Guided placement of zygomatic implants for maxilla reconstruction
Evaluation of Computer Guided Placement of Zygomatic Implants for Reconstruction of Atrophic Maxilla Utilizing Two Different Approaches: A Randomized Controlled Clinical Trial
This study tests which of two surgical methods for placing zygomatic implants helps people with severe bone loss in their upper jaw recover better and have fewer complications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 11 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06129695 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of computer-guided placement of zygomatic implants using two different surgical approaches: intra sinus and extra sinus. It aims to determine which method results in fewer postoperative complications for patients with severely atrophic maxillae. The study focuses on patients who cannot be treated with conventional implants due to significant bone loss. By comparing these two techniques, the research seeks to improve rehabilitation outcomes for edentulous patients.
Who should consider this trial
Good fit: Ideal candidates are patients with severely atrophic edentulous upper arches who cannot be restored by other treatments and have sufficient anterior maxilla bone height.
Not a fit: Patients with systemic diseases that prevent surgical procedures, uncontrolled diabetes, or those with significant smoking habits may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical techniques for zygomatic implant placement, enhancing patient satisfaction and outcomes.
How similar studies have performed: Previous studies have shown promising results with zygomatic implants, but this specific comparison of intra and extra sinus approaches is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with severely atrophic edentulous upper arch (Cawood class IV, V, VI) that could not be restored by other type of treatment 2. Patients who had at least 8-12 mm vertical bone height in anterior maxilla to allow installation of 2 conventional implants. 3. Lacking posterior maxillary bone support due to significant sinus pneumatistion 4. Good systemic health (ASA score I-II) 5. Highly motivated patients. Exclusion Criteria: 1. Patient not willing to give his/her informed consent. 2. Patients with systemic disease that did not permit the surgical procedure (including general anaesthesia). 3. Patients with uncontrolled diabetes or under bisphosphonate therapy. 4. Heavy smoker.(\> 20 cigarettes daily) 5. Patient with psychiatric problems, severe bruxism or other parafunctional habits. 6. Acute sinusitis. 7. Malignancy or pathology in Maxilla or Zygoma.
Where this trial is running
Cairo
- Faculty of Dentistry, Cairo University — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Abdulrahman Adnan Aldakka, B.D.S
- Email: abdulrahman.adnan@dentistry.cu.edu.eg
- Phone: 00201026451243
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.