Dental Disorders Hard Tissues of TeethNCT04840524
Effect of Preparation Design on the Functional and Esthetic Outcome of CAD/CAM Lithium Disilicate Laminate Veneers
A study testing Laminate veneers preparation in people with Dental Disorders Hard Tissues of Teeth and Tooth Discoloration, run by Cairo University at 1 site in Egypt.
Trial summary
Conservatism is considered the main concern in any treatment plan, the feather edge preparation design of laminate veneers have been introduced yet clinical studies are lacking to evaluate their clinical performance.The aim of this study is to evaluate the effect of the two different preparation designs on the… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Disorders Hard Tissues of Teeth, Tooth Discoloration
- What is being tested?
- Laminate veneers preparation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Jan 2021to Jul 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- From 18-60 years old, and able to read and sign the informed consent document.
- Patients with teeth problems indicated for laminate veneers.
- Physically and psychologically able to tolerate conventional restorative procedures.
- Have no active periodontal or pulpal diseases.
- Maintenance of good oral hygiene .
- Willing to return for follow-up examinations and evaluation.
Who cannot join
- Patients in the growth stage with partially erupted teeth.
- Patients with para-functional habits.
- Cases that need modification in the incisal edge.
- Patients with poor oral hygiene and motivation .
- Psychiatric problems or unrealistic expectations.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Preparation Design on the Functional and Esthetic Outcome of CAD/CAM Lithium Disilicate Laminate Veneers (Split Mouth Randomized Clinical Trial)
Conservatism is considered the main concern in any treatment plan, the feather edge preparation design of laminate veneers have been introduced yet clinical studies are lacking to evaluate their clinical performance.The aim of this study is to evaluate the effect of the two different preparation designs on the functional and esthetic outcome of laminate veneers in terms of marginal adaptation, retention, fracture, marginal discoloration and patient satisfaction
- Being tested
- Laminate veneers preparation
- Keywords
- Laminates, Vertical preparation, veneers
- Medical subject headings
- Tooth Discoloration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laminate veneers preparationProcedure or surgery
facial laminate veneers teeth preparation
| Study group | Role | What they receive |
|---|---|---|
| Conventional preparation design (Chamfer finish line with Butt joint incisal preparation design) | Other | conventional treatment Receives: Procedure: Laminate veneers preparation |
| New preparation design (Feather edge finish line with feather edge incisal preparation design) | Experimental | New preparation design Receives: Procedure: Laminate veneers preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
marginal gap distance
the gap between the laminate and the prepared tooth is measured before cementation using silicon replica and digital microscope
Measured: at time of laminate cementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start26 Jan 2021
- Primary completionJan 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Disorders Hard Tissues of TeethStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Baher Ahmed Moustafa Ali, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04840524
- Sponsor's protocol ID
- 20-1-21
- Other IDs
- 20-1-21
- Status last verified
- Jun 2021
- First submitted
- 7 Apr 2021
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preparation Design on the Functional and Esthetic Outcome of CAD/CAM Lithium Disilicate Laminate Veneers (Split Mouth Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT04840524
- Acronym / sponsor ID
- 20-1-21
- Keywords
- Laminates, Vertical preparation, veneers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 26 Jan 2021 (actual)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 12 Apr 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.
Conservatism is considered the main concern in any treatment plan, the feather edge preparation design of laminate veneers have been introduced yet clinical studies are lacking to evaluate their clinical performance.The aim of this study is to evaluate the effect of the two different preparation designs on the functional and esthetic outcome of laminate veneers in terms of marginal adaptation, retention, fracture, marginal discoloration and patient satisfaction
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional preparation design (Chamfer finish line with Butt joint incisal preparation design) | Other | Procedure: Laminate veneers preparationconventional treatment |
| New preparation design (Feather edge finish line with feather edge incisal preparation design) | Experimental | Procedure: Laminate veneers preparationNew preparation design |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- From 18-60 years old, and able to read and sign the informed consent document.
- Patients with teeth problems indicated for laminate veneers.
- Physically and psychologically able to tolerate conventional restorative procedures.
- Have no active periodontal or pulpal diseases.
- Maintenance of good oral hygiene .
Key exclusion criteria (5 listed)
- Patients in the growth stage with partially erupted teeth.
- Patients with para-functional habits.
- Cases that need modification in the incisal edge.
- Patients with poor oral hygiene and motivation .
- Psychiatric problems or unrealistic expectations.
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 preparationfacial laminate veneers teeth preparation | Procedure or surgery | Conventional preparation design (Chamfer finish line with Butt joint incisal preparation design), New preparation design (Feather edge finish line with feather edge incisal preparation design) |
Primary outcome
marginal gap distance
Time frame: at time of laminate cementation
the gap between the laminate and the prepared tooth is measured before cementation using silicon replica and digital microscope
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
- Individual participant dataSharing planned: No
Related trials for Dental Disorders Hard Tissues of Teeth
Not yet recruitingObservational study
Salivary Function and Dental Changes During GLP-1 Therapy
Obesity, Dental Erosion
Recruiting
State of the Art Immediate Implant Placement in the Premaxilla
Bone Resorption
Not yet recruiting
Assessment of Hard and Soft Tissue Changes Following XCM Versus FGG Simultaneous With Delayed Dental Implant Placement
Missing Teeth
Recruiting
Clinical Evaluation of Full Contour Zirconia Chairside CAD/CAM Crowns
Dental Disorders Hard Tissues of Teeth, Dental Diseases
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 Laminate veneers preparation in people with Dental Disorders Hard Tissues of Teeth and Tooth Discoloration, 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 6 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 18 Jun 2021. 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?
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 gap distance (time frame: at time of laminate cementation). 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 18 Jun 2021.