Transcrestal Sinus Lift With OSSIX Bone vs BIOSS Collagen (NCT07041411) | Clinical Trial Compass
CompletedNot Applicable
Transcrestal Sinus Lift With OSSIX Bone vs BIOSS Collagen
Italy26 participantsStarted 2022-11-10
Plain-language summary
Primary: Histologically analyse the quality of bone regeneration after graft material insertion in severely resorbed maxilla.
Secondary: Radiological analysis of the volume of the bone regenerations with the shirnkage rate of the graft material. clinical study of 20 patients 13 in OSSIX Bone group 13 in Bio-Oss Collagen group all patients requiring a regenerative procedure (sinus lift) having less than 3mm of residual bone height (RBH) with the impossibility to place the implants at the time of regenerative proc 6 months follow up for the first endpoint. (collection of the histological sample) 12 months follow up - long term clinical evaluation. tests performed: Cone Beam Computed Tomography (CBCT), clinical evaluation, X-ray
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Patient requiring vertical elevation of the maxillary sinus.
✓. Residual alveolar bone height of edentulous maxilla below the floor of the maxillary sinus of \< 3-4 mm.
✓. Males and females between 30-80 years old
✓. Patients with healthy periodontal conditions (Treated periodontitis, Plaque Index (PI) \<25%, Bleeding on Probing (BoP) \<25%).
✓. Patients that are willing to sign an informed consent and participate in a clinical Study.
✓. Generally fit and healthy and able to undergo oral surgical procedures under local anesthesia.
✓. Teeth at the surgical site which required removal were extracted a minimum of 12 weeks prior to sinus floor elevation.
Exclusion criteria
✕. Patient requiring vertical elevation of the maxillary sinus with native bone crest height \> 5 mm
✕. Patients who smoke over 5 cigarettes/day
What they're measuring
1
histological analysis
Timeframe: 6 months after graft insertion
Trial details
NCT IDNCT07041411
SponsorStudio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo