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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
44
Filling of the alveolus with PRGF clot and fibrin plug.
Filling the alveolus with blood clot
Clinica Eduardo Anitua
Vitoria-Gasteiz, Spain
Bone regeneration
Quantity of new bone measured in bone biopsies obtained after alveolar ridge preservation
Time frame: 12 weeks post-extraction
Visual Analogue Score (VAS)
Evolution of pain assessed by the visual analog scale (VAS). Values ranging 0 to 10 (0=no pain and 10=worst pain)
Time frame: 3, 7 and 15 days post-extraction
Inflammation score
Evolution of inflammation evaluated by ordinal scale from 0 to 3 (0=no inflammation; 3=severe inflammation)
Time frame: 3, 7 and 15 days post-extraction
Soft tissue healing index
Soft tissue healing index according to the scale of Laundry. Values ranging 1 to 5 (1=poor healing, 5=excellent healing)
Time frame: 3, 7 and 15 days post-extraction
Changes in the dimension of the alveolar ridge
Changes in the dimension of the alveolar ridge by means of superimposition of digital files of models of plaster after 12 weeks post-extraction
Time frame: 12 weeks post-extraction
Soft tissue histomorphometric changes
\- Soft tissue histomorphometric changes after evaluated by soft tissue biopsy
Time frame: 12 weeks post-extraction
Change in the bone dimensions of the alveolar ridge
Change in the bone dimensions of the alveolar ridge evaluated by CBCT between the post-extraction day and the week 12 post-extraction.
Time frame: 12 weeks post-extraction
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Change in bone density
Change in bone density (Hounsfield units) evaluated by the CBCT at three different points between the post-extraction week and 12 weeks.
Time frame: 12 weeks post-extraction
Vitamin D levels
Time frame: 12 weeks post-extraction
Frequency of surgical and postsurgical complications
Time frame: 12 weeks post-extraction