Comparing bone gain using 3D printed zirconia barriers and titanium mesh
Clinical and Radiographic Evaluation of Bone Gain Using Customized 3D Printed Zirconia Barrier Versus Titanium Mesh in Combined Ridge Defects in The Aesthetic Zone: A Randomized Clinical Trial
This study is testing whether 3D printed zirconia barriers can help people with bone defects in their mouths gain more bone than traditional titanium mesh.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 26 (estimated) |
| Ages | 20 Years to 70 Years |
| Sex | All |
| Sponsor | Cairo University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06559605 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of customized 3D printed zirconia barriers compared to traditional titanium mesh in promoting bone gain in patients with combined ridge defects in the esthetic zone. The study involves a randomized design with 26 sites, where patients will be assigned to receive either the zirconia barrier or titanium mesh after thorough pre-operative assessments. The primary outcome is the amount of bone gained, measured both clinically and radiographically, following the procedure. The trial aims to address the complications associated with titanium mesh while exploring the potential benefits of zirconia in bone augmentation.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20-70 with specific bone loss characteristics and good oral hygiene.
Not a fit: Patients with pathological lesions, uncontrolled systemic diseases, or poor oral hygiene may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective and less complication-prone method for bone augmentation in dental procedures.
How similar studies have performed: While the use of titanium mesh is well-established, the application of customized 3D printed zirconia barriers is a novel approach that has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age: 20-70 years. * Bone width less than 4mm * Vertical bone height less than 9mm * Periodontally sound neighboring teeth * Patients with sound vertical occlusal bite dimension * Good oral hygiene (full mouth plaque control record \[PCR\] \< 25%,full mouth bleeding on probing (BOP) \< 25% . * Patients demonstrating understanding and commitment to the post-operative care regime and the study follow up timeline. * Good general health (including participants with well-controlled systemic disease) Exclusion Criteria: 1. Pathological lesions (abscess-cyst-acute infection) in the defect site 2. Systemic diseases that would interfere with bone metabolism 3. Uncontrolled diabetic patients 4. Ongoing treatment or a history of recent chemotherapy or radiotherapy 5. Poor oral hygiene after hygienic phase (Plaque control record over 30%) or Active periodontal disease
Where this trial is running
Cairo
- Cairo university — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Amaal Abdalnassar abdalzeim
- Email: amaalabdalnassar@gmail.com
- Phone: 01003752752
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.