A Clinical Trial of an Acetal Resin Crown for Restoration of Primary Molars

Uri Zilberman

Status and phase

Completed

Phase 3

Conditions

Other Unsatisfactory Restoration of Tooth

Treatments

Procedure: Acetal crown, LD Caulk ltd, USA

Study type

Interventional

Funder types

Other

Identifiers

NCT01359475

PROTOCOL 465-549 (Other Identifier)

BMC1505CTIL

Details and patient eligibility

About

Preformed stainless steel crowns have been used in Pediatric Dentistry to restore badly broken down primary teeth since 1950. They are generally considered more expedient to place than large multi-surface amalgam or composite restorations and have a longer life. They have been used successfully in clinical practice for many years and have presented little in the way of adverse events. The major drawback is the poor esthetics along with lingering concerns over potential health hazards associated with the nickel content. Several attempts have been made to improve upon the esthetics of stainless steel crowns such as veneering the buccal and occlusal surfaces and substituting composite resin for the entire crown, but to date none of these approaches have been very successful.

Acetal resin has been used in a number of applications in medicine and dentistry, and recently has met with early success when tested as a substitute for stainless steel crowns. It has a number of excellent physical and mechanical properties including a low coefficient of friction, good wear resistance, high fatigue resistance, good impact strength and resistance to creep.

The purpose of this trial is to compare the clinical performance of preformed acetal resin crowns and preformed stainless steel crowns.

2.0 OBJECTIVES

The objective of this study is to compare the clinical performance of acetal resin crowns with preformed stainless steel crowns when used to restore primary molar teeth.

Full description

STUDY POPULATION

A minimum of 25 subjects contributing a minimum of 40 acetal crowns ( on primary molar teeth will be recruited from the patient pool of the pediatric dentistry clinic at Barzilai Medical Center, Ashkelon and enrolled into the study. A maximum of four crowns will be placed in any subject. It is estimated that it will take approximately 14 weeks to place all crowns and complete the baseline examination.

Enrollment

52 patients

Sex

All

Ages

4 to 8 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Patients of record at the pediatric dentistry clinic at Barzilai Medical Center, Ashkelon
Ages 3-8 (inclusive)
In need of at least one Stainless Steel Crown on either a first or second primary molar

Exclusion criteria

Medically compromising condition
Informed consent not given
Teeth with proximal space closures of sufficient magnitude to preclude placement of a test crown