A Clinical Trial of an Acetal Resin Crown for Restoration of Primary Molars
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|ClinicalTrials.gov Identifier: NCT01359475|
Recruitment Status : Completed
First Posted : May 24, 2011
Last Update Posted : July 3, 2013
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.
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|
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 (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 3- Clinical Trial on Children. PROTOCOL 465-549|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||July 2013|
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
- Retention of acetal crowns for primary molars [ Time Frame: two years ]Number of patients with adverse events
- Color stability of acetal crown [ Time Frame: two years ]Change from baseline color of acetal crowns
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
|Pediatric Dental Clinic, BarzilaiMC|
|Ashkelon, Israel, 78278|
|Principal Investigator:||Uri L Zilberman, DMD, PhD||Barzilai Medical Center|