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NCT01359475
Phase 3- Clinical Trial on Children. PROTOCOL 465-549
Phase 3 trial testing Acetal crown, LD Caulk ltd, USA in Other Unsatisfactory Restoration of Tooth in 52 participants. Completed in 1 July 2013.
1 December 2011
Quick facts
| Lead sponsor | Uri Zilberman |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 52 |
| Start date | 1 April 2010 |
| Primary completion | 1 December 2011 |
| Estimated completion | 1 July 2013 |
| Sites | 1 location across Israel |
Drugs / interventions tested
- Acetal crown, LD Caulk ltd, USA
Conditions studied
- Other Unsatisfactory Restoration of Tooth — all drugs for Other Unsatisfactory Restoration of Tooth →
Sponsor
Uri Zilberman
Who can join
Adults 4 to 8, any sex, with Other Unsatisfactory Restoration of Tooth. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Retention of acetal crowns for primary molars
Time frame: two years
Number of patients with adverse events
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01359475
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Related trials
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01359475 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Uri Zilberman
- Last refreshed: 12 July 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01359475.
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