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Marginal Adaptation, Shade Matching, of Polychromatic Feldspathic VS Polychromatic Hybrid Ceramic Laminate Veneer

29 giugno 2021 aggiornato da: Kamilia Faisal Abdulkader, Cairo University

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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Anticipato)

26

Fase

  • Non applicabile

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 50 anni (Adulto)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria: All subjects are required to be:

  1. patients age range (18-50 years) old, be able to read and sign the informed consent document.
  2. Have no active periodontal or pulpal diseases, have teeth with good restorations
  3. Psychologically and physically able to withstand conventional dental procedures
  4. Patients in a need of anterior veneers.
  5. Able to return for follow-up examinations and evaluation

Exclusion Criteria:

  1. Patient less than 18 or more than 50 years
  2. Patient with active persistent periodontal diseases
  3. Patients with poor oral hygiene and uncooperative patients
  4. Patients need a smile design for the esthetic zone.
  5. Patients in the growth stage with partially erupted teeth
  6. Psychiatric problems or unrealistic expectations
  7. patient with non-vital teeth.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Multicolor feldspathic 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.
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.
Sperimentale: 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.
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Marginal adaptation
Lasso di tempo: 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
one year

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Shade matching
Lasso di tempo: one year
Modified USPHS criteria Alfa: Matches tooth (score1) Bravo: Acceptable mismatch (score2) Charlie: Unacceptable mismatch (score3)
one year
Patient satisfaction
Lasso di tempo: one year
Questionnaire (good and excellent (score1), acceptable (score2), Non-acceptable (score3)
one year

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Anticipato)

10 dicembre 2021

Completamento primario (Anticipato)

27 maggio 2024

Completamento dello studio (Anticipato)

20 novembre 2024

Date di iscrizione allo studio

Primo inviato

22 giugno 2021

Primo inviato che soddisfa i criteri di controllo qualità

22 giugno 2021

Primo Inserito (Effettivo)

28 giugno 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

1 luglio 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 giugno 2021

Ultimo verificato

1 giugno 2021

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 6221

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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