Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04942418 |
| Other study ID # |
6221 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 10, 2021 |
| Est. completion date |
November 20, 2024 |
Study information
| Verified date |
June 2021 |
| Source |
Cairo University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The aim of the present study is to evaluate the marginal adaptationŮ shade matching and
patient satisfaction of polychromatic feldspathic porcelain laminate veneer compared to
hybrid ceramic multi-color laminate veneer.
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:
1. Recording the sulcus depth and gingival condition before preparation.
2. Conservative tooth preparation will be prepared after local anesthesia has been
given as required.
3. Full coverage preparation will be carried out.
3. After tooth preparation, adequate 2ry Impression using nonaqueous elastomeric
impression materials and bite registration will be taken.
5. 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.
