A Clinical Trial of an Acetal Resin Crown for Restoration... | NCT01359475

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

NCT01359475

Sponsor

Uri Zilberman

Status

Completed

Last Update Posted

Jul 14, 2020Actual

Enrollment

52Actual

Phase

Phase 3

Conditions

Other Unsatisfactory Restoration of Tooth

Interventions

Acetal crown, LD Caulk ltd, USA

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
PROTOCOL 465-549	Other Identifier	LD Caulk, Usa

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2010

Primary Completion Date

Dec 2011Actual

Completion Date

Jul 2013Actual

First Submitted Date

May 15, 2011

First Submission Date that Met QC Criteria

May 23, 2011

First Posted Date

May 24, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 12, 2020

Last Update Posted Date

Jul 14, 2020Actual

Name	Class
Uri Zilberman	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

52Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Acetal crown	Experimental	Clinical performance of acetal crowns for treatment of primary molars	Procedure: Acetal crown, LD Caulk ltd, USA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Acetal crown, LD Caulk ltd, USA	Procedure	Experimental trial of preformed acetal crowns for primary molars	Acetal crown

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Retention of acetal crowns for primary molars	Number of patients with adverse events	two years

Secondary Outcomes

Measure	Description	Time Frame
Color stability of acetal crown	Change from baseline color of acetal crowns	two years

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

8 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Uri L Zilberman, DMD, PhD	Barzilai Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pediatric Dental Clinic, BarzilaiMC		Ashkelon		78278	Israel