Spacing of Anterior TeethNCT06472180
Sectional Versus Full Glass Ceramic Laminate Veneers
A study testing Glass ceramic sectional veneer and Glass ceramic laminate veneer in people with Spacing of Anterior Teeth, run by October University for Modern Sciences and Arts at 1 site in Egypt.
Trial summary
The aim of the study is to assess the marginal adaptation, color stability and clinical performance of glass ceramic sectional veneers compared to full laminate veneers There's two null hypotheses , the first is that there is no difference in the marginal adaptation of sectional and full glass ceramic laminate… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Spacing of Anterior Teeth
- What is being tested?
- Glass ceramic sectional veneer and Glass ceramic laminate veneer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2024to 1 May 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients seeking for esthetics with the following criteria
- Male or female patients age range above 18 years old
- Minor esthetic defects in anterior region
- Multiple spacing
- diastemas
- Incisal fracture
Show all 10Show fewer
- Initial proximal caries
- Patients able physically and psychologically to tolerate restorative procedures
- Patients willing to return for follow-up examinations and evaluation
- Class I occlusion
Who cannot join
- Patients free of:
- Tempromandibular disorders
- Para-functional habits
- Cracked teeth
- Moderate or deep caries
- Heavily discolored teeth
Show all 13Show fewer
- Heavy smokers
- Enamel defects compromising bonding
- Active periodontal disease
- Pulpal disease
- Mobility
- Occlusal disturbances
- Class II and III occlusion
Trial locations and contacts
1 site in 1 country.
Egypt1 site
October University for Modern Sciences & Arts
Giza, Giza, 6th October City, 12451
About this study
Official title: Marginal Adaptation, Color Stability and Clinical Performance of Sectional and Full Glass Ceramic Laminate Veneers. A Randomized Clinical Trial
The aim of the study is to assess the marginal adaptation, color stability and clinical performance of glass ceramic sectional veneers compared to full laminate veneers There's two null hypotheses , the first is that there is no difference in the marginal adaptation of sectional and full glass ceramic laminate veneers.
the Second is that there is no apparent change in color stability and clinical performance of sectional and full glass ceramic laminate veneers.
Read the detailed description
Although seeking for more minimally invasive treatment modalities with the use of the new advancements in ceramics and adhesive materials, however there is insufficient clinical studies assessing the ultraconservative sectional veneers has been published although there are many published case reports proving their success .
Hence the aim of this study is to assess the sectional veneers compared to laminate veneer regarding marginal adaptation, color stability and clinical performance
- Conditions
- Spacing of Anterior Teeth
- Being tested
- Glass ceramic sectional veneer, Glass ceramic laminate veneer
- Keywords
- Mini-veneers, partial veneers, porcelain fragments, sectional veneers, laminate veneers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glass ceramic sectional veneerProcedure or surgery
partial laminate veneer
Glass ceramic laminate veneerProcedure or surgery
Glass ceramic laminate veneer
| Study group | Role | What they receive |
|---|---|---|
| intervention- Glass ceramic sectional veneer | Experimental | participants receive Glass ceramic sectional veneer covering only the area of defect Receives: Procedure: Glass ceramic sectional veneer |
| control-Glass ceramic laminate veneer | Active comparator | participants receive laminate veneers made of glass ceramics as it is well documented in the literatures as successful restoration modality Receives: Procedure: Glass ceramic laminate veneer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal adaptation of sectional and full glass ceramic laminate veneer using digital device intraoral scanner
assessment of the marginal adaptation using digital device intraoral scanner software
Measured: Baseline,3,6,9,12 months
Secondary outcomes (2)
Color stability
assessment of the Color stability using intraoral scanner
Measured: Baseline,3,6,9,12 months
Clinical performance
categorical outcome of clinical performance using FDI(World Dental Federation) criteria
Measured: Baseline,3,6,9,12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start1 May 2024
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spacing of Anterior TeethStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- October University for Modern Sciences and Arts
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nehal Gamal, October University for Modern Sciences and Arts
- Investigators
- Nehal G Mohamed, BDS, Principal investigator, October University for Modern Sciences & Arts
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06472180
- Sponsor's protocol ID
- 12
- Status last verified
- Jun 2024
- First submitted
- 17 Jun 2024
- Last updated
- 25 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Marginal Adaptation, Color Stability and Clinical Performance of Sectional and Full Glass Ceramic Laminate Veneers. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06472180
- Acronym / sponsor ID
- 12
- Conditions
- Spacing of Anterior Teeth
- Keywords
- Mini-veneers, partial veneers, porcelain fragments, sectional veneers, laminate veneers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (actual)
- Lead sponsor
- October University for Modern Sciences and ArtsUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 25 Jun 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.
The aim of the study is to assess the marginal adaptation, color stability and clinical performance of glass ceramic sectional veneers compared to full laminate veneers There's two null hypotheses , the first is that there is no difference in the marginal adaptation of sectional and full glass ceramic laminate veneers.
the Second is that there is no apparent change in color stability and clinical performance of sectional and full glass ceramic laminate veneers.
Detailed description
Although seeking for more minimally invasive treatment modalities with the use of the new advancements in ceramics and adhesive materials, however there is insufficient clinical studies assessing the ultraconservative sectional veneers has been published although there are many published case reports proving their success .
Hence the aim of this study is to assess the sectional veneers compared to laminate veneer regarding marginal adaptation, color stability and clinical performance
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention- Glass ceramic sectional veneer | Experimental | Procedure: Glass ceramic sectional veneerparticipants receive Glass ceramic sectional veneer covering only the area of defect |
| control-Glass ceramic laminate veneer | Active comparator | Procedure: Glass ceramic laminate veneerparticipants receive laminate veneers made of glass ceramics as it is well documented in the literatures as successful restoration modality |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Patients seeking for esthetics with the following criteria
- Male or female patients age range above 18 years old
- Minor esthetic defects in anterior region
- Multiple spacing
- diastemas
Key exclusion criteria (13 listed)
- Patients free of:
- Tempromandibular disorders
- Para-functional habits
- Cracked teeth
- Moderate or deep 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 |
|---|---|---|
| Glass ceramic sectional veneerpartial laminate veneer | Procedure or surgery | intervention- Glass ceramic sectional veneer |
| Glass ceramic laminate veneerGlass ceramic laminate veneer | Procedure or surgery | control-Glass ceramic laminate veneer |
Primary outcome
Marginal adaptation of sectional and full glass ceramic laminate veneer using digital device intraoral scanner
Time frame: Baseline,3,6,9,12 months
assessment of the marginal adaptation using digital device intraoral scanner software
2 secondary outcomes
Color stability
Time frame: Baseline,3,6,9,12 months
Clinical performance
Time frame: Baseline,3,6,9,12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- Individual participant dataSharing planned: Undecided
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Class I Malocclusion, Crowded Teeth
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.
Nehal G Mohamed, BDS principal investigator
October University for Modern Sciences & Arts
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glass ceramic sectional veneer and Glass ceramic laminate veneer in people with Spacing of Anterior Teeth, run by October University for Modern Sciences and Arts 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 10 inclusion and 13 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 25 Jun 2024. 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 adaptation of sectional and full glass ceramic laminate veneer using digital device intraoral scanner (time frame: Baseline,3,6,9,12 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 25 Jun 2024.