New dental device for replacing missing teeth
A Clinical Trial of Dental Device Made of Zirconia Cemented with PMMA Bone Cement on Partial Edentulous Patients of Kathmandu
This study is testing a new dental device made of zirconia to see if it can quickly and affordably help people with missing teeth.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Bluebird International Clinic Academic / other |
| Locations | 1 site (Kathmandu, Bagmati) |
| Trial ID | NCT06018701 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates a new dental device made of zirconia, cemented with Polymethyl Methacrylate (PMMA) bone cement, as a potential solution for edentulism. The study aims to determine if this device can provide a faster and more cost-effective treatment option for patients with missing teeth. Participants will undergo a Cone Beam Computed Tomography (CBCT) scan and clinical evaluation before receiving the device, which will be loaded immediately after placement. The effectiveness and safety of the device will be monitored through radiographic evaluations and clinical examinations over a year.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and above with single or multiple missing teeth and adequate bone density.
Not a fit: Patients with severe medical conditions or those over 80 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could offer patients a quicker and more affordable solution for tooth replacement.
How similar studies have performed: While conventional methods for tooth replacement are well-established, this specific approach using zirconia and PMMA is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients (18 years old and above) who agrees for the treatment * Single/multiple missing tooth/teeth (edentulism) * Maxillary/mandibular bone density of more than 350 Hounsfield Unit (HU) * Edentulous region with minimum of 2mm bone width and 5mm of bone height * Well controlled diabetes and hypertension Exclusion Criteria: * Severe/Critical medical conditions * Adults above 80 years old
Where this trial is running
Kathmandu, Bagmati
- Bluebird International Clinic — Kathmandu, Bagmati, Nepal (Recruiting)
Study contacts
- Study coordinator: Parakram Parajuli, DMD
- Email: parakramp@hotmail.com
- Phone: +9779851250250
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.