Comparison of Extra-short (4 mm) Implants Used as Distal Support of a Maxillary Full-arch Fixed D… (NCT03958448) | Clinical Trial Compass
CompletedNot Applicable
Comparison of Extra-short (4 mm) Implants Used as Distal Support of a Maxillary Full-arch Fixed Dental Prosthesis vs. 10 mm Implants Installed After Sinus Floor Elevation.
20 participantsStarted 2015-10-01
Plain-language summary
Recently, 4 mm long implants with a standard diameter have been used for the restoration of the posterior edentulous mandible with favorable results. However, randomized clinical trials reporting the results from full-arch fixed dental prosthesis that included 4 mm long implants placed in the posterior regions of the maxilla have not been published yet. The aim of the present study will be to compare the survival and success rates of 4 mm implants used as distal support of a maxillary full-arch fixed dental prosthesis with standard (10 mm) implants placed in association with a bilateral sinus floor augmentation procedure
Who can participate
Age range
18 Years – 75 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 maxilla
* Willing to receive a full arch fixed restoration in the maxilla.
* Latest extraction at least 8 weeks before implant insertion
* Sinus floor height included between 4 to 6 mm
* Bone width in the distal segments sufficient to allow the insertion of a 4 mm long implant of standard diameter.
* In the anterior maxilla (from first premolar to first premolar) bone width sufficient to allow the insertion of 10 mm long implants of standard diameter. Minor horizontal augmentations with guided bone regeneration procedures was allowed in the anterior maxilla.
the opposing arch have to present one of the following conditions:
* natural dentition (at least 10 elements from 3.5 to 4.5)
* Fixed dental prosthesis of at least 10 elements (from 3.5 to 4.5) supported by teeth or implants
* Implant supported or teeth supported overdentures
* Adequate partial removable prostheses.
Exclusion Criteria:
* Presence of conditions requiring prophylactic use of antibiotics (e.g., history of rheumatic heart disease, bacterial endocarditis, cardiac valvular anomalies, prosthetic joint replacements).
* Major systemic diseases, or medical conditions requiring prolonged use of steroids, or alcoholism or chronically drug abuse.
* Current pregnancy or breastfeeding women
* Smokers \> 10 cigarettes per day
* Physical handicaps that would interfere with the ability to perform adequate oral hygiene
* Immunocompromised patients including patients infected with HIV
* …
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
survival rate of 4 mm implants used as distal support