Dynamic Navigation for Zygomatic Implant Rehabilitation Using an Intraoral Reference System: Eval… (NCT07124715) | Clinical Trial Compass
CompletedNot Applicable
Dynamic Navigation for Zygomatic Implant Rehabilitation Using an Intraoral Reference System: Evaluation of a New Zygomatic Implant Design
22 participantsStarted 2017-01
Plain-language summary
This clinical study aims to evaluate the effectiveness and safety of zygomatic implants placed using dynamic navigation technology. Specifically, it compares two types of zygomatic implants with different surface characteristics: one with a fully rough surface and another with a partially smooth (machined) surface near the gum line. The goal is to determine whether surface design affects surgical performance, healing, implant success, and patient outcomes. A total of 22 patients with severe upper jaw bone loss will receive both types of implants-one on each side of the upper jaw-in a randomized, split-mouth design. The study also evaluates pain, swelling, healing time, and patient quality of life over a 5-year follow-up period.
Who can participate
Age range
18 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:
Patients requiring partial or full rehabilitation of the atrophic maxilla
Candidates for placement of at least one zygomatic implant per side (right and left), connected to at least one standard or zygomatic implant
Severe maxillary atrophy confirmed by CT scan, with insufficient bone for conventional implants or only sufficient bone for 2 frontal implants (minimum diameter 3.5 mm, length 8 mm)
Residual alveolar crest height ≤ 4 mm beneath the maxillary sinus
Age ≥ 18 years
Signed informed consent
Exclusion Criteria:
General contraindications to oral surgery
History of radiation therapy to the head and neck exceeding 70 Gy
Compromised or suppressed immune system
Current or past use of intravenous bisphosphonates
Uncontrolled diabetes mellitus
Alcohol or drug dependency
Psychiatric disorders
Pregnancy or breastfeeding
Participation in other clinical trials
Inability to attend a 5-year follow-up
Limited mouth opening (\< 3.5 cm interincisal distance)
Absence of opposing dentition or lower prosthesis
Acute or chronic infection in the intended implant site
Untreated active periodontal disease
Poor oral hygiene motivation
Radiographic signs of sinus membrane inflammation or ostium obstruction
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.