Collagenic vs Collagen-enriched Graft in Sinus Elevation: RCT (NCT07386184) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Collagenic vs Collagen-enriched Graft in Sinus Elevation: RCT
24 participantsStarted 2026-03-19
Plain-language summary
The goal of this clinical trial is to histologically understand if collagenic or collagen enriched graft in sinus lift of healthy volunteers needing for implants in the posterior maxillae may work. The main question it aims to answer are:
which material works better histologically and radiologically? Researchers will compare a collagenic graft to collagen enriched graft to see if the osteointegration of the material is the same.
Participants will undergo a sinus lift with one of the two materials and after six month will undergo a bone sample collection to allow the implant insertion.
twelve moths thereafter, a radiograph will be taken to measure the extension of the bone regeneration and implant behavior
Who can participate
Age range
30 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 floor.
* Residual alveolar bone height of edentulous maxilla below the floor of the maxillary sinus \<5 mm.
* Males and females between 30-80 years old
* Patients with healthy periodontal conditions (treated periodontitis, PI\<25%, BoP\<25%).
* Patients 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 requiring extraction were removed at least 12 weeks prior to sinus floor elevation.
Exclusion Criteria:
* Patients who smoke more than 5 cigarettes/day
* Pregnancy (confirmed by verbal inquiry)
* Chronic systemic pathologies (e.g. diabetes) and neoplasms of the oro-facial district.
* Patients undergoing treatment with antiresorptive agents.
* Patients receiving systemic corticosteroid therapy.
* Any site with a history of implant failure.
* Dental sites with acute infections.
* Chronic inflammatory diseases of the oral cavity.
* Autoimmune diseases.
* Documented hypersensitivity to any of the medications intended for use during the treatment protocol.
* Substance abusers.
* Patients with known collagen hypersensitivity.
* Patients with hypersensitivity to porcine-derived materials.
* History of malignant tumors of the maxillary sinus.
* History of head/neck radiation therapy.
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
histomorphometric analysis
Timeframe: 6 months
2
histologic analysis
Timeframe: 6 months
Trial details
NCT IDNCT07386184
SponsorStudio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo