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

Bluebird International Clinic

Status and phase: Enrolling; Early Phase 1

Conditions: Edentulism

Treatments: 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".

Study type: Interventional

Funder types: Other

Identifiers

NCT06018701

BluebirdIC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 4 patient groups

Maxillary Anterior

Experimental group

Description:

Dental device will be cemented with PMMA bone cement on group that have missing tooth on maxillary anterior region.

Treatment:

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".

Maxillary Posterior

Experimental group

Description:

Dental device will be cemented with PMMA bone cement on group that have missing tooth on maxillary posterior region.

Treatment:

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".

Mandibular Anterior

Experimental group

Description:

Dental device will be cemented with PMMA bone cement on group that have missing tooth on mandibular anterior region.

Treatment:

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".

Mandibular Posterior

Experimental group

Description:

Dental device will be cemented with PMMA bone cement on group that have missing tooth on mandibular posterior region.

Treatment:

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".