Shade MatchNCT04774614
Shade Match, Marginal Adaptation and Patient Satisfaction of VITA ENAMIC multiColor Versus IPS e.Max CAD Veneers
A study testing anterior laminate veneers in people with Shade Match, run by Cairo University.
Trial summary
It is assumed that there will be no difference in shade match, marginal adaptation and patient satisfaction between VITA ENAMIC multiColor and IPS e.max CAD anterior laminate veneers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Shade Match
- What is being tested?
- anterior laminate veneers
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2021to 1 Apr 2022
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients aged 18-55 years, are able to read and sign the informed consent document.
- Patients who are physically and psychologically able to tolerate conventional restorative procedures.
- Patients with no active periodontal or pulpal diseases and have teeth with good restorations.
- Patients with complaints related to the esthetics in the upper or lower teeth (e.g. discoloration, fracture that does not involve more than 50% enamel loss, mild malposition)
Who cannot join
- Patients in the growth stage with partially erupted teeth.
- Patient with fractured teeth of more than 50% enamel loss.
- Patients with poor oral hygiene.
- Patient with non-vital teeth.
About this study
Official title: Shade Match, Marginal Adaptation and Patient Satisfaction of VITA ENAMIC multiColor Versus IPS e.Max CAD Anterior Laminate Veneers (Randomized Clinical Trial)
It is assumed that there will be no difference in shade match, marginal adaptation and patient satisfaction between VITA ENAMIC multiColor and IPS e.max CAD anterior laminate veneers.
Read the detailed description
Study settings:
This study will be carried out on patients enrolled from the Outpatient clinic in fixed prosthodontics clinic, Faculty of Oral and Dental Medicine, Cairo University.
Participant timeline:
The patient will be treated in visits designated as follows:
- st Visit: Preoperative records, face-to-face adherence reminder session, clinical, radiographic examination and primary impression for diagnostic cast construction.
- nd Visit: Teeth preparation, secondary impression and temporary restoration.
- rd Visit : Try in
- th Visit: Placement and permanent cementation of the final restoration. Shade match, marginal adaptation and patient satisfaction will be evaluated immediately after cementation
Data collection methods
Primary outcome (Shade match) will be assessed by using Modified United State Public Health Service Criteria (Modified USPHS Criteria).
Secondary outcomes:
Marginal adaptation will be assessed by modified USPHS criteria. Patient's satisfaction will be assessed using nominal scores (non-acceptable, acceptable, good and excellent).
Data management:
All data will be entered electronically in an Excel sheet. Patient files are to be stored in numerical order in a secured place.
Statistical methods:
- All Data will be collected, checked, revised, tabulated and entered into the computer.
- Data will be analyzed using IBM advance statistics (Statistics package for social sciences) version 21 (SPSS inc, Chicago, IL)
- Categorical data will be described as numbers and percentage
- Data will be explored for normality using Kolmogrov-smirnov test and Shapiro-wilk test
- Comparison between two groups for normally distributed numeric variables will be done by Mann-Whitney test. An equivalence limit will be tested.
- A P-value less than or equal to 0.05 will be considered statistically significant. All tests will be two tailed.
Data monitoring:
Monitoring The main supervisor is responsible of data monitoring if harms arise, interim analysis will be done.
Harms Any adverse effect like pain or even failure will be recorded, documented and treated.
Audit Auditing of the study design will be done by the evidence-based committee of the faculty of Oral and Dental medicine at Cairo University.
- Conditions
- Shade Match
- Being tested
- anterior laminate veneers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anterior laminate veneersProcedure or surgery
VITA ENAMIC multiColor
| Study group | Role | What they receive |
|---|---|---|
| VITA ENAMIC multiColor anterior laminate veneers | Experimental | Not described Receives: Procedure: anterior laminate veneers |
| IPS e.max CAD anterior laminate veneers | Active comparator | Not described Receives: Procedure: anterior laminate veneers |
What is being measured
The primary outcome is the main question the study is designed to answer.
shade match
measured by Modified United States Public Health Service criteria (USPHS criteria). Score Alpha (A): matches tooth, Bravo (B): acceptable mismatch, Charlie (C): unacceptable mismatch
Measured: immediately after restoration delivery
Secondary outcomes (2)
marginal adaptation
measured by Modified United States Public Health Service criteria (USPHS criteria). Score Alpha (A): no catch with explorer , Bravo (B):explorer catches , Charlie (C): explorer penetrates
Measured: immediately after restoration delivery
patient satisfaction
measure by Questionnaire (Scores are non-acceptable, acceptable, good and excellent).
Measured: immediately after restoration delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start1 Apr 2021 (estimated)
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shade MatchStudies 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
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nancy Sayed Abdel Aziz Abdel Aal Khalil, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04774614
- Sponsor's protocol ID
- 22 10 20
- Status last verified
- Feb 2021
- First submitted
- 17 Jan 2021
- Last updated
- 1 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shade Match, Marginal Adaptation and Patient Satisfaction of VITA ENAMIC multiColor Versus IPS e.Max CAD Anterior Laminate Veneers (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT04774614
- Acronym / sponsor ID
- 22 10 20
- Conditions
- Shade Match
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 1 Mar 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.
It is assumed that there will be no difference in shade match, marginal adaptation and patient satisfaction between VITA ENAMIC multiColor and IPS e.max CAD anterior laminate veneers.
Detailed description
Study settings:
This study will be carried out on patients enrolled from the Outpatient clinic in fixed prosthodontics clinic, Faculty of Oral and Dental Medicine, Cairo University.
Participant timeline:
The patient will be treated in visits designated as follows:
- st Visit: Preoperative records, face-to-face adherence reminder session, clinical, radiographic examination and primary impression for diagnostic cast construction.
- nd Visit: Teeth preparation, secondary impression and temporary restoration.
- rd Visit : Try in
- th Visit: Placement and permanent cementation of the final restoration. Shade match, marginal adaptation and patient satisfaction will be evaluated immediately after cementation
Data collection methods
Primary outcome (Shade match) will be assessed by using Modified United State Public Health Service Criteria (Modified USPHS Criteria).
Secondary outcomes:
Marginal adaptation will be assessed by modified USPHS criteria. Patient's satisfaction will be assessed using nominal scores (non-acceptable, acceptable, good and excellent).
Data management:
All data will be entered electronically in an Excel sheet. Patient files are to be stored in numerical order in a secured place.
Statistical methods:
- All Data will be collected, checked, revised, tabulated and entered into the computer.
- Data will be analyzed using IBM advance statistics (Statistics package for social sciences) version 21 (SPSS inc, Chicago, IL)
- Categorical data will be described as numbers and percentage
- Data will be explored for normality using Kolmogrov-smirnov test and Shapiro-wilk test
- Comparison between two groups for normally distributed numeric variables will be done by Mann-Whitney test. An equivalence limit will be tested.
- A P-value less than or equal to 0.05 will be considered statistically significant. All tests will be two tailed.
Data monitoring:
Monitoring The main supervisor is responsible of data monitoring if harms arise, interim analysis will be done.
Harms Any adverse effect like pain or even failure will be recorded, documented and treated.
Audit Auditing of the study design will be done by the evidence-based committee of the faculty of Oral and Dental medicine at Cairo University.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VITA ENAMIC multiColor anterior laminate veneers | Experimental | Procedure: anterior laminate veneers |
| IPS e.max CAD anterior laminate veneers | Active comparator | Procedure: anterior laminate veneers |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients aged 18-55 years, are able to read and sign the informed consent document.
- Patients who are physically and psychologically able to tolerate conventional restorative procedures.
- Patients with no active periodontal or pulpal diseases and have teeth with good restorations.
- Patients with complaints related to the esthetics in the upper or lower teeth (e.g. discoloration, fracture that does not involve more than 50% enamel loss, mild malposition)
Key exclusion criteria (4 listed)
- Patients in the growth stage with partially erupted teeth.
- Patient with fractured teeth of more than 50% enamel loss.
- Patients with poor oral hygiene.
- Patient with non-vital teeth.
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 |
|---|---|---|
| anterior laminate veneersVITA ENAMIC multiColor | Procedure or surgery | IPS e.max CAD anterior laminate veneers, VITA ENAMIC multiColor anterior laminate veneers |
Primary outcome
shade match
Time frame: immediately after restoration delivery
measured by Modified United States Public Health Service criteria (USPHS criteria). Score Alpha (A): matches tooth, Bravo (B): acceptable mismatch, Charlie (C): unacceptable mismatch
2 secondary outcomes
marginal adaptation
Time frame: immediately after restoration delivery
patient satisfaction
Time frame: immediately after restoration delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2021.
Related trials for Shade Match
Not yet recruiting
Clinical Evaluation and Patient Satisfaction of Shade Matching Between Natural Teeth and Monolithic All-ceramic Crowns Fabricated From Two Materials
Natural Optical Properties
Active, not recruiting
Evaluation of Clinical Performance, Shade Matching, and Patient Satisfaction of Different Resin Composite Layering Techniques Using 3D Printed Cast
Tooth Fractures (Class IV), Composite Resins
Recruiting
Diagnostic Accuracy of Innovative Photo-Analysis Software in Resin Composite Shade Matching
Shade Matching
Not yet recruitingObservational study
AI-Assisted Shade Selection Versus Digital Spectrophotometry in Determining Maxillary Anterior Tooth Color in a Group of Egyptian Patients at Cairo University, Faculty of Dentistry Hospital (Diagnostic Accuracy Study)
Shade Match, Shade Selection
RecruitingObservational study
Colour Match, Stability, and Patient's Satisfaction of Single-Shade Composites in Anterior Teeth
Tooth Injuries, Dental Restoration, Permanent
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.
Questions about this trial
What is this clinical trial studying?
A study testing anterior laminate veneers in people with Shade Match, run by Cairo University.
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 4 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: status not confirmed, as of the sponsor's last update on 1 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
shade match (time frame: immediately after restoration delivery). 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 1 Mar 2021.