NCT07041411

Transcrestal Sinus Lift With OSSIX Bone vs BIOSS Collagen

Histological and Radiological Evaluation of Crosslinked vs Not Cross Linked Graft in Transcretal Sinus Elevation in Severely Resorbed Maxilla. A Prospective, Controlled Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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

Detailed description

Visit 1 - Screening Visit - preoperative visit (informed consent, dental mouth cleaning, CBCT, intraoral scanning). Visit 2 - Baseline visit - T0 (surgical procedure) Sinus elevation with OSSIX® Bone or Bio-Oss® Collagen, periapical x-ray, intraoral photo with microscope. Visit 3 - Follow up visit - 14 days - suture removal, clinical evaluation and patient satisfaction questionnaire. Visit 4 - Follow up visit - 180days (One week before) Cone Beam Computed Tomography (CBCT), Dental mouth cleaning, intraoral scanning. (Second surgery) implant site preparation and histological sample collection, implant placement, insertion torque value, implant stability, peri-apical x-ray, intraoral scanning and photography. Visit 5 - Follow up visit - 194 days suture removal and clinical evaluation. Visit 6 - Follow up visit - 270 days Implant stability, clinical examination, definitive restoration and periapical x-ray Visit 7- Follow up visit - 365 days Implant stability, peri-apical x-ray, definitive restoration, Cone Beam Computed Tomography (CBCT), intraoral scanning and picture.

Conditions

• Sinus Lift
• Graft Materials
• Transcrestal Approach

Interventions

Type	Name	Description
PROCEDURE	maxillary sinus elevation through transcrestal approach using OSSIX® Bone	After a careful radiologic analysis, using a surgical guide, maxillary sinus elevation through transcrestal access to sinus mucosa was achieved. The elevation of the maxillary sinus mucosa was performed through micro-elevators and graft material was inserted.

Timeline

• Start date: 2022-11-10
• Primary completion: 2024-05-02
• Completion: 2025-03-22
• First posted: 2025-06-27
• Last updated: 2025-06-27

Locations

1 site across 1 country: Italy