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

Phase 3- Clinical Trial on Children. PROTOCOL 465-549

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.

Study Overview

• Status: Completed
• Conditions: Other Unsatisfactory Restoration of Tooth
• Intervention / Treatment: Procedure: Acetal crown, LD Caulk ltd, USA

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 Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 3

Contacts and Locations

Study Locations

• Israel
  • Ashkelon, Israel, 78278
    • Pediatric Dental Clinic, BarzilaiMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 8 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acetal crown; Clinical performance of acetal crowns for treatment of primary molars	Procedure: Acetal crown, LD Caulk ltd, USA; Experimental trial of preformed acetal crowns for primary molars; Other Names: Prefabricated crowns for primary molars

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention of acetal crowns for primary molars	Number of patients with adverse events	two years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Color stability of acetal crown	Change from baseline color of acetal crowns	two years

Collaborators and Investigators

• Sponsor: Uri Zilberman
• Collaborators: Uri Zilberman
• Investigators: Principal Investigator: Uri L Zilberman, DMD, PhD, Barzilai Medical Center

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: May 15, 2011
• First Submitted That Met QC Criteria: May 23, 2011
• First Posted (Estimate): May 24, 2011

Study Record Updates

• Last Update Posted (Actual): July 14, 2020
• Last Update Submitted That Met QC Criteria: July 12, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Primary molars; Acetal crowns; The retention of acetal crowns in primary dentition; Color changes of acetal crowns
• Other Study ID Numbers: BMC1505CTIL; PROTOCOL 465-549 (Other Identifier: LD Caulk, Usa)