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

NCT ID: NCT01359475

Last Updated: 2020-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2013-07-31

Brief Summary

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.

Detailed 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.

Conditions

Other Unsatisfactory Restoration of Tooth

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Acetal crown

Clinical performance of acetal crowns for treatment of primary molars

Group Type: EXPERIMENTAL

Acetal crown, LD Caulk ltd, USA

Intervention Type: PROCEDURE

Experimental trial of preformed acetal crowns for primary molars

Interventions

Acetal crown, LD Caulk ltd, USA

Experimental trial of preformed acetal crowns for primary molars

Intervention Type: PROCEDURE

Other Intervention Names

Prefabricated crowns for primary molars

Eligibility Criteria

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Uri Zilberman

UNKNOWN

Sponsor Role: collaborator

Uri Zilberman

OTHER

Sponsor Role: lead

Responsible Party

Uri Zilberman

Head of Dentistry Unit

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Uri L Zilberman, DMD, PhD

Role: PRINCIPAL_INVESTIGATOR

Barzilai Medical Center

Locations

Pediatric Dental Clinic, BarzilaiMC

Ashkelon, , Israel

Countries

Israel

Other Identifiers

PROTOCOL 465-549

Identifier Type: OTHER

Identifier Source: secondary_id

BMC1505CTIL

Identifier Type: -

Identifier Source: org_study_id