We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01359475
Recruitment Status : Completed
First Posted : May 24, 2011
Last Update Posted : July 3, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.


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

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 3- Clinical Trial on Children. PROTOCOL 465-549
Study Start Date : April 2010
Primary Completion Date : December 2011
Study Completion Date : July 2013
Arms and Interventions

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 Name: Prefabricated crowns for primary molars


Outcome Measures

Primary Outcome Measures :
  1. Retention of acetal crowns for primary molars [ Time Frame: two years ]
    Number of patients with adverse events


Secondary Outcome Measures :
  1. Color stability of acetal crown [ Time Frame: two years ]
    Change from baseline color of acetal crowns


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   4 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01359475


Locations
Israel
Pediatric Dental Clinic, BarzilaiMC
Ashkelon, Israel, 78278
Sponsors and Collaborators
Ornit Cohen
Uri Zilberman
Investigators
Principal Investigator: Uri L Zilberman, DMD, PhD Barzilai Medical Center
More Information

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 ( Other Identifier: LD Caulk, Usa )
First Posted: May 24, 2011    Key Record Dates
Last Update Posted: July 3, 2013
Last Verified: July 2013

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