4 vs 6 Implants in Totally Edentulous Patient in Maxilla With Ti. Cad-cam Framework (NCT02405169) | Clinical Trial Compass
CompletedNot Applicable
4 vs 6 Implants in Totally Edentulous Patient in Maxilla With Ti. Cad-cam Framework
Italy56 participantsStarted 2013-12
Plain-language summary
The primary objective of the present study is to evaluate the marginal bone level changes occurring in total edentulous patients treated with six or four implants.
Secondary objective
* overall survival rate
* soft tissue status by assessment of bleeding on probing (BoP) and probing pocket depth (PPD) at baseline and after 1,3,5 years
* prosthetic survival rates including screw or abutment loosening, framework or veneer fractures
Who can participate
Age range
18 Years – 90 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
. age \> 18 years;
. edentulous maxilla or having hopeless remaining teeth that are intended to be extracted;
. willingness to comply with all study requirements and to sign the IC;
. have sufficient amount of bone (8mm or more) in the recipient site to allow implant placement without bone augmentation procedures.
Exclusion criteria
. bone defects associated with severe knife-edge ridges;
. bone defects resulting from tumor resection;
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 resorption in millimeter from the the implant to the bone crest.
Timeframe: 1 year
2
Marginal bone resorption in millimeter from the the implant to the bone crest.
Timeframe: 3 year
3
Marginal bone resorption in millimeter from the the implant to the bone crest.