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

This study has been completed.
Sponsor:
Collaborator:
Uri Zilberman
Information provided by (Responsible Party):
Ornit Cohen, Barzilai Medical Center
ClinicalTrials.gov Identifier:
NCT01359475
First received: May 15, 2011
Last updated: July 2, 2013
Last verified: July 2013

May 15, 2011
July 2, 2013
April 2010
December 2011   (final data collection date for primary outcome measure)
Retention of acetal crowns for primary molars [ Time Frame: two years ] [ Designated as safety issue: No ]
Number of patients with adverse events
Same as current
Complete list of historical versions of study NCT01359475 on ClinicalTrials.gov Archive Site
Color stability of acetal crown [ Time Frame: two years ] [ Designated as safety issue: No ]
Change from baseline color of acetal crowns
Same as current
Not Provided
Not Provided
 
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 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.

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Other Unsatisfactory Restoration of Tooth
Procedure: Acetal crown, LD Caulk ltd, USA
Experimental trial of preformed acetal crowns for primary molars
Other Name: Prefabricated crowns for primary molars
Experimental: Acetal crown
Clinical performance of acetal crowns for treatment of primary molars
Intervention: Procedure: Acetal crown, LD Caulk ltd, USA
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
July 2013
December 2011   (final data collection date for primary outcome measure)

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
Both
4 Years to 8 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01359475
BMC1505CTIL, PROTOCOL 465-549
No
Ornit Cohen, Barzilai Medical Center
Ornit Cohen
Uri Zilberman
Principal Investigator: Uri L Zilberman, DMD, PhD Barzilai Medical Center
Barzilai Medical Center
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP