healing index | 3, 7 and 15 days post-extraction | Soft tissue healing index according to the scale of Laundry. Values ranging 1 to 5 (1=poor healing, 5=excellent healing) |
| Changes in the dimension of the alveolar ridge | 12 weeks post-extraction | Changes in the dimension of the alveolar ridge by means of superimposition of digital files of models of plaster after 12 weeks post-extraction |
| Soft tissue histomorphometric changes | 12 weeks post-extraction | \- Soft tissue histomorphometric changes after evaluated by soft tissue biopsy |
| Visual Analogue Score (VAS) | 3, 7 and 15 days post-extraction | Evolution of pain assessed by the visual analog scale (VAS). Values ranging 0 to 10 (0=no pain and 10=worst pain) |
| Change in bone density | 12 weeks post-extraction | Change in bone density (Hounsfield units) evaluated by the CBCT at three different points between the post-extraction week and 12 weeks. |
| Vitamin D levels | 12 weeks post-extraction | — |
| Frequency of surgical and postsurgical complications | 12 weeks post-extraction | — |
| Change in the bone dimensions of the alveolar ridge | 12 weeks post-extraction | Change in the bone dimensions of the alveolar ridge evaluated by CBCT between the post-extraction day and the week 12 post-extraction. |
Countries
Spain
Outcome results
None listed