Clinical trial NCT01359475: A Clinical Trial of an Acetal Resin Crown for Restoration of Primary Molars
Official title: Phase 3- Clinical Trial on Children. PROTOCOL 465-549
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Other Unsatisfactory Restoration of Tooth
Keywords: Acetal crowns
Primary molars
The retention of acetal crowns in primary dentition
Color changes of acetal crowns
Lead sponsor: Barzilai Medical Center
Sponsor class: OTHER
Collaborators: name: Uri Zilberman
First posted: 2011-05-24
Enrollment: 52
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Retention of acetal crowns for primary molars
timeFrame: two years
Secondary outcomes:
measure: Color stability of acetal crown
timeFrame: two years
Other outcomes:
Locations:
city: Ashkelon
country: Israel
facility: Pediatric Dental Clinic, BarzilaiMC
Study officials:
affiliation: Barzilai Medical Center
name: Uri L Zilberman, DMD, PhD
role: PRINCIPAL_INVESTIGATOR
References: