Regenerative potential of L-PRF
Conditions
Interventions
Trade Name: L-PRF (INTRASPIN SYSTEM )
Product Name: L-PRF
Product Code: IS220
Pharmaceutical Form: Periodontal insert
INN or Proposed INN: leukocytes and platelet rich fibrin
Current Sponsor code: IS2
Sponsors
OMEQUI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients older than 18 years Presence of oral health with plaque index and bleeding not exceeding 25%. Need to perform dental extraction in anterosuperior zone involving teeth in position 15 - 25 (both included) Presence of more than 60% of the bone at the radiographic level 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 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Smokers of more than 20 cigarettes Presence of medical pathology that prevents the application of the treatments, has an impact on the response of these and the healing process: protein and vitamin deficiency, therapeutic radiation, metabolic disorders (diabetes, hypercalcemia ...), drug disorders (antimetabolic, immunosuppressive) And hormonal, allergy to some component of the treatments applied in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine if there are differences in the horizontal radiographic bone gain at 1 mm from the most coronal crestal portion by means of the Computed Tomography CT scan at 3 months after alveolar preservation post-extraction between two treatment modalities: the use of L- PRF or DBBM-C / PG (demineralized bovine bone mineral with collagen and covered by connective tissue graft);Secondary Objective: To estimate the possible differences between the modalities of preservation applied by CT by assessing the osseo-crest changes in the horizontal direction (vestibular, palatal and total crest) at 3 and 5 mm apical to the most coronal alveolar crest, and vertically (vestibular crest, palatine And midpoint of the socket). Likewise, we will analyze the volumetric crest changes observed when comparing previous study models and at 3 months post-extraction using image digitalization techniques. Assessment of postoperative morbidity, healing and adherence to postoperative guidelines given;Primary end point(s): Radiographic bone changes horizontally 1 mm from the crest (HW-1C);Timepoint(s) of evaluation of this end point: At baseline and at 3 months after treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): CLINICS: Ii) changes in alveoli depth in mm at 3 months of healing; Iii) dimensional changes at 3 months of healing among the study models obtained; Iv) evaluation of compliance with postoperative guidelines and intensity of pain after the intervention (1st and 2nd postoperative weeks); Vi) level of healing of the area involved, complications and level of oral hygiene (1st, 2nd and 12th week post-treatment); Age, sex, number of daily cigarettes consumed (evaluated at baseline); Extraction tooth position, dental extraction motif, periodontal biotype, antibiotic prophylaxis (evaluated on the day of treatment). RADIOGRAPHICS: (HW-3C and HW-5C) and changes in the thickness of each cortical for the 3 levels studied (BHW-1C, BHW-3C, BHW-5C: cortical Vestibular, PHW-1C, PHW-3C, PHW-5C: cortical palatine). Viii) vertical changes in vestibular and palatal ridge (BH and PH); Ix) vertical bone filling of the alveoli (AF).;Timepoint(s) of evaluation of this end point: RADIOGRÁFICAS: They are evaluated at the beginning and at 3 months post-treatment. CLINICS: Ii) changes in alveoli depth in mm at 3 months of healing; Iii) dimensional changes at 3 months of healing among the study models obtained; Iv) evaluation of compliance with postoperative guidelines and intensity of pain after the intervention (1st and 2nd postoperative weeks); Vi) level of healing of the area involved, complications and level of oral hygiene (1st, 2nd and 12th week post-treatment); Age, sex, number of daily cigarettes consumed (they would be evaluated at baseline); Extraction tooth position, dental extraction motif, periodontal biotype, antibiotic prophylaxis (they would be evaluated on the day of treatment). | — |
Countries
Spain
Contacts
Public ContactMaster of Periodontics. USC
University of Santiago de Compostela. Faculty of Medicine and Dentistry
Outcome results
None listed