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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-03

Study Completion Date

2026-03-15

Brief Summary

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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.

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Detailed Description

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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

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Edentulism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Total forty eight (48) dental devices made of zirconia will be cemented. 12 dental device in each allocated quadrant, i.e., maxillary anterior, maxillary posterior, mandibular anterior and mandibular posterior. And the results will be compared.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Maxillary Anterior

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

Group Type EXPERIMENTAL