Retention, Color Match, Marginal Adaptation and Restoration IntegrityNCT04598737
Assessment of Anterior Teeth Restored With Ultra-translucent Multilayer Zirconia vs Lithium Disilicate Laminate Veneers
A study testing Ultra-translucent multilayer zirconia and Lithium disilicate in people with Retention, Color Match, Marginal Adaptation and Restoration Integrity, run by Cairo University.
Trial summary
The aim of the present study is to assess the clinical performance of multilayered translucent zirconia laminate veneers versus lithium disilicate laminate veneers in terms of modified USPHS criteria for assessment of dental restorations (retention, restoration integrity, color match and marginal adaptation) Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Retention, Color Match, Marginal Adaptation and Restoration Integrity
- What is being tested?
- Ultra-translucent multilayer zirconia and Lithium disilicate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- 18 Oct 2020to Nov 2021
- 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- sufficient sound enamel thickness
- Presence of one adjacent natural teeth that doesn't need laminate to compare shade
- age range 20 to 40 years old
- non smokers
- diastema less than 2mm
- tooth fracture not exceeding incisal one third
Show all 9Show fewer
- normal occlusion
- vital teeth
- healthy periodontal tissues
Who cannot join
- -insufficient enamel thickness
- restoration more than 40 % of tooth surface
- parafunctional habits
- deep discoloration
- sever teeth rotation
- edge to edge or deep bite
- abnormal occlusion
- bad oral hygiene
About this study
Official title: Clinical Assessment of Anterior Teeth Restored With Ultra-translucent Multilayer Zirconia Versus Lithium Disilicate Laminate Veneers (Randomized Clinical Trial)
The aim of the present study is to assess the clinical performance of multilayered translucent zirconia laminate veneers versus lithium disilicate laminate veneers in terms of modified USPHS criteria for assessment of dental restorations (retention, restoration integrity, color match and marginal adaptation)
Read the detailed description
inferior mechanical properties of glass ceramics necessities the continuous development and modification for materials suitable for all clinical situations
multilayered translucent zirconia provides the advantages of high mechanical properties than all glass ceramic in addition to the improved translucency in the new generations.
Therefore, the purpose of the present study is to evaluate the clinical performance of newly introduced multilayered translucent zirconia as a monolithic laminate veneer in comparison with lithium disilicate laminate veneer to determine the clinical functional and structural integrity of the restoration
- Being tested
- Ultra-translucent multilayer zirconia, Lithium disilicate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultra-translucent multilayer zirconiaProcedure or surgery
Ultra-translucent multilayer zirconia laminate veneer treatment
Lithium disilicateProcedure or surgery
Lithium disilicate laminate veneer treatment
| Study group | Role | What they receive |
|---|---|---|
| Ultra-translucent multilayer zirconia | Experimental | Ultra-translucent multilayer zirconia laminate veneer treatment Receives: Procedure: Ultra-translucent multilayer zirconia |
| Lithium disilicate | Experimental | Lithium disilicate laminate veneer treatment Receives: Procedure: Lithium disilicate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention
assessment of restoration will be done for retention on the base of of modified USPHS criteria for assessment of dental restorations
Measured: 12 months follow up period
Secondary outcomes (1)
Restoration integrity
assessment of restoration will be done for restoration integrity on the base of of modified USPHS criteria for assessment of dental restorations
Measured: 12 months follow up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start18 Oct 2020 (estimated)
- Primary completionOct 2021 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retention, Color Match, Marginal Adaptation and Restoration IntegrityStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud abd alkarim ahmed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04598737
- Sponsor's protocol ID
- multilayer zirconia laminate
- Status last verified
- Oct 2020
- First submitted
- 15 Oct 2020
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of Anterior Teeth Restored With Ultra-translucent Multilayer Zirconia Versus Lithium Disilicate Laminate Veneers (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT04598737
- Acronym / sponsor ID
- multilayer zirconia laminate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 18 Oct 2020 (estimated)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 22 Oct 2020 (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 the present study is to assess the clinical performance of multilayered translucent zirconia laminate veneers versus lithium disilicate laminate veneers in terms of modified USPHS criteria for assessment of dental restorations (retention, restoration integrity, color match and marginal adaptation)
Detailed description
inferior mechanical properties of glass ceramics necessities the continuous development and modification for materials suitable for all clinical situations
multilayered translucent zirconia provides the advantages of high mechanical properties than all glass ceramic in addition to the improved translucency in the new generations.
Therefore, the purpose of the present study is to evaluate the clinical performance of newly introduced multilayered translucent zirconia as a monolithic laminate veneer in comparison with lithium disilicate laminate veneer to determine the clinical functional and structural integrity of the restoration
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultra-translucent multilayer zirconia | Experimental | Procedure: Ultra-translucent multilayer zirconiaUltra-translucent multilayer zirconia laminate veneer treatment |
| Lithium disilicate | Experimental | Procedure: Lithium disilicateLithium disilicate laminate veneer treatment |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- sufficient sound enamel thickness
- Presence of one adjacent natural teeth that doesn't need laminate to compare shade
- age range 20 to 40 years old
- non smokers
- diastema less than 2mm
Key exclusion criteria (8 listed)
- -insufficient enamel thickness
- restoration more than 40 % of tooth surface
- parafunctional habits
- deep discoloration
- sever teeth rotation
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 |
|---|---|---|
| Ultra-translucent multilayer zirconiaUltra-translucent multilayer zirconia laminate veneer treatment | Procedure or surgery | Ultra-translucent multilayer zirconia |
| Lithium disilicateLithium disilicate laminate veneer treatment | Procedure or surgery | Lithium disilicate |
Primary outcome
Retention
Time frame: 12 months follow up period
assessment of restoration will be done for retention on the base of of modified USPHS criteria for assessment of dental restorations
1 secondary outcome
Restoration integrity
Time frame: 12 months follow up period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Ultra-translucent multilayer zirconia and Lithium disilicate in people with Retention, Color Match, Marginal Adaptation and Restoration Integrity, 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 9 inclusion and 8 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 22 Oct 2020. 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?
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 (time frame: 12 months follow up period). 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 22 Oct 2020.