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 range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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