Bioactive Surfaces vs. Conventional Surfaces in Implants Placed in Atrophic Maxilla With Simultan… (NCT05500911) | Clinical Trial Compass
CompletedNot Applicable
Bioactive Surfaces vs. Conventional Surfaces in Implants Placed in Atrophic Maxilla With Simultaneous Sinus Lift
Italy36 participantsStarted 2022-04-22
Plain-language summary
In this controlled clinical study, a maxillary sinus lift (crestal approach) with OSSIX® Bone will be performed, and then implants MultiNeO CS (control group) and NINA MultiNeO NH (test group) will be inserted in edentulous posterior maxillae of study subjects. .+the clinical and radiographic results of the rehabilitation of posterior edentulous maxillary areas, obtained with traditional surface implants (MultiNeO CS, control group), are compared with those obtained with bioactive surface implants (NINA - MultiNeO NH, test group ).
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:
* edentulous posterior maxillae
* residual bone height \> 4mm
* healthy periodontal conditions
Exclusion Criteria:
* smokers over 5 cigarettes/day
* Pregnancy (confirmed by verbal inquiry)
* Chronic systemic pathologies and neoplastic of the Oro-Facial District
* bisphosphonates intake
* Any sites where an implant already failed sites
* Untreated Periodontitis
* Sites with acute infections
* Chronic inflammatory diseases of the oral cavity
* Autoimmune diseases (cortisone intake)
* Allergy declared to one or more medicaments to be used during treatment
* Alcoholics patients and/or drug addicts
* collagen hypersensitivity.
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
Marginal bone change
Timeframe: 6 months after implant placement
2
Marginal bone change
Timeframe: 12 months after implant placement
3
Implant stability
Timeframe: immediately after implant placement
4
Implant stability
Timeframe: 2 months after implant placement
5
Implant stability
Timeframe: 4 months after implant placement
6
insertion torque curve
Timeframe: During implant placement (T0 baseline
Trial details
NCT IDNCT05500911
SponsorStudio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo