Transcrestal Sinus Lift With OSSIX Bone vs BIOSS Collagen

Not Applicable

Completed

• Conditions: Sinus Lift; Graft Materials; Transcrestal Approach

• Registration Number: NCT07041411
• Lead Sponsor: Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo

Brief 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.

Study Timeline

• Study Start: 2022-11-10
• Primary Completion: 2024-05-02
• Study Completion: 2025-03-22
• Study First Submitted: 2025-05-22
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-19
• Last Update Submitted: 2025-06-19
• Study First Posted: 2025-06-27
• Last Update Posted: 2025-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
histological analysis	6 months after graft insertion	samples were collected and histologically and immunohistologically analyzed

Secondary Outcome Measures

Name	Time	Method
radiological analyis	12 months	preoperatively Cone Beam Computed Tomography (CBCT) was compared to 12 months CBCT. The volume of bone regeneration was measured by performing a semi-automatic segmentation using a specific segmentation software (3D Slicer) and measured in mm3.

Trial Locations

Locations (1)

Studi Odontoiatrici Luigi Canullo; 🇮🇹 Roma, RM, Italy