Dental VeneersNCT05751616
A Clinical Trial of the Impact of Speed and Conventional Sintering on Ultra-thin, Highly Translucent, Multilayered Zirconia Laminate Restorations
A study testing Laminate veneers with speed sintering and Laminate veneers with conventional sintering in people with Dental Veneers, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
A Minimally invasive esthetic restorative approach with the advancement of highly translucent multilayered monolithic zirconia ceramic can provide minimal thickness that affords high strength and esthetics without the need for layering porcelain. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Dental Veneers
- What is being tested?
- Laminate veneers with speed sintering and Laminate veneers with conventional sintering
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2023to 30 Dec 2023
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients able to understand and sign the informed consent form.
- physically and psychologically able to undergo conventional restorative procedures.
- Good oral hygiene with no signs of periapical pathology or periodontal disease. (periodontal screening index 0-1).
- Slight malposition.
- Teeth with spacing.
- Teeth with discoloration.
- Patient having natural teeth as opposing dentition
Who cannot join
- Insufficient surface enamel (60%).
- Abutments with subgingival restorations or root caries.
- Parafunctional habits.
- Lack of opposite occluding dentition in the area intended for restoration.
- mandibular prognathism and maxillary retrognathism
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Outpatient clinics of Faculty of Dentistry, Alexandria University, Egypt
Alexandria, Azarita, 00203
Faculty of Dentistry, (203) 4868308
Mahinour A El Moniem, Msc
About this study
Official title: Effect of Speed Sintering on Translucency and Microstructure of High Versus Low Translucent Zirconia Veneers: a Randomized Clinical Trial
A Minimally invasive esthetic restorative approach with the advancement of highly translucent multilayered monolithic zirconia ceramic can provide minimal thickness that affords high strength and esthetics without the need for layering porcelain. The effect of sintering conditions on yttria-partially stabilized zirconia is essential for the long-term success of such restorations.
The study aims to evaluate the clinical performance of speed and conventional sintering on ultra-thin, highly translucent, multilayered zirconia laminate restorations with minimum invasive tooth preparation.
- Conditions
- Dental Veneers
- Being tested
- Laminate veneers with speed sintering, Laminate veneers with conventional sintering
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laminate veneers with speed sinteringOther
Zirconia specimens will be sintered using speed sintering cycle in a conventional furnace according to the manufacturer instructions.
Laminate veneers with conventional sinteringOther
Zirconia specimens will be sintered using conventional sintering cycle in a conventional furnace according to the manufacturer instructions.
| Study group | Role | What they receive |
|---|---|---|
| Conventional sintering | Active comparator | Not described Receives: Other: Laminate veneers with conventional sintering |
| Speed sintering | Experimental | Not described Receives: Other: Laminate veneers with speed sintering |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in clinical performance
Patients will be recalled every 3 months for one year follow up. The clinical evaluation and color measurement will be based on the modified California Dental Association (CDA)/Ryge criteria of evaluation as shown
Examiners will evaluate the zirconia Veneers for the following:
- Color match.
- Zirconia surface.
- Marginal discoloration.
- Marginal integrity.
- Clinical evaluation of the completed restorations will be performed using a double-blind assessment method
Measured: Baseline, 3 months, 6 months, 9 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 posted2 Mar 2023
- Study start1 Feb 2023
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental VeneersStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05751616
- Sponsor's protocol ID
- TP_22
- Status last verified
- Feb 2023
- First submitted
- 21 Feb 2023
- Last updated
- 2 Mar 2023
- 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 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Speed Sintering on Translucency and Microstructure of High Versus Low Translucent Zirconia Veneers: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05751616
- Acronym / sponsor ID
- TP_22
- Conditions
- Dental Veneers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 2 Mar 2023 (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.
A Minimally invasive esthetic restorative approach with the advancement of highly translucent multilayered monolithic zirconia ceramic can provide minimal thickness that affords high strength and esthetics without the need for layering porcelain. The effect of sintering conditions on yttria-partially stabilized zirconia is essential for the long-term success of such restorations.
The study aims to evaluate the clinical performance of speed and conventional sintering on ultra-thin, highly translucent, multilayered zirconia laminate restorations with minimum invasive tooth preparation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional sintering | Active comparator | Other: Laminate veneers with conventional sintering |
| Speed sintering | Experimental | Other: Laminate veneers with speed sintering |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- patients able to understand and sign the informed consent form.
- physically and psychologically able to undergo conventional restorative procedures.
- Good oral hygiene with no signs of periapical pathology or periodontal disease. (periodontal screening index 0-1).
- Slight malposition.
- Teeth with spacing.
Key exclusion criteria (5 listed)
- Insufficient surface enamel (60%).
- Abutments with subgingival restorations or root caries.
- Parafunctional habits.
- Lack of opposite occluding dentition in the area intended for restoration.
- mandibular prognathism and maxillary retrognathism
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 |
|---|---|---|
| Laminate veneers with speed sinteringZirconia specimens will be sintered using speed sintering cycle in a conventional furnace according to the manufacturer instructions. | Other | Speed sintering |
| Laminate veneers with conventional sinteringZirconia specimens will be sintered using conventional sintering cycle in a conventional furnace according to the manufacturer instructions. | Other | Conventional sintering |
Primary outcome
Change in clinical performance
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months
Patients will be recalled every 3 months for one year follow up. The clinical evaluation and color measurement will be based on the modified California Dental Association (CDA)/Ryge criteria of evaluation as shown Examiners will evaluate the zirconia Veneers for the following: 1. Color match. 2. Zirconia surface. 3. Marginal discoloration. 4. Marginal integrity. 5. Clinical evaluation of the completed restorations will be performed using a double-blind assessment method
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laminate veneers with speed sintering and Laminate veneers with conventional sintering in people with Dental Veneers, run by Hams Hamed Abdelrahman 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 7 inclusion and 5 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 2 Mar 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahinour A El Moniem, Msc (01060080088 ext. 002, Dr.Mahinour_Ahmed@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in clinical performance (time frame: Baseline, 3 months, 6 months, 9 months, 12 months). 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 2 Mar 2023.