Adaptation ReactionNCT04942418
Marginal Adaptation, Shade Matching, of Polychromatic Feldspathic VS Polychromatic Hybrid Ceramic Laminate Veneer
A study testing Multicolor hybrid ceramic laminate veneers. and Multicolor fieldspathic ceramic laminate veneers. in people with Adaptation Reaction and Tooth Color, run by Cairo University.
Trial summary
The aim of the present study is to evaluate the marginal adaptationو shade matching and patient satisfaction of polychromatic feldspathic porcelain laminate veneer compared to hybrid ceramic multi-color laminate veneer. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Adaptation Reaction, Tooth Color, Patient Satisfaction
- What is being tested?
- Multicolor hybrid ceramic laminate veneers. and Multicolor fieldspathic ceramic laminate veneers.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- 10 Dec 2021to 20 Nov 2024
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients age range (18-50 years) old, be able to read and sign the informed consent document.
- Have no active periodontal or pulpal diseases, have teeth with good restorations
- Psychologically and physically able to withstand conventional dental procedures
- Patients in a need of anterior veneers.
- Able to return for follow-up examinations and evaluation
Who cannot join
- Patient less than 18 or more than 50 years
- Patient with active persistent periodontal diseases
- Patients with poor oral hygiene and uncooperative patients
- Patients need a smile design for the esthetic zone.
- Patients in the growth stage with partially erupted teeth
- Psychiatric problems or unrealistic expectations
- patient with non-vital teeth.
About this study
Official title: Marginal Adaptation, Shade Matching, and Patient Satisfaction of Polychromatic Feldspathic Laminate Veneer Versus Polychromatic Hybrid Ceramic Laminate Veneer.(Randomize Control Trial)
The aim of the present study is to evaluate the marginal adaptationو shade matching and patient satisfaction of polychromatic feldspathic porcelain laminate veneer compared to hybrid ceramic multi-color laminate veneer.
Read the detailed description
PICO P: Population: patients' needs esthetic anterior veneers. I: Intervention: Multicolor hybrid ceramic laminate veneers. C: Comparison: Multicolor feldspathic laminate veneers. O: Outcome: primary: Marginal adaptation. secondary:1 Shade matching 2. Patient satisfaction. S: Study design: Randomized controlled clinical trial. T Time: One year. Research question Will polychromatic hybrid ceramic laminate veneer improve the marginal adaptation, shade matching, and patient satisfaction when compared to polychromatic feldspathic porcelain laminate veneer? Statement of the problem Anterior all-ceramic restoration exhibits esthetic challenge due to color gradient of the tooth nature from cervical to incisor, subsequently, the monochromatic CAD/CAM blocks need external stains which require more time and effort moreover it may leach out over time.
Since the feldspathic ceramic blocks display the highest translucent properties of all ceramic blocks, which make it the first choice in the esthetic zone, on the other hand, it has low strength properties that need careful handling before cementation consequently, the hybrid ceramic overcomes the brittleness characteristic of felspathic ceramics with new material that has comparable esthetic and translucency with polychromatic feature and resilience properties.
Multi-shaded blocks have recently been introducing to the market due to a lack of evidence in clinical performance evaluating marginal adaptation and shade matching of the polychromatic newly introduced blocks comparing their different color gradient. For that, the current study will directly evaluate the shade matching of feldspathic polychromatic porcelain blocks versus hybrid ceramic polychromatic blocks to enhance the multichromatic shade matching of laminate veneers restorations.
Rationale Decision-making for the treatment of esthetic areas performed to achieve highly esthetic outcomes the primary factor for achieving this goal is the material used which, should be of a high shade matching the nature color transition of the natural teeth from cervical to incisal third. Probably the new Enovation of multicolor hybrid ceramic and feldspathic porcelain will solve this problem.
Aim of the study:
The present study aims to evaluate the marginal adaptation, shade matching, and patient satisfaction of polychromatic feldspathic porcelain laminate veneer compared to hybrid ceramic multi-color laminate veneer.
Null hypothesis:
There will be no difference regarding the marginal integrity, shade matching, and patient satisfaction between multicolored feldspathic porcelain anterior laminate veneers and hybrid ceramic multi-color anterior laminate veneers.
III. Methods A) Participants, interventions, and outcomes 9- Study setting: This study will be carried out on patients enrolled from the outpatient clinic in fixed prosthodontics clinic, Faculty of Dentistry, Cairo University 10- Intervention:
10.a.i. Examination and diagnosis:
- Selection and examination of the patients according to inclusion and exclusion criteria proper scaling and polishing procedure will be done
- Primary impressions will take to produce a study cast. The patients will instruct to maintain good oral hygiene by using a toothbrush twice daily.
- Taking a pre-operative professional photo. 10.a.ii. Tooth preparation procedure:
- Recording the sulcus depth and gingival condition before preparation.
- Conservative tooth preparation will be prepared after local anesthesia has been given as required.
- Full coverage preparation will be carried out.
- After tooth preparation, adequate 2ry Impression using nonaqueous elastomeric impression materials and bite registration will be taken.
- Fabrication of the temporary restoration using composite resin temporary material and cemented using non-Eugenol Zinc Oxide temporary cement. 10.a.iii. Fabrication and cementation of restoration: Bio-HPP will be supplied in the form of discs to fabricate crown core by CAD/CAM technology then veneered with two veneering techniques; the CAD/ CAM and the manual technique using the viologen system of appropriate shade. The finished Bio HPP crown will cement with adhesive resin cement according to manufacturer instructions. 10.b. Criteria for discontinuing: Restoration will be removed when there are any signs of leakage, fracture, or severe post-operative pain due to pulpal response and replaced by a temporary restoration cemented with Ca (OH) cement to elevate pain. 10.c. Strategies to improve adherence to intervention protocol:
- ''In the first visit, a Face to Face adherence session will hold for the patient to be informed about the study steps and how to maintain oral hygiene measures.
Further sessions will occur at the follow-up visits. Participant patients will ask about any problems they are having. Patients will be recalled every three months for one year for follow-up visits.
10.d. Permitted or prohibited interventions: Oral hygiene measures are permitted for enhanced results while using hard toothbrushes or abrasive containing toothpaste after the intervention is prohibited.
11- Outcomes:
- The following assessment surveys (clinical evaluations) will be carried out for both groups: T0 = Preoperative phase: clinical records, periapical radiograph, intraoral photographs, and study casts.
T1 = immediately after final restoration delivery: intraoral photographs. T2 = postoperatively: assessment of the marginal adaptation, shade matching, and patient satisfaction.
- Conditions
- Adaptation Reaction, Tooth Color, Patient Satisfaction
- Being tested
- Multicolor hybrid ceramic laminate veneers., Multicolor fieldspathic ceramic laminate veneers.
- Keywords
- Marginal Adaptation, Shade Matching
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicolor hybrid ceramic laminate veneers.Other
Multi shaded blocks have been recently introduced to the market, due to lack of evidence in clinical performance evaluating marginal adaptation and shade matching of the polychromatic newly introduced blocks comparing their different color gradient. Multicolor hybrid ceramic laminate veneers.
Multicolor fieldspathic ceramic laminate veneers.Other
the feldspathic ceramic blocks display the highest translucent properties of all ceramic blocks which make them the first choice in the esthetic zone. esthetic and translucency with polychromatic feature and resilience properties.
| Study group | Role | What they receive |
|---|---|---|
| Multicolor feldspathic ceramic laminate veneers | Active comparator | the feldspathic ceramic blocks display the highest translucent properties of all ceramic blocks which make them the first choice in the esthetic zone. esthetic and translucency with polychromatic feature and resilience properties. Receives: Other: Multicolor fieldspathic ceramic laminate veneers. |
| Multicolor hybrid ceramic laminate veneers. | Experimental | Multi-shaded blocks have been recently introduced to the market, due to lack of evidence in clinical performance evaluating marginal adaptation and shade matching of the polychromatic newly introduced blocks comparing their different color gradient. Multicolor hybrid ceramic laminate veneers. Receives: Other: Multicolor hybrid ceramic laminate veneers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal adaptation
Modified USPHS criteria Alfa: Closely adapted (score 1), no visible crevice Bravo: Visible crevice, explorer will penetrate (score 2) Charlie: Crevice in which dentin is exposed (score3) Charlie: Crevice in which dentin is exposed
Measured: one year
Secondary outcomes (2)
Shade matching
Modified USPHS criteria Alfa: Matches tooth (score1) Bravo: Acceptable mismatch (score2) Charlie: Unacceptable mismatch (score3)
Measured: one year
Patient satisfaction
Questionnaire (good and excellent (score1), acceptable (score2), Non-acceptable (score3)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start10 Dec 2021 (estimated)
- Primary completion27 May 2024 (estimated)
- Study completion20 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adaptation ReactionStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kamilia Faisal Abdulkader, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04942418
- Sponsor's protocol ID
- 6221
- Status last verified
- Jun 2021
- First submitted
- 22 Jun 2021
- Last updated
- 1 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Marginal Adaptation, Shade Matching, and Patient Satisfaction of Polychromatic Feldspathic Laminate Veneer Versus Polychromatic Hybrid Ceramic Laminate Veneer.(Randomize Control Trial)
- ClinicalTrials.gov ID
- NCT04942418
- Acronym / sponsor ID
- 6221
- Conditions
- Adaptation Reaction, Tooth Color, Patient Satisfaction
- Keywords
- Marginal Adaptation, Shade Matching
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Dec 2021 (estimated)
- Primary completion
- 27 May 2024 (estimated)
- Study completion
- 20 Nov 2024 (estimated)
- First posted
- 28 Jun 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.
The aim of the present study is to evaluate the marginal adaptationو shade matching and patient satisfaction of polychromatic feldspathic porcelain laminate veneer compared to hybrid ceramic multi-color laminate veneer.
Detailed description
PICO P: Population: patients' needs esthetic anterior veneers. I: Intervention: Multicolor hybrid ceramic laminate veneers. C: Comparison: Multicolor feldspathic laminate veneers. O: Outcome: primary: Marginal adaptation. secondary:1 Shade matching 2. Patient satisfaction. S: Study design: Randomized controlled clinical trial. T Time: One year. Research question Will polychromatic hybrid ceramic laminate veneer improve the marginal adaptation, shade matching, and patient satisfaction when compared to polychromatic feldspathic porcelain laminate veneer? Statement of the problem Anterior all-ceramic restoration exhibits esthetic challenge due to color gradient of the tooth nature from cervical to incisor, subsequently, the monochromatic CAD/CAM blocks need external stains which require more time and effort moreover it may leach out over time.
Since the feldspathic ceramic blocks display the highest translucent properties of all ceramic blocks, which make it the first choice in the esthetic zone, on the other hand, it has low strength properties that need careful handling before cementation consequently, the hybrid ceramic overcomes the brittleness characteristic of felspathic ceramics with new material that has comparable esthetic and translucency with polychromatic feature and resilience properties.
Multi-shaded blocks have recently been introducing to the market due to a lack of evidence in clinical performance evaluating marginal adaptation and shade matching of the polychromatic newly introduced blocks comparing their different color gradient. For that, the current study will directly evaluate the shade matching of feldspathic polychromatic porcelain blocks versus hybrid ceramic polychromatic blocks to enhance the multichromatic shade matching of laminate veneers restorations.
Rationale Decision-making for the treatment of esthetic areas performed to achieve highly esthetic outcomes the primary factor for achieving this goal is the material used which, should be of a high shade matching the nature color transition of the natural teeth from cervical to incisal third. Probably the new Enovation of multicolor hybrid ceramic and feldspathic porcelain will solve this problem.
Aim of the study:
The present study aims to evaluate the marginal adaptation, shade matching, and patient satisfaction of polychromatic feldspathic porcelain laminate veneer compared to hybrid ceramic multi-color laminate veneer.
Null hypothesis:
There will be no difference regarding the marginal integrity, shade matching, and patient satisfaction between multicolored feldspathic porcelain anterior laminate veneers and hybrid ceramic multi-color anterior laminate veneers.
III. Methods A) Participants, interventions, and outcomes 9- Study setting: This study will be carried out on patients enrolled from the outpatient clinic in fixed prosthodontics clinic, Faculty of Dentistry, Cairo University 10- Intervention:
10.a.i. Examination and diagnosis:
- Selection and examination of the patients according to inclusion and exclusion criteria proper scaling and polishing procedure will be done
- Primary impressions will take to produce a study cast. The patients will instruct to maintain good oral hygiene by using a toothbrush twice daily.
- Taking a pre-operative professional photo. 10.a.ii. Tooth preparation procedure:
- Recording the sulcus depth and gingival condition before preparation.
- Conservative tooth preparation will be prepared after local anesthesia has been given as required.
- Full coverage preparation will be carried out.
- After tooth preparation, adequate 2ry Impression using nonaqueous elastomeric impression materials and bite registration will be taken.
- Fabrication of the temporary restoration using composite resin temporary material and cemented using non-Eugenol Zinc Oxide temporary cement. 10.a.iii. Fabrication and cementation of restoration: Bio-HPP will be supplied in the form of discs to fabricate crown core by CAD/CAM technology then veneered with two veneering techniques; the CAD/ CAM and the manual technique using the viologen system of appropriate shade. The finished Bio HPP crown will cement with adhesive resin cement according to manufacturer instructions. 10.b. Criteria for discontinuing: Restoration will be removed when there are any signs of leakage, fracture, or severe post-operative pain due to pulpal response and replaced by a temporary restoration cemented with Ca (OH) cement to elevate pain. 10.c. Strategies to improve adherence to intervention protocol:
- ''In the first visit, a Face to Face adherence session will hold for the patient to be informed about the study steps and how to maintain oral hygiene measures.
Further sessions will occur at the follow-up visits. Participant patients will ask about any problems they are having. Patients will be recalled every three months for one year for follow-up visits.
10.d. Permitted or prohibited interventions: Oral hygiene measures are permitted for enhanced results while using hard toothbrushes or abrasive containing toothpaste after the intervention is prohibited.
11- Outcomes:
- The following assessment surveys (clinical evaluations) will be carried out for both groups: T0 = Preoperative phase: clinical records, periapical radiograph, intraoral photographs, and study casts.
T1 = immediately after final restoration delivery: intraoral photographs. T2 = postoperatively: assessment of the marginal adaptation, shade matching, and patient satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multicolor feldspathic ceramic laminate veneers | Active comparator | Other: Multicolor fieldspathic ceramic laminate veneers.the feldspathic ceramic blocks display the highest translucent properties of all ceramic blocks which make them the first choice in the esthetic zone. esthetic and translucency with polychromatic feature and resilience properties. |
| Multicolor hybrid ceramic laminate veneers. | Experimental | Other: Multicolor hybrid ceramic laminate veneers.Multi-shaded blocks have been recently introduced to the market, due to lack of evidence in clinical performance evaluating marginal adaptation and shade matching of the polychromatic newly introduced blocks comparing their different color gradient. Multicolor hybrid ceramic laminate veneers. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- patients age range (18-50 years) old, be able to read and sign the informed consent document.
- Have no active periodontal or pulpal diseases, have teeth with good restorations
- Psychologically and physically able to withstand conventional dental procedures
- Patients in a need of anterior veneers.
- Able to return for follow-up examinations and evaluation
Key exclusion criteria (7 listed)
- Patient less than 18 or more than 50 years
- Patient with active persistent periodontal diseases
- Patients with poor oral hygiene and uncooperative patients
- Patients need a smile design for the esthetic zone.
- Patients in the growth stage with partially erupted 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 |
|---|---|---|
| Multicolor hybrid ceramic laminate veneers.Multi shaded blocks have been recently introduced to the market, due to lack of evidence in clinical performance evaluating marginal adaptation and shade matching of the polychromatic newly introduced blocks comparing their different color gradient. Multicolor hybrid ceramic laminate veneers. | Other | Multicolor hybrid ceramic laminate veneers. |
| Multicolor fieldspathic ceramic laminate veneers.the feldspathic ceramic blocks display the highest translucent properties of all ceramic blocks which make them the first choice in the esthetic zone. esthetic and translucency with polychromatic feature and resilience properties. | Other | Multicolor feldspathic ceramic laminate veneers |
Primary outcome
Marginal adaptation
Time frame: one year
Modified USPHS criteria Alfa: Closely adapted (score 1), no visible crevice Bravo: Visible crevice, explorer will penetrate (score 2) Charlie: Crevice in which dentin is exposed (score3) Charlie: Crevice in which dentin is exposed
2 secondary outcomes
Shade matching
Time frame: one year
Patient satisfaction
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2021.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Multicolor hybrid ceramic laminate veneers. and Multicolor fieldspathic ceramic laminate veneers. in people with Adaptation Reaction and Tooth Color, 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 5 inclusion and 7 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 Jul 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?
Marginal adaptation (time frame: one year). 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 Jul 2021.