Other Unsatisfactory Restoration of Tooth
Conditions
Keywords
Acetal crowns, Primary molars, The retention of acetal crowns in primary dentition, Color changes of acetal crowns
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.
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.
Interventions
PROCEDUREAcetal crown, LD Caulk ltd, USA
Experimental trial of preformed acetal crowns for primary molars
Sponsors
Uri Zilberman
Uri Zilberman
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 8 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention of acetal crowns for primary molars | two years | Number of patients with adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Color stability of acetal crown | two years | Change from baseline color of acetal crowns |
Countries
Israel
Outcome results
None listed