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

This study is currently recruiting participants.
Verified September 2012 by Barzilai Medical Center
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: September 19, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Other Unsatisfactory Restoration of Tooth
 Procedure: Acetal crown, LD Caulk ltd, USA
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 3- Clinical Trial on Children. PROTOCOL 465-549

Further study details as provided by Barzilai Medical Center:

Primary Outcome Measures:
  • Retention of acetal crowns for primary molars [ Time Frame: two years ] [ Designated as safety issue: No ]
    Number of patients with adverse events


Secondary Outcome Measures:
  • Color stability of acetal crown [ Time Frame: two years ] [ Designated as safety issue: No ]
    Change from baseline color of acetal crowns


Estimated Enrollment: 25
Study Start Date: April 2010
Estimated Study Completion Date: January 2013
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Prefabricated crowns for primary molars

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.

  Eligibility

Ages Eligible for Study:   4 Years to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01359475

Locations
Israel
Pediatric Dental Clinic, BarzilaiMC Recruiting
Ashkelon, Israel, 78278
Contact: Uri L Zilberman, DMD, PhD     +972-8-6745854     ori@barzi.health.gov.il    
Principal Investigator: Uri L Zilberman, DMD, PhD            
Sponsors and Collaborators
Ornit Cohen
Uri Zilberman
Investigators
Principal Investigator: Uri L Zilberman, DMD, PhD Barzilai Medical Center
  More Information

No publications provided

Responsible Party: Ornit Cohen, r&d unit, Barzilai Medical Center
ClinicalTrials.gov Identifier: NCT01359475     History of Changes
Other Study ID Numbers: BMC1505CTIL, PROTOCOL 465-549
Study First Received: May 15, 2011
Last Updated: September 19, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Barzilai Medical Center:
Acetal crowns
Primary molars
The retention of acetal crowns in primary dentition
Color changes of acetal crowns

ClinicalTrials.gov processed this record on May 22, 2013