Other Unsatisfactory Restoration of ToothPhase 3NCT01359475
A Clinical Trial of an Acetal Resin Crown for Restoration of Primary Molars
A Phase 3 study testing Acetal crown, LD Caulk ltd, USA in people with Other Unsatisfactory Restoration of Tooth, run by Uri Zilberman at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Other Unsatisfactory Restoration of Tooth
- What is being tested?
- Acetal crown, LD Caulk ltd, USA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2010to Jul 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Medically compromising condition
- Informed consent not given
- Teeth with proximal space closures of sufficient magnitude to preclude placement of a test crown
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 3- Clinical Trial on Children. PROTOCOL 465-549
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.
Read more
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.
Read the 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.
- Being tested
- Acetal crown, LD Caulk ltd, USA
- Keywords
- Acetal crowns, Primary molars, The retention of acetal crowns in primary dentition, Color changes of acetal crowns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetal crown, LD Caulk ltd, USAProcedure or surgery
Also called Prefabricated crowns for primary molars
Experimental trial of preformed acetal crowns for primary molars
| Study group | Role | What they receive |
|---|---|---|
| Acetal crown | Experimental | Clinical performance of acetal crowns for treatment of primary molars Receives: Procedure: Acetal crown, LD Caulk ltd, USA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention of acetal crowns for primary molars
Number of patients with adverse events
Measured: two years
Secondary outcomes (1)
Color stability of acetal crown
Change from baseline color of acetal crowns
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2011 (estimated)
- Study startApr 2010
- Primary completionDec 2011
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Other Unsatisfactory Restoration of ToothStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uri Zilberman
- Sponsor type
- University, hospital or other
- Collaborators
- Uri Zilberman
- Responsible party
- Sponsor-investigator, Uri Zilberman, Barzilai Medical Center
- Investigators
- Uri L Zilberman, DMD, PhD, Principal investigator, Barzilai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01359475
- Sponsor's protocol ID
- BMC1505CTIL
- Other IDs
- PROTOCOL 465-549
- Status last verified
- Jul 2020
- First submitted
- 15 May 2011
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3- Clinical Trial on Children. PROTOCOL 465-549
- ClinicalTrials.gov ID
- NCT01359475
- Acronym / sponsor ID
- BMC1505CTIL
- Keywords
- Acetal crowns, Primary molars, The retention of acetal crowns in primary dentition, Color changes of acetal crowns
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Uri ZilbermanUniversity, hospital or other
- Collaborators
- Uri Zilberman
- Study start
- Apr 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 24 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acetal crown | Experimental | Procedure: Acetal crown, LD Caulk ltd, USAClinical performance of acetal crowns for treatment of primary molars |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Medically compromising condition
- Informed consent not given
- Teeth with proximal space closures of sufficient magnitude to preclude placement of a test crown
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetal crown, LD Caulk ltd, USAAlso: Prefabricated crowns for primary molarsExperimental trial of preformed acetal crowns for primary molars | Procedure or surgery | Acetal crown |
Primary outcome
Retention of acetal crowns for primary molars
Time frame: two years
Number of patients with adverse events
1 secondary outcome
Color stability of acetal crown
Time frame: two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Uri L Zilberman, DMD, PhD principal investigator
Barzilai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acetal crown, LD Caulk ltd, USA in people with Other Unsatisfactory Restoration of Tooth, run by Uri Zilberman at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention of acetal crowns for primary molars (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2020.