Wear, ToothzlsNCT04914962
Wear of Enamel Antagonist to ZLS Crowns
A study testing glazed zirconium lithium silicate and polished zirconium lithium silicate in people with Wear, Tooth and Wear, Occlusal, run by Cairo University.
Trial summary
The aim of this study is to evaluate the antagonist enamel wear of two processing options of Celtra duo crowns (polished and glaze fired) restoring posterior teeth in comparison with sound enamel wear at baseline and 6 months Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Wear, Tooth, Wear, Occlusal
- What is being tested?
- glazed zirconium lithium silicate and polished zirconium lithium silicate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- 10 Jul 2021to 1 Jul 2022
- Phase
- Interventional
- 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 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pt aged 21-60 years old, be able to read and sign the informed consent document.
- Psychologically and physically able to withstand conventional dental procedures.
- Patients needing posterior full coverage restorations
- Patients with sound natural antagonists.
- Have no active periodontal or pulpal diseases
- Able to attend punctually for preplanned visits and evaluation.
Who cannot join
- Patients with poor oral hygiene, high caries risk and uncooperative patients.
- Pregnant women.
- Psychiatric problems or unrealistic expectations.
- Lack of opposing dentition in the area of interest.
- Restored occlusal surface opposing the planned restoration.
- The presence of a removable or fixed orthodontic appliance.
- Patients with parafunctional habits.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Wear of Enamel Antagonist to Polished Versus Glazed Zirconia Reinforced Lithium Silicate Crowns (Randomized Clinical Trial)
The aim of this study is to evaluate the antagonist enamel wear of two processing options of Celtra duo crowns (polished and glaze fired) restoring posterior teeth in comparison with sound enamel wear at baseline and 6 months
Read the detailed description
Adhesive dental ceramics have proven to guarantee optimal esthetic results alongside satisfactory mechanical properties. Due to these qualities, today they are considered the first-choice restorative materials both for minimal restorations and for the reconstruction of severely compromised teeth. Gold alloy reconstructions preferred in the past, especially for their optimal wear properties, have been progressively substituted by these new materials.
Loss of hard tooth substance is a natural process taking place during mastication. Also, Increased wear is a common reason of failure for restorations exposed to masticatory forces. Excessive wear may be responsible for numerous problems, such as hypersensitivity, loss of occlusal contact, defects of the periodontium, reduction of masticatory efficiency, tooth migration and wrong tooth relations, weakness of masticatory muscles, and changes in the vertical and horizontal jaw relations, which may cause functional and esthetic impairments.
An optimal restorative material should provide similar characteristics to natural dental tissues. The physiological wear of enamel and dentin should represent the reference for a reasonable wear pattern of restorative materials The manufacturers tend to improve the mechanical behavior of their products leads to the progressive offer of new ceramics for daily practice. Assessment of their wear behavior and comparison through detailed tests become necessary at this point.
comparing the wear of enamel opposing polished zirconia, polished lithium disilicate crowns opposing to natural tooth. Patients were recalled after 1year and impression were recorded with opposing arch and baseline and final cast were scanned and superimposed using 3 D scanner. They found that the mean of occlusal wear of the antagonistic enamel of polished zirconia was 42.0 μm, Enamel wear against natural antagonist (control group) 34.68 μm, whereas, for Enamel wear against polished lithium disilicate crowns (group 2) 40.06 μm Enamel wear against natural antagonist (control group) 35.09 μm.
studying the quality of CAD/CAM fabricated single tooth restorations (Ten zirconia restorations were compared to 12 metal ceramic and 10 lithium disilicate counterparts). They found that were no significant differences between the studied crown systems. No difference of the gingival response among the different crown systems. Eighty percent of zirconia crowns needed no occlusal adjustment; also it showed the least amount of marginal discrepancy.
- Conditions
- Wear, Tooth, Wear, Occlusal
- Being tested
- glazed zirconium lithium silicate, polished zirconium lithium silicate
- Keywords
- ZLS, crowns, occlusal wear, glass ceramic, polished vs glazed
- Medical subject headings
- Tooth Wear, Tooth Attrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glazed zirconium lithium silicateOther
Also called glazed Celtra due
monolithic glazed crown
polished zirconium lithium silicateOther
Also called polished Celtra due
monolithic polishedcrowns
| Study group | Role | What they receive |
|---|---|---|
| monolithic glazedcrowns | Active comparator | glazed Celtra due crowns Receives: Other: glazed zirconium lithium silicate |
| monolithic polished crowns | Experimental | polished Celtra due crowns Receives: Other: polished zirconium lithium silicate |
What is being measured
The primary outcome is the main question the study is designed to answer.
antagonist enamel wear
Intraoral digital scanner and superimposition software Mm3
intraoral scanning of enamel antagonist to determine amount of wear in Mm3
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start10 Jul 2021 (estimated)
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Wear, ToothStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patient will receive a restoration with superior function, esthetics, and excellent clinical performance
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Sameh Rady, Cairo University
- Investigators
- Eman M Anwer, professor, Principal investigator, professor of fixed prosthodonticskarim Abo Bakr Mohamed, PhD, Study director, teacher of fixed prosthodontics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04914962
- Sponsor's protocol ID
- Wear & ZLS
- Acronym
- zls
- Status last verified
- Jun 2021
- First submitted
- 29 May 2021
- Last updated
- 7 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
De Angelis F, D'Arcangelo C, Maliskova N, Vanini L, Vadini M. Wear Properties of Different Additive Restorative Materials Used for Onlay/Overlay Posterior Restorations. Oper Dent. 2020 May/Jun;45(3):E156-E166. doi: 10.2341/19-115-L. Epub 2020 Feb 13.
PubMed 32053459Mehta SB, Banerji S, Millar BJ, Suarez-Feito JM. Current concepts on the management of tooth wear: part 1. Assessment, treatment planning and strategies for the prevention and the passive management of tooth wear. Br Dent J. 2012 Jan 13;212(1):17-27. doi: 10.1038/sj.bdj.2011.1099.
PubMed 22240686Dahl BL, Carlsson GE, Ekfeldt A. Occlusal wear of teeth and restorative materials. A review of classification, etiology, mechanisms of wear, and some aspects of restorative procedures. Acta Odontol Scand. 1993 Oct;51(5):299-311. doi: 10.3109/00016359309040581.
PubMed 8279271Nazirkar GS, Patil SV, Shelke PP, Mahagaonkar P. Comparative evaluation of natural enamel wear against polished yitrium tetragonal zirconia and polished lithium disilicate - An in vivo study. J Indian Prosthodont Soc. 2020 Jan-Mar;20(1):83-89. doi: 10.4103/jips.jips_218_19. Epub 2020 Jan 27.
PubMed 32089603Batson ER, Cooper LF, Duqum I, Mendonca G. Clinical outcomes of three different crown systems with CAD/CAM technology. J Prosthet Dent. 2014 Oct;112(4):770-7. doi: 10.1016/j.prosdent.2014.05.002. Epub 2014 Jun 28.
PubMed 24980739
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wear of Enamel Antagonist to Polished Versus Glazed Zirconia Reinforced Lithium Silicate Crowns (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT04914962
- Acronym / sponsor ID
- zls / Wear & ZLS
- Conditions
- Wear, Tooth, Wear, Occlusal
- Keywords
- ZLS, crowns, occlusal wear, glass ceramic, polished vs glazed
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Jul 2021 (estimated)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 7 Jun 2021 (actual)
- 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.
The aim of this study is to evaluate the antagonist enamel wear of two processing options of Celtra duo crowns (polished and glaze fired) restoring posterior teeth in comparison with sound enamel wear at baseline and 6 months
Detailed description
Adhesive dental ceramics have proven to guarantee optimal esthetic results alongside satisfactory mechanical properties. Due to these qualities, today they are considered the first-choice restorative materials both for minimal restorations and for the reconstruction of severely compromised teeth. Gold alloy reconstructions preferred in the past, especially for their optimal wear properties, have been progressively substituted by these new materials.
Loss of hard tooth substance is a natural process taking place during mastication. Also, Increased wear is a common reason of failure for restorations exposed to masticatory forces. Excessive wear may be responsible for numerous problems, such as hypersensitivity, loss of occlusal contact, defects of the periodontium, reduction of masticatory efficiency, tooth migration and wrong tooth relations, weakness of masticatory muscles, and changes in the vertical and horizontal jaw relations, which may cause functional and esthetic impairments.
An optimal restorative material should provide similar characteristics to natural dental tissues. The physiological wear of enamel and dentin should represent the reference for a reasonable wear pattern of restorative materials The manufacturers tend to improve the mechanical behavior of their products leads to the progressive offer of new ceramics for daily practice. Assessment of their wear behavior and comparison through detailed tests become necessary at this point.
comparing the wear of enamel opposing polished zirconia, polished lithium disilicate crowns opposing to natural tooth. Patients were recalled after 1year and impression were recorded with opposing arch and baseline and final cast were scanned and superimposed using 3 D scanner. They found that the mean of occlusal wear of the antagonistic enamel of polished zirconia was 42.0 μm, Enamel wear against natural antagonist (control group) 34.68 μm, whereas, for Enamel wear against polished lithium disilicate crowns (group 2) 40.06 μm Enamel wear against natural antagonist (control group) 35.09 μm.
studying the quality of CAD/CAM fabricated single tooth restorations (Ten zirconia restorations were compared to 12 metal ceramic and 10 lithium disilicate counterparts). They found that were no significant differences between the studied crown systems. No difference of the gingival response among the different crown systems. Eighty percent of zirconia crowns needed no occlusal adjustment; also it showed the least amount of marginal discrepancy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Patient will receive a restoration with superior function, esthetics, and excellent clinical performance
| Arm | Type | Receives |
|---|---|---|
| monolithic glazedcrowns | Active comparator | Other: glazed zirconium lithium silicateglazed Celtra due crowns |
| monolithic polished crowns | Experimental | Other: polished zirconium lithium silicatepolished Celtra due crowns |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Pt aged 21-60 years old, be able to read and sign the informed consent document.
- Psychologically and physically able to withstand conventional dental procedures.
- Patients needing posterior full coverage restorations
- Patients with sound natural antagonists.
- Have no active periodontal or pulpal diseases
Key exclusion criteria (7 listed)
- Patients with poor oral hygiene, high caries risk and uncooperative patients.
- Pregnant women.
- Psychiatric problems or unrealistic expectations.
- Lack of opposing dentition in the area of interest.
- Restored occlusal surface opposing the planned restoration.
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 |
|---|---|---|
| glazed zirconium lithium silicateAlso: glazed Celtra duemonolithic glazed crown | Other | monolithic glazedcrowns |
| polished zirconium lithium silicateAlso: polished Celtra duemonolithic polishedcrowns | Other | monolithic polished crowns |
Primary outcome
antagonist enamel wear
Time frame: 6 months
Intraoral digital scanner and superimposition software Mm3 intraoral scanning of enamel antagonist to determine amount of wear in Mm3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2021.
- Background: PubMed 32053459De Angelis F, D'Arcangelo C, Maliskova N, Vanini L, Vadini M. Wear Properties of Different Additive Restorative Materials Used for Onlay/Overlay Posterior Restorations. Oper Dent. 2020 May/Jun;45(3):E156-E166. doi: 10.2341/19-115-L. Epub 2020 Feb 13.
- Background: PubMed 22240686Mehta SB, Banerji S, Millar BJ, Suarez-Feito JM. Current concepts on the management of tooth wear: part 1. Assessment, treatment planning and strategies for the prevention and the passive management of tooth wear. Br Dent J. 2012 Jan 13;212(1):17-27. doi: 10.1038/sj.bdj.2011.1099.
- Background: PubMed 8279271Dahl BL, Carlsson GE, Ekfeldt A. Occlusal wear of teeth and restorative materials. A review of classification, etiology, mechanisms of wear, and some aspects of restorative procedures. Acta Odontol Scand. 1993 Oct;51(5):299-311. doi: 10.3109/00016359309040581.
- Background: PubMed 32089603Nazirkar GS, Patil SV, Shelke PP, Mahagaonkar P. Comparative evaluation of natural enamel wear against polished yitrium tetragonal zirconia and polished lithium disilicate - An in vivo study. J Indian Prosthodont Soc. 2020 Jan-Mar;20(1):83-89. doi: 10.4103/jips.jips_218_19. Epub 2020 Jan 27.
- Background: PubMed 24980739Batson ER, Cooper LF, Duqum I, Mendonca G. Clinical outcomes of three different crown systems with CAD/CAM technology. J Prosthet Dent. 2014 Oct;112(4):770-7. doi: 10.1016/j.prosdent.2014.05.002. Epub 2014 Jun 28.
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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.
Eman M Anwer, professor principal investigator
professor of fixed prosthodontics
karim Abo Bakr Mohamed, PhD study director
teacher of fixed prosthodontics
Questions about this trial
What is this clinical trial studying?
A study testing glazed zirconium lithium silicate and polished zirconium lithium silicate in people with Wear, Tooth and Wear, Occlusal, run by Cairo University.
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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 7 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ibrahim S Rady, Master (0201099576840, ibrahim.rady@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
antagonist enamel wear (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04914962, which also lists 5 linked publications.
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 7 Jun 2021.