Transcrestal Sinus Lift With OSSIX Bone vs BIOSS Collagen
NCT07041411 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26
Last updated 2025-06-27
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
Conditions
- Sinus Lift
- Graft Materials
- Transcrestal Approach
Interventions
- 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.
Sponsors & Collaborators
-
Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-11-10
- Primary Completion
- 2024-05-02
- Completion
- 2025-03-22
Countries
- Italy
Study Locations
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