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

Other Unsatisfactory Restoration of Tooth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01359475
• Other study ID #: BMC1505CTIL
• Secondary ID: PROTOCOL 465-549
• Status: Completed
• Phase: Phase 3
• Start date: April 2010
• Est. completion date: July 2013

Study information

• Verified date: July 2020
• Source: Barzilai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: July 2013
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Other Unsatisfactory Restoration of Tooth

Intervention

Procedure:
• Acetal crown, LD Caulk ltd, USA
Experimental trial of preformed acetal crowns for primary molars

Locations

Country	Name	City	State
Israel	Pediatric Dental Clinic, BarzilaiMC	Ashkelon

Sponsors (2)

Lead Sponsor	Collaborator
Uri Zilberman	Uri Zilberman

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention of acetal crowns for primary molars	Number of patients with adverse events	two years
Secondary	Color stability of acetal crown	Change from baseline color of acetal crowns	two years