Alveolar ridge preservation after exodontia of uniradiculate dental pience in the anterior region of maxilla
Conditions
Interventions
Product Name: PRP Obtained by PRGF-Endoret
Pharmaceutical Form: Gel
INN or Proposed INN: Platelet concentrate
Other descriptive name: PLATELET CONCENTRA
Sponsors
BTI I MAS D
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subjects of both sexes with an age greater than or equal to 18 years. - Clinical indication for a simple exodontia of a uniradicular tooth in the superior maxilla - Availability to follow-up during the treatment period - Subjects with non-active periodontal disease. - Buccal dehiscence =65 years) yes F.1.3.1 Number of subjects for this age range 6
Exclusion criteria
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 - Suffer any severe hematologic disease o disorder - 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 - 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 |
|---|---|
| Secondary Objective: Not applicable;Primary end point(s): Bone formation evaluated by histomorphometric analysis of the biopsies;Timepoint(s) of evaluation of this end point: 12 weeks after exodontia;Main Objective: Evaluate the efficacy of Plasma Rich in Growth Factors (PRGF®) in alveolar ridge preservation after simple exodontia of uniradiculate dental piece in the anteiror region of the maxilla | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1- Dimensional changes in the alveolar ridge measured by superimposition of the digital archives of the plaster cast 2- Dimensional bone changes in the alveolar ridge measured by CBCT usin the BTI scan software. 3- Bone density mesured in Hounsfield units measured in 3 points after analysis using BTI scan 4- Alveolar ridge width mesuared with periodontal probe. 5- Measures using periodontal probe. Vertical measures from the top of the mouthguard to the first bone-contact in the center of the vestibular and lingual tables and to the mesiobucal, distobucal, mesiolingual and distolingual points. 6- Pain during the recent post-surgery mesuared with the visual analogue scale (VAS). 7- Laundry Soft-tissue healing scale 8- Inflammation with the following ordinal scale: 0. Absence of inflammation 1. Slight swelling and hardness without facial planes blurring. 2. Facial planes blurring without affectation of nasolabial folds or eyes. 3. Facial planes blurring with affectation of nasolabial folds and eyes. ; Timepoint(s) of evaluation of this end point: 1- After the exodontia and 12 weeks after 2- After the exodontia and 12 weeks after 3- 12 weeks after exodontia 4- After exodontia, 3 and 7 days after and 12 weeks after 5- After exodontia, 3 and 7 days after and 12 weeks after 6- 3, 7 and 15 days after exodontia 7- 3, 7 and 15 days after exodontia and 4 weeks after exodontia 8- 3, 7 and 15 days after exodontia | — |
Countries
Spain
Contacts
Public ContactClinical Affairs
BTI I mas D
Outcome results
None listed