Dislocation, ToothNCT06406582
Treatment Result of Zirconia Laminate Veneer
A study testing Zirconia laminate veneer and Lithium Disilicate laminate veneer in people with Dislocation, Tooth and Teeth, Endodontically-Treated, run by Hanoi Medical University at 1 site in Vietnam.
Trial summary
This study aims to evaluate the clinical performance of the zirconia laminate veneer, a minimally invasive prosthetic restoration Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Dislocation, Tooth, Teeth, Endodontically-Treated, Tooth Fracture
- What is being tested?
- Zirconia laminate veneer and Lithium Disilicate laminate veneer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteVietnam
- Study dates
- 25 Sep 2023to 31 Dec 2025
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Spaced tooth
- Discolored tooth
- Malformed tooth
- Root canal-treated tooth
- Chipped tooth
- Mildly crowded tooth
Who cannot join
- Tooth bruxism
- Inadequate enamel for bonding
- Large restoration exists
- Bad oral habits harming restoration
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
High Technical Center of Dentistry, School of Dentistry
Hanoi, Hanoi, 10000
About this study
Official title: Surface Conditioning Effectiveness, Accuracy and Treatment Result of Zirconia Laminate Veneer
This study aims to evaluate the clinical performance of the zirconia laminate veneer, a minimally invasive prosthetic restoration
Read the detailed description
Patients with indications for single tooth restoration with ceramic laminate veneers are recruited for the study. These indications include spaced, discolored, malformed, root canal-treated, chipped, and mildly crowded teeth. After providing written informed consent, all patients are randomly divided into two groups in a double-blind manner (participants and the outcomes assessor) in a 1:1 ratio, including the Zirconia group (intervention) and the Lithium Disilicate group (control). Each patient's tooth is prepared and restored with the corresponding laminate veneer material, that is, zirconia and lithium disilicate.
- Conditions
- Dislocation, Tooth, Teeth, Endodontically-Treated, Tooth Fracture, Tooth Injuries, Tooth Abnormalities, Cracked Tooth Syndrome
- Being tested
- Zirconia laminate veneer, Lithium Disilicate laminate veneer
- Keywords
- ceramic laminate veneers, zirconia, lithium disilicate, computer-aided manufacturing
- Medical subject headings
- Tooth Avulsion, Tooth, Nonvital, Tooth Fractures, Tooth Injuries, Tooth Abnormalities, Cracked Tooth Syndrome, Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zirconia laminate veneerDevice
Zirconia veneers are milled with computer-aided manufacturing technology from multilayered zirconia discs with shade matched with adjacent teeth. After sintering, veneer surfaces are treated with a hydrofluoric acid-nitric acid mixture. Next, veneers are cut back if necessary to provide space for characterization. Veneers are bonded with a light-cured veneer adhesive system (Relyx Veneer LC, 3M, USA).
Lithium Disilicate laminate veneerDevice
Lithium Disilicate veneers are milled with computer-aided manufacturing technology from lithium disilicate blocks with shade matched with adjacent teeth. After sintering, veneer surfaces are treated with hydrofluoric acid. Next, veneers are cut back if necessary to provide space for characterization. Veneers are bonded with a light-cured veneer adhesive system (Relyx Veneer LC, 3M, USA).
| Study group | Role | What they receive |
|---|---|---|
| Zirconia laminate veneer | Experimental | Intervention: Single-tooth restoration using zirconia ceramic laminate veneers.
Procedure:
Tooth preparation following standard protocols for laminate veneer placement. Fabrication of zirconia laminate veneers. Cementation of zirconia laminate veneers with appropriate bonding protocol. Follow-Up: after 2 weeks, 6 months, and 12 months Receives: Device: Zirconia laminate veneer |
| Lithium Disilicate laminate veneer | Active comparator | Intervention: Single-tooth restoration using lithium disilicate ceramic laminate veneers.
Procedure:
Tooth preparation following standard protocols for laminate veneer placement. Fabrication of lithium disilicate laminate veneers. Cementation of lithium disilicate laminate veneers with appropriate bonding protocol.
Follow-Up: after 2 weeks, 6 months, and 12 months Receives: Device: Lithium Disilicate laminate veneer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal and internal fit
Measurement of marginal and internal fit in micrometers with silicone replica method
Measured: Before veneer adhesion
Gingival health
Assessment of gingival index
Measured: 2 weeks, 6 months, 12 months
Periodontal pocket
Measurement of periodontal pocket depth in millimeters
Measured: 2 weeks, 6 months, 12 months
Evaluation criteria based on the modified United States Public Health Standard
Shade match, contour, fracture, loss of retention, hypersensitivity
Measured: 2 weeks, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start25 Sep 2023
- Primary completion31 Oct 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dislocation, 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Zirconia Group (Intervention): Participants receive zirconia laminate veneers. Lithium Disilicate Group (Control): Participants receive lithium disilicate laminate veneers. Lithium disilicate is a standard ceramic material for laminate veneers.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanoi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06406582
- Sponsor's protocol ID
- 01050122106
- Status last verified
- May 2024
- First submitted
- 3 May 2024
- Last updated
- 21 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surface Conditioning Effectiveness, Accuracy and Treatment Result of Zirconia Laminate Veneer
- ClinicalTrials.gov ID
- NCT06406582
- Acronym / sponsor ID
- 01050122106
- Conditions
- Dislocation, Tooth, Teeth, Endodontically-Treated, Tooth Fracture, Tooth Injuries, Tooth Abnormalities, Cracked Tooth Syndrome
- Keywords
- ceramic laminate veneers, zirconia, lithium disilicate, computer-aided manufacturing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hanoi Medical UniversityUniversity, hospital or other
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 9 May 2024 (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.
This study aims to evaluate the clinical performance of the zirconia laminate veneer, a minimally invasive prosthetic restoration
Detailed description
Patients with indications for single tooth restoration with ceramic laminate veneers are recruited for the study. These indications include spaced, discolored, malformed, root canal-treated, chipped, and mildly crowded teeth. After providing written informed consent, all patients are randomly divided into two groups in a double-blind manner (participants and the outcomes assessor) in a 1:1 ratio, including the Zirconia group (intervention) and the Lithium Disilicate group (control). Each patient's tooth is prepared and restored with the corresponding laminate veneer material, that is, zirconia and lithium disilicate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Zirconia Group (Intervention): Participants receive zirconia laminate veneers. Lithium Disilicate Group (Control): Participants receive lithium disilicate laminate veneers. Lithium disilicate is a standard ceramic material for laminate veneers.
| Arm | Type | Receives |
|---|---|---|
| Zirconia laminate veneer | Experimental | Device: Zirconia laminate veneerIntervention: Single-tooth restoration using zirconia ceramic laminate veneers. Procedure: Tooth preparation following standard protocols for laminate veneer placement. Fabrication of zirconia laminate veneers. Cementation of zirconia laminate veneers with appropriate bonding protocol. Follow-Up: after 2 weeks, 6 months, and 12 months |
| Lithium Disilicate laminate veneer | Active comparator | Device: Lithium Disilicate laminate veneerIntervention: Single-tooth restoration using lithium disilicate ceramic laminate veneers. Procedure: Tooth preparation following standard protocols for laminate veneer placement. Fabrication of lithium disilicate laminate veneers. Cementation of lithium disilicate laminate veneers with appropriate bonding protocol. Follow-Up: after 2 weeks, 6 months, and 12 months |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Spaced tooth
- Discolored tooth
- Malformed tooth
- Root canal-treated tooth
- Chipped tooth
Key exclusion criteria (4 listed)
- Tooth bruxism
- Inadequate enamel for bonding
- Large restoration exists
- Bad oral habits harming 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 |
|---|---|---|
| Zirconia laminate veneerZirconia veneers are milled with computer-aided manufacturing technology from multilayered zirconia discs with shade matched with adjacent teeth. After sintering, veneer surfaces are treated with a hydrofluoric acid-nitric acid mixture. Next, veneers are cut back if necessary to provide space for characterization. Veneers are bonded with a light-cured veneer adhesive system (Relyx Veneer LC, 3M, USA). | Device | Zirconia laminate veneer |
| Lithium Disilicate laminate veneerLithium Disilicate veneers are milled with computer-aided manufacturing technology from lithium disilicate blocks with shade matched with adjacent teeth. After sintering, veneer surfaces are treated with hydrofluoric acid. Next, veneers are cut back if necessary to provide space for characterization. Veneers are bonded with a light-cured veneer adhesive system (Relyx Veneer LC, 3M, USA). | Device | Lithium Disilicate laminate veneer |
Primary outcome
Marginal and internal fit
Time frame: Before veneer adhesion
Measurement of marginal and internal fit in micrometers with silicone replica method
Gingival health
Time frame: 2 weeks, 6 months, 12 months
Assessment of gingival index
Periodontal pocket
Time frame: 2 weeks, 6 months, 12 months
Measurement of periodontal pocket depth in millimeters
Evaluation criteria based on the modified United States Public Health Standard
Time frame: 2 weeks, 6 months, 12 months
Shade match, contour, fracture, loss of retention, hypersensitivity
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 21 Sep 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zirconia laminate veneer and Lithium Disilicate laminate veneer in people with Dislocation, Tooth and Teeth, Endodontically-Treated, run by Hanoi Medical University at 1 site in Vietnam.
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 4 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 21 Sep 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 Vietnam. 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?
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?
Marginal and internal fit (time frame: Before veneer adhesion). The study lists 4 primary outcomes in all. 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 21 Sep 2026.