Dental Implantation
Conditions
Keywords
exodontia, PRGF, alveolar ridge preservation
Brief summary
This RCT aims to study the efficacy and safety of PRGF-Endoret in alveolar ridge preservation in the aesthetic zone. 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
PROCEDUREExodontia
Atraumatic exodontia followed by simple suture
Filling of the alveolus with PRGF clot and fibrin plug.
DEVICEPreparation of PRGF using Endoret technology
Preparation of PRGF using Endoret technology following manufacturer instructions
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
* \- Subjects of both sexes with an age greater than or equal to 18 years. * Clinical indication for a simple exodontia in the aesthetic zone (from left 2nd premolar to the right 2nd premolar in the maxilla). * Need of a dental implant placement in the extraction site. * Availability to follow-up during the treatment period * Subjects with non-active periodontal disease. * Buccal dehiscence \< than 25% in the vestibular table
Exclusion criteria
* \- Presence of an active infection * Loss of any plate of the socket * Severe inflammation in the area of the exodontia previous to the intervention * Have previous diagnosis of a coagulopathy. * Have previous diagnosis of any autoinmune disease. * Have received radiotherapy, chemotherapy or immunosuppressive treatments, systemic corticosteroids and/or anticoagulants the 30 days prior to inclusion * Regular treatment with AINES or other antiinflammatory drugs * Previous history of chronic hepatitis or heatic cirrhosis * Positive markers for VHC, AgHBs, VIH I/II or Treponema pallidum * Uncontrolled diabetes mellitus (Glycosylated hemoglobin higher than 9%) * Subjects submitted to hemodyalisis * Presence of malignant tumour, haemangiomas or angioma in the exodontia region. * Previous history of ischemic cardiopathy in the last year. * Pregnancy or womens in childbearing age who do not take contraception measures. * Nursing womens * Metabolic bone disease * Ongoing treatment with biphosphonates both through oral or intravenous administration * Smoking habits (\> 10 cigarrettes/day) * In general, any disability to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone regeneration | 12 months | Quantity of new bone measured in bone biopsies obtained after alveolar ridge preservation |
Countries
Spain
Outcome results
None listed