Pediatric Dental Clinic, BarzilaiMC
Ashkelon, 78278, Israel
Completed
NCT Number: NCT01359475
A Clinical Trial of an Acetal Resin Crown for Restoration of Primary Molars
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.
Completed
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Notify MeKey information
Conditions
Age range
4 year–8 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Acetal crown, LD Caulk ltd, USA
ProcedureExperimental trial of preformed acetal crowns for primary molars
Other names: Prefabricated crowns for primary molars
Primary outcomes
-
Retention of acetal crowns for primary molars
Time frame: two years
Number of patients with adverse events
Secondary outcomes
-
Color stability of acetal crown
Time frame: two years
Change from baseline color of acetal crowns
Sponsors and collaborators
Lead sponsor
Uri Zilberman
Other
Collaborators
- Uri Zilberman
Registry information
Official study title
Phase 3- Clinical Trial on Children. PROTOCOL 465-549
Important dates
- Study start
- 2010
- Primary completion
- 2011
- Study completion
- 2013
- First posted
- May 24, 2011
- Registry last updated
- Jul 14, 2020
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.