Randomized Clinical Trial, conventional treatment-controlled, studying the efficacy of Plasma Rich in Growth Factor (PRGF®) in alveolar ridge preservation after simple exodontia in the anterior region of maxilla.

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2019
INTERVENTION: Product Name: PRP Obtained by PRGF‐Endoret Pharmaceutical Form: Gel INN or Proposed INN: Platelet concentrate Other descriptive name: PLATELET CONCENTRATE Concentration unit: U unit(s) Concentration type: equal Concentration number: 1‐ CONDITION: Alveolar ridge preservation after exodontia of uniradiculate dental pience in the anterior region of maxilla Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] ‐ Dentistry [E06] PRIMARY OUTCOME: 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 Primary end point(s): Bone formation evaluated by histomorphometric analysis of the biopsies Secondary Objective: Not applicable Timepoint(s) of evaluation of this end point: 12 weeks after exodontia SECONDARY OUTCOME: ; 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; 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 < than 25% in the vestibular table ‐ Signing the informed content Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 56 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6
Epistemonikos ID: 7f0bf8f99c7f29488e83fb69b24aed1b4478e3a2
First added on: Aug 24, 2024