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

Phase 3

Completed

• Conditions: Other Unsatisfactory Restoration of Tooth
• Interventions: Procedure: Acetal crown, LD Caulk ltd, USA

• Registration Number: NCT01359475
• Lead Sponsor: Uri Zilberman

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.

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2011-05-15
• Study First Submitted QC: 2011-05-23
• Study First Posted: 2011-05-24
• Primary Completion: 2011-12
• Study Completion: 2013-07
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-12
• Last Update Posted: 2020-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acetal crown	Acetal crown, LD Caulk ltd, USA	Clinical performance of acetal crowns for treatment of primary molars

Primary Outcome Measures

Name	Time	Method
Retention of acetal crowns for primary molars	two years	Number of patients with adverse events

Secondary Outcome Measures

Name	Time	Method
Color stability of acetal crown	two years	Change from baseline color of acetal crowns

Trial Locations

Locations (1)

Pediatric Dental Clinic, BarzilaiMC; 🇮🇱 Ashkelon, Israel