Polyoxymethylene (POM) in the Production of Telescopic Denture in Older Adults With Subtotal Edentulism

Summary

The mail goal of this study is to evaluate the success of the prosthetic treatment with telescopic removable partial denture with framework made of polyoxymethylene (POM). In accordance with the growing older population, who often require complex dental care, it is very important to test simple yet effective and safe solutions. Bearing in mind that POM has proven to be a good solution for conventional removable partial dentures with clasps (RPD), and that it is quite common to have 2-3 remaining teeth, a denture with a framework made of light and flexible material such as POM present a good solution. The hypothesis is that a POM telescopic denture is clinically as adequate, effective and safe as the conventional complex cobalt chromium molybdenum alloy denture with clasps. Telescopic denture should provide better comfort and longevity compared to conventional RPD because of axial loading of the abutment teeth and no negative biological effect of clasps. Moreover, conventional telescopic denture is made of precious alloys which increase their cost; therefore, POM telescopic denture present great advantage in cost/effective treatment. Telescopic crowns are comprised of inner and outer crowns; accordingly, telescopic denture represent a type of complex denture where one part is fixed on the remaining teeth (inner crowns) and other part (outer crowns and denture framework) is removable.

The key factors that will define the success of the treatment will be: assessment of dentures' retention, oral health related quality of life, presence of biological complications, presence of mechanical complications, denture appearance and chewing function assessment.

Conditions

• Subtotal Edentulism

Interventions

DEVICE

Production of polyoxymethylene telescopic denture

Remaining teeth will be prepared by conventional grinding technique, followed by impression, casting and scanning with extra oral scanner. Inner telescopic crowns will be made of cobalt-chromium alloy by milling technique and outer crowns together with denture framework will be made of polyoxymethylene by the method of single phase injection moulding. Denture delivery is done by inserting both inner and outer crown at the same time, during which the inner crown is cemented to the abutment tooth and the contact surfaces of the outer and inner crown are isolated so that the outer crown and denture framework can be removed.

DEVICE

Production of conventional complex partial denture with clasps

A conventional complex partial denture is a removable partial denture with clasps combined with metal-ceramic surveyed crowns with milled surfaces for removable dentures. The metal-ceramic surveyed crowns are shaped in such a way that they build a morphological and functional whole with complementary elements of the removable partial denture's framework. In the control group, as well as in the experimental group, the remaining teeth are prepared using a conventional grinding technique, then an impression is taken for dedicated metal-ceramic crowns, casting, and milling of crowns, ceramic sintering, impression through the metal-ceramic surveyed crowns and fabrication of a removable partial denture's framework with clasps using the casting method. Dedicated fixed restorations will be made of Co-Cr alloy inside the crown and ceramic layer on the surface, and the framework and clasps of the removable partial denture will be made of Co-Cr-Mo alloy.

Sponsors & Collaborators

• University of Belgrade

  lead OTHER

Principal Investigators

• Aleksandra Popovac · School of Dental Medicine, University of Belgrade

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

65 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-01-30

Primary Completion

2024-12-30

Completion

2027-01-31

FDA Device

Yes

Countries

• Serbia

Study Locations