Evaluation of bone after maxillary sinus augmentation using different materials
Histomorphometric and Radiographic Assessment of Bone Following Maxillary Sinus Augmentation Using Bone Marrow Concentrate Cells From the Maxillary Tuberosity Mixed With Bovine Bone Versus Autogenous Bone Mixed With Bovine Bone: RCT
PHASE1 · Cairo University · NCT06700772
This study tests if using a special mixture of bone and bone marrow can help improve bone quality for dental implants in patients with a sinus issue.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 26 (estimated) |
| Ages | 20 Years to 50 Years |
| Sex | All |
| Sponsor | Cairo University (other) |
| Locations | 2 sites (Cairo, New Cairo and 1 other locations) |
| Trial ID | NCT06700772 on ClinicalTrials.gov |
What this trial studies
This clinical trial involves two groups of patients with a deficient maxillary alveolar ridge and a pneumatized sinus who require dental implants. One group will undergo open sinus lifting using autogenous bone mixed with bone marrow aspirate concentrate from the maxillary tuberosity, while the other group will receive a mixture of autogenous bone and bovine bone. The procedure will be performed under local anesthesia, and patients will be monitored for six months post-operation to evaluate bone regeneration and implant success. The study aims to determine the effectiveness of using bone marrow aspirate concentrate in enhancing bone quality for dental implants.
Who should consider this trial
Good fit: Ideal candidates are patients with missing maxillary teeth, a pneumatized sinus, and remaining bone height of less than 5mm.
Not a fit: Patients who smoke, are pregnant, or have medical conditions that contraindicate surgical procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve bone regeneration and increase the success rate of dental implants in patients with maxillary deficiencies.
How similar studies have performed: While similar studies have explored various augmentation techniques, the specific combination of bone marrow aspirate concentrate and bovine bone in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with missing maxillary teeth with pneumatized sinus and remaining bone height \<5mm 2. Patients with healthy systemic condition (Medically free) 3. Adequate inter-arch space for placement of the implant prosthetic part. 4. Good oral hygiene 5. Cooperative patients who are willing to commit for 6 months follow up Exclusion Criteria: 1. Smokers 2. Pregnant females 3. Patient with medical condition that contraindicates surgical procedures. 4. Patients on medication that may interfere with healing (corticosteroids, bisphosphonate, Chemo/radio therapy). 5. Patients with habits that may jeopardize the implant longevity and affect the results of the study such as alcoholism or parafunctional habits. 6. Patients have chronic sinus disease.
Where this trial is running
Cairo, New Cairo and 1 other locations
- Faculty of oral and dental medicine - cairo university — Cairo, New Cairo, Egypt (RECRUITING)
- Faculty of oral and dental medicine - cairo university — Cairo, Egypt (RECRUITING)
Study contacts
- Study coordinator: Alaa Hassan, BSc
- Email: Alaa.abdullah@dentistry.cu.edu.eg
- Phone: 01026980299
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.
Conditions: Sinus Floor Elevation, Bone replacement materials, Bone substitutes, Maxillary sinus augmentation