NCT06018701

A Clinical Trial of Dental Device Cemented with Polymethyl Methacrylate (PMMA) Bone Cement

A Clinical Trial of Dental Device Made of Zirconia Cemented with PMMA Bone Cement on Partial Edentulous Patients of Kathmandu

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Bluebird International Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

Conventional bridge and dental implants have been playing a significant role in replacing missing tooth/teeth. But they come with shortcomings. Hence, to explore the possibility of addressing such shortcomings, a clinical trial study of a new dental device made of zirconia is intended to be studied to see if it could serve as an additional option for fixed prosthodontics. An approach to explore possibilities for cheaper and faster procedure with regards to the treatment of tooth/teeth loss.

Detailed description

Objectives: To determine whether the use of a new dental device made of zirconia cemented with Polymethyl methacrylate (PMMA) bone cement could be an additional option for a faster treatment for missing tooth/teeth with fixed/removable prosthodontics. Methodology: After a Cone Beam Computed Tomography (CBCT) scan and clinical evaluation, 48 samples of zirconia dental device will be cemented with PMMA bone cement in edentulous area on randomized population. Immediate loading (0-15 days) with single crown and multiple unit bridge made of zirconia will be cemented using luting cement as fixed restoration. Radiographic evaluation and clinical examination will be conducted every three (3) months for one year. Expected Outcome: A new dental device made of zirconia could be an additional option for the treatment of edentulism, which could be completed within 0-15 days with minimal risk.

Conditions

• Edentulism

Interventions

Type	Name	Description
DEVICE	A dental device made of zirconia. This is a new invention and does not exist generically. The given generic name of the invention (dental device) is "Dantya Nikhan".	Dental device is surgically placed and cemented with PMMA bone cement on edentulous region.

Timeline

• Start date: 2024-09-03
• Primary completion: 2026-03-15
• Completion: 2026-03-15
• First posted: 2023-08-31
• Last updated: 2025-02-14

Locations

1 site across 1 country: Nepal