Ultra Translucent ZirconiaNCT07113873
Patient Satisfaction and Clinical Performance of Ultra-translucent Multi-layer Monolithic Zirconia and Lithium Disilicate Ceramic Laminate Veneers. Randomized Control Clinical Trial
A study testing ultra-translucent monolithic multi layered zirconia and lithium disilcate ceramics in people with Ultra Translucent Zirconia, run by Cairo University at 1 site in Egypt.
Trial summary
Despite of the improved esthetics of ultra-translucent zirconia, bonding between resin cement and zirconia is difficult to achieve because of their chemical inertness and lack of silica content. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Ultra Translucent Zirconia
- What is being tested?
- ultra-translucent monolithic multi layered zirconia and lithium disilcate ceramics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Jun 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1- Age between 18 and 50 years. 2. Absence of abnormal functional habits such as bruxism. 3. Good condition of gingival and periodontal tissues. 4. Good oral health. 5. A clear indication for patients for treatment with ceramic laminate veneers: Presence of diastema, moderate discolored dental restorations, slight modification of color in the discolored teeth, and modification of shape and sizes of the teeth.
- 6. Patient commitment for attending follow up session
Who cannot join
- Age under 18 years
- Bad oral hygiene
- Dysfunctional habits and bruxism
- Periodontal diseases
- High risk of caries
- Inadequate enamel for bonding
- Extreme staining and color change in tooth -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo
MOHAMED ALI, Phd, 01152115113, mohamed.abdelghany@dentistry.cu.edu.eg
About this study
Official title: Clinical Performance of Ultra-translucent Multi-layer Monolithic Zirconia and Lithium Disilicate Ceramic Laminate Veneers
Despite of the improved esthetics of ultra-translucent zirconia, bonding between resin cement and zirconia is difficult to achieve because of their chemical inertness and lack of silica content. However, the effect of the bond strength with the new generation of high-translucent zirconia materials is not clear and further studies are needed. Kongkiatkamon, Suchada et al., (2023) The long-term bond strength of cubic zirconia was similar to 3Y-TZP zirconia and lithium disilicate ceramics and showed sufficient bond strength. A 5-mol% yttria-stabilized tetragonal Zr polycrystal showed high shear bond strength similar to Li disilicate glass-ceramic. Air blasting of Zr followed by primers and resin cements based on 10-MDP monomer has proven its efficiency in Zr-resin bonding. Both ultra-translucent 5Y-PSZ Zr and Li disilicate offer viable options for esthetic restorations on anterior teeth Adak et al. (2023),Elsisi et al. (2024) Currently, there is a lack of reports in the literature regarding the long-term clinical performance of ultra-translucent zirconia, especially considering its use in manufacturing monolithic veneers. Therefore, the purpose of the present clinical trial is to assess the validity of using ultra-translucent multi-layer zirconia ceramic veneer as an alternative to lithium disilicate ceramic veneer
Read the detailed description
Preservation of tooth structure and prevention of needless tooth structure removal are basic and important principles in prosthodontics. Striving to achieve the cosmetic aspect is also a basic requirement, especially in the modern world Fawakhiri et al. (2023) Porcelain laminate veneers are one of the most popular cosmetic and minimally invasive dental treatments. These veneers can change the color, contour, shape, and size of the teeth they cover and bond to tooth structure with the use of adhesive cements. A thin layer of enamel (0.5-.8 mm) is removed to provide space for each veneer Piemjai and Donpinprai (2023) Several ceramic materials are currently indicated for veneers: lithium disilicate, feldspathic ceramic, feldspathic reinforced with leucite, fluorapatite, and lithium silicate reinforced with zirconia. All of these ceramics exhibit high translucency characteristics due to the high content of glassy matrix in their composition, thus providing highly satisfactory esthetics in addition to excellent adhesion to resin cement through the conditioning with hydrofluoric acid (4%-10%) followed by silanization Souza et al. (2017) Lithium disilicate ceramics belong to the silica-based ceramics family. They are commonly used for the fabrication of laminate veneers owing to their excellent optical properties, including their superior translucency and strong bonding to the tooth enamel surface when etched with hydrofluoric acid and then silanized Ojeda et al. (2023) Longevity is one of the most important factors to predict the survival and success of restorations. Many longitudinal clinical studies have evaluated the performance of ceramic veneer restorations and have confirmed good clinical performance, excellent aesthetics, and a high level of patient satisfaction. Major clinical complications commonly resulting in the failure of ceramic veneer restorations are fracture and debonding (Monaraks, 2018) The long-term clinical success of ceramic-based restorations is strongly dependent on their retention to teeth or abutment substrates by using adhesive systems and resin-matrix cements in vitro research has shown that load-to-fracture values of monolithic zirconia are higher than those of LS2; the latter, in turn, are higher than those of ZLS Zarone et al. (2019) ,(Souza et al., 2023) 6 The excellent biocompatibility and superior mechanical properties of zirconium dioxide (zirconia) ceramics make them a material of choice in prosthetic dentistry. Nevertheless, zirconia ceramics have not been used for the fabrication of laminate veneers because the opaqueness and low translucency of zirconia ceramics yield undesirable esthetic results. Due to the absence of any glassy matrix, zirconia is free from silica and, consequently, cannot be conditioned with conventional acid etching techniques, differently from glass-ceramics. Kusaba, Kosuke et al., (2018) , Zarone et al. (2019) Lately, the ultra-translucent multilayered zirconia has been introduced to the market. This material structured to replicate the naturality of teeth according to each anatomical region, keeping translucency at the incisal edge and a higher opacity at the cervical area. The multilayer blanks are pre-layered and thus contain different shades. There is scientific evidence reporting that the darker the color the higher the degree of opacity, that's to say the lower the translucency becomes. The color of the blanks is increasingly lighter and thus more translucent towards the incisal area. The dental technician can use CAD software to help to determine color sequences and intensities by positioning the constructed restoration in the blank. One advantage resulting from the combination of highly esthetic (color and translucency values are similar to those of natural teeth) and highly stable materials is better treatment with restorations with low space requirements. This Ultra-translucent Zirconia ceramic veneers have a minimum thickness of 0.1-0.3 mm, a more conservative option than glass-ceramic restorations Alqutaibi et al. (2022), Gomes et al., (2022), ("Three Generations of Zirconia: From Veneered to Monolithic. Part I.," 2017)
- Conditions
- Ultra Translucent Zirconia
- Being tested
- ultra-translucent monolithic multi layered zirconia, lithium disilcate ceramics
- Keywords
- veneer, monolithic zirconia, lithium disilicate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultra-translucent monolithic multi layered zirconiaOther
laminate veneer
lithium disilcate ceramicsOther
laminate veneer
| Study group | Role | What they receive |
|---|---|---|
| lithium disilicate veneer | Active comparator | After tooth preparation to receive conservative Emax veneers all preparation will be finished to provide smooth topography and allow maximum stability to the final restoration tooth surface and restoration surface will be treated according to the recommended protocol to attain best results Receives: Other: lithium disilcate ceramics |
| ultra translucent monolithic multi layered zirconia veneer | Experimental | Tooth preparation will be done using a turbine hand piece, minimal preparation will be resorted to by adopting the butt joint pattern that guarantees shortening the cutting edge to obtain the required translucent and esthetic aspect. The incisal edge will be prepared by depth guide stone; this will be followed by preparing the cervical region 0.1-0.3mm and the mid-region 0.3-0.5 mm The cutting edge will be reduced by 1.0-1.5 mm. After removing the enamel via a cone round-end stone to reach the required depth, the finishing lines will be adopting the light chamfer scheme. Moreover, the preparation will be extended to a labial surface without exceeding the interproximal contact, rounding all the edges and linear angles. Later,10 manufacturing the veneers will follow the exact laboratory steps for both the zirconia group. Receives: Other: ultra-translucent monolithic multi layered zirconia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction
Numerical (discrete) ("0" unsatisfied - "10" satisfied)
Measured: 24 month
Secondary outcomes (4)
Color Stability
ΔE<2.7
Measured: 24 month
Marginal Integrity
Alpha (A) No visible evidences of crevice along the margins; no catch or penetration of the explorer.
- Bravo (B) Visible evidence of crevice and/or catch of explorer; no penetration of the explorer.
- Charlie (C) Visible evidence of crevice and penetration of the explorer
Measured: 24 month
Gingival Health
- Alpha (A) Normal gingiva
- Bravo (B) Mild inflammation - slight change in color and slight edema but no bleeding on probing 11 13-Participant timeline
The patient will be treated in a regular sequence:
visit 1: proper examination for the participants (clinically and radiographically) and alginate impressions for diagnosis on primary casts and for mounting Visit 2: Preparation for abutment teeth, final impression using elastic impression material and provisional restoration.
Visit 3: permanent cementation of the final restoration Visit 4: follow-up every 3month for 24 months 14-Calculated sample size: Sample size calculated depending on a previous study by Verniani et al. (2024) as reference. According to this study, the minimally accepted sample size was 7 per group, when mean ± standard deviation of patient satisfaction at baseline in-group I was 7.1±1.5 while after 2 years was 9.5 ±2, with 1.33 effect size, when the power was 80 % \& type I error probability was 0.05. Total sample si
Measured: 24 month
Retention
- Alpha (A)No loss of restorative material
- Bravo (B) Partial loss of restorative material
- Charlie (C) Missing restoration
Measured: 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start2 Jun 2025
- Primary completion2 Jan 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultra Translucent ZirconiaStudies 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
- zirconia monolithic ultra-translucent veneers
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MOHAMED ALI, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07113873
- Sponsor's protocol ID
- 2025-1
- Status last verified
- Jan 2026
- First submitted
- 3 Aug 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Ultra-translucent Multi-layer Monolithic Zirconia and Lithium Disilicate Ceramic Laminate Veneers
- ClinicalTrials.gov ID
- NCT07113873
- Acronym / sponsor ID
- 2025-1
- Conditions
- Ultra Translucent Zirconia
- Keywords
- veneer, monolithic zirconia, lithium disilicate
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- 2 Jan 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Aug 2025 (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.
Despite of the improved esthetics of ultra-translucent zirconia, bonding between resin cement and zirconia is difficult to achieve because of their chemical inertness and lack of silica content. However, the effect of the bond strength with the new generation of high-translucent zirconia materials is not clear and further studies are needed. Kongkiatkamon, Suchada et al., (2023) The long-term bond strength of cubic zirconia was similar to 3Y-TZP zirconia and lithium disilicate ceramics and showed sufficient bond strength. A 5-mol% yttria-stabilized tetragonal Zr polycrystal showed high shear bond strength similar to Li disilicate glass-ceramic. Air blasting of Zr followed by primers and resin cements based on 10-MDP monomer has proven its efficiency in Zr-resin bonding. Both ultra-translucent 5Y-PSZ Zr and Li disilicate offer viable options for esthetic restorations on anterior teeth Adak et al. (2023),Elsisi et al. (2024) Currently, there is a lack of reports in the literature regarding the long-term clinical performance of ultra-translucent zirconia, especially considering its use in manufacturing monolithic veneers. Therefore, the purpose of the present clinical trial is to assess the validity of using ultra-translucent multi-layer zirconia ceramic veneer as an alternative to lithium disilicate ceramic veneer
Detailed description
Preservation of tooth structure and prevention of needless tooth structure removal are basic and important principles in prosthodontics. Striving to achieve the cosmetic aspect is also a basic requirement, especially in the modern world Fawakhiri et al. (2023) Porcelain laminate veneers are one of the most popular cosmetic and minimally invasive dental treatments. These veneers can change the color, contour, shape, and size of the teeth they cover and bond to tooth structure with the use of adhesive cements. A thin layer of enamel (0.5-.8 mm) is removed to provide space for each veneer Piemjai and Donpinprai (2023) Several ceramic materials are currently indicated for veneers: lithium disilicate, feldspathic ceramic, feldspathic reinforced with leucite, fluorapatite, and lithium silicate reinforced with zirconia. All of these ceramics exhibit high translucency characteristics due to the high content of glassy matrix in their composition, thus providing highly satisfactory esthetics in addition to excellent adhesion to resin cement through the conditioning with hydrofluoric acid (4%-10%) followed by silanization Souza et al. (2017) Lithium disilicate ceramics belong to the silica-based ceramics family. They are commonly used for the fabrication of laminate veneers owing to their excellent optical properties, including their superior translucency and strong bonding to the tooth enamel surface when etched with hydrofluoric acid and then silanized Ojeda et al. (2023) Longevity is one of the most important factors to predict the survival and success of restorations. Many longitudinal clinical studies have evaluated the performance of ceramic veneer restorations and have confirmed good clinical performance, excellent aesthetics, and a high level of patient satisfaction. Major clinical complications commonly resulting in the failure of ceramic veneer restorations are fracture and debonding (Monaraks, 2018) The long-term clinical success of ceramic-based restorations is strongly dependent on their retention to teeth or abutment substrates by using adhesive systems and resin-matrix cements in vitro research has shown that load-to-fracture values of monolithic zirconia are higher than those of LS2; the latter, in turn, are higher than those of ZLS Zarone et al. (2019) ,(Souza et al., 2023) 6 The excellent biocompatibility and superior mechanical properties of zirconium dioxide (zirconia) ceramics make them a material of choice in prosthetic dentistry. Nevertheless, zirconia ceramics have not been used for the fabrication of laminate veneers because the opaqueness and low translucency of zirconia ceramics yield undesirable esthetic results. Due to the absence of any glassy matrix, zirconia is free from silica and, consequently, cannot be conditioned with conventional acid etching techniques, differently from glass-ceramics. Kusaba, Kosuke et al., (2018) , Zarone et al. (2019) Lately, the ultra-translucent multilayered zirconia has been introduced to the market. This material structured to replicate the naturality of teeth according to each anatomical region, keeping translucency at the incisal edge and a higher opacity at the cervical area. The multilayer blanks are pre-layered and thus contain different shades. There is scientific evidence reporting that the darker the color the higher the degree of opacity, that's to say the lower the translucency becomes. The color of the blanks is increasingly lighter and thus more translucent towards the incisal area. The dental technician can use CAD software to help to determine color sequences and intensities by positioning the constructed restoration in the blank. One advantage resulting from the combination of highly esthetic (color and translucency values are similar to those of natural teeth) and highly stable materials is better treatment with restorations with low space requirements. This Ultra-translucent Zirconia ceramic veneers have a minimum thickness of 0.1-0.3 mm, a more conservative option than glass-ceramic restorations Alqutaibi et al. (2022), Gomes et al., (2022), ("Three Generations of Zirconia: From Veneered to Monolithic. Part I.," 2017)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- zirconia monolithic ultra-translucent veneers
| Arm | Type | Receives |
|---|---|---|
| lithium disilicate veneer | Active comparator | Other: lithium disilcate ceramicsAfter tooth preparation to receive conservative Emax veneers all preparation will be finished to provide smooth topography and allow maximum stability to the final restoration tooth surface and restoration surface will be treated according to the recommended protocol to attain best results |
| ultra translucent monolithic multi layered zirconia veneer | Experimental | Other: ultra-translucent monolithic multi layered zirconiaTooth preparation will be done using a turbine hand piece, minimal preparation will be resorted to by adopting the butt joint pattern that guarantees shortening the cutting edge to obtain the required translucent and esthetic aspect. The incisal edge will be prepared by depth guide stone; this will be followed by preparing the cervical region 0.1-0.3mm and the mid-region 0.3-0.5 mm The cutting edge will be reduced by 1.0-1.5 mm. After removing the enamel via a cone round-end stone to reach the required depth, the finishing lines will be adopting the light chamfer scheme. Moreover, the preparation will be extended to a labial surface without exceeding the interproximal contact, rounding all the edges and linear angles. Later,10 manufacturing the veneers will follow the exact laboratory steps for both the zirconia group. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 1- Age between 18 and 50 years. 2. Absence of abnormal functional habits such as bruxism. 3. Good condition of gingival and periodontal tissues. 4. Good oral health. 5. A clear indication for patients for treatment with ceramic laminate veneers: Presence of diastema, moderate discolored dental restorations, slight modification of color in the discolored teeth, and modification of shape and sizes of the teeth.
- 6. Patient commitment for attending follow up session
Key exclusion criteria (7 listed)
- Age under 18 years
- Bad oral hygiene
- Dysfunctional habits and bruxism
- Periodontal diseases
- High risk of caries
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 monolithic multi layered zirconialaminate veneer | Other | ultra translucent monolithic multi layered zirconia veneer |
| lithium disilcate ceramicslaminate veneer | Other | lithium disilicate veneer |
Primary outcome
Patient Satisfaction
Time frame: 24 month
Numerical (discrete) ("0" unsatisfied - "10" satisfied)
4 secondary outcomes
Color Stability
Time frame: 24 month
Marginal Integrity
Time frame: 24 month
Gingival Health
Time frame: 24 month
Retention
Time frame: 24 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Ultra Translucent Zirconia
Not yet recruiting
Clinical Behavior and Patient Satisfaction of Zirconia-reinforced Glass-ceramic Crowns and Ultra-translucent-multilayered Monolithic Zirconia Crowns With a Conservative Marginal Design
Clinical Behavior of ZLS and UTML
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultra-translucent monolithic multi layered zirconia and lithium disilcate ceramics in people with Ultra Translucent Zirconia, run by Cairo University at 1 site in Egypt.
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 2 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: looking for participants now, as of the sponsor's last update on 6 Jan 2026. 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 Egypt. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gihan El naggar Professor, PhD (01117676668, gihan.abdelhadyelnaggar@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Satisfaction (time frame: 24 month). 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 6 Jan 2026.