Esthetic Evaluation of Onlay Restorations Constructed From Vita Ambria Glass Ceramics

Sponsor
Al-Azhar University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05437432
Collaborator
(none)
50
1
2
15
3.3

Study Details

Study Description

Brief Summary

There is limited data available on VITA AMBRIA glass ceramic , so this study is conducted to investigate the esthetic parameters of this new glass press system.

Condition or Disease Intervention/Treatment Phase
  • Procedure: VITA AMBRIA
  • Procedure: IPS e.max press
N/A

Detailed Description

This study will be randomized, double blinded, 1:1 parallel group, superiority clinical trial. including two research groups; VITA AMBRIA ( intervention) and IPS e.max press( Comprator). The total subjects in this study are 50, recruited from the faculty' out patient clinic. 50 partial coverage indirect restorations will fabricated and cemented for each subject. Clinical evaluations will be conducted at baseline, 6, and 12 months of follow-up according to FDI World Dental Federation criteria by two independent evaluators. The primary outcome is examining the color stability and translucency.

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Esthetic Evaluation of Onlay Restorations Constructed From Two Types of Glass Ceramics:A Randomized Clinical Trial.
Actual Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Vita ambria onlay restoration

onlays constructed from zirconia-reinforced lithium disilicate glass ceramic press system

Procedure: VITA AMBRIA
25 onlay restroations will be fabricated from Vita-ambria glass ceramic press system.
Other Names:
  • Zirconia-reinforced lithium disilicate glass ceramic press system
  • Active Comparator: e.max onlay restoration

    onlays constructed from lithium disilicate glass ceramic press system

    Procedure: IPS e.max press
    25 onlay restroations will be fabricated from IPS e.max glass ceramic press system.
    Other Names:
  • Lithium disilicate glass ceramic press system
  • Outcome Measures

    Primary Outcome Measures

    1. Color stability and translucency [12 months]

      According to FDI criteria; Color and translucency of the restoration have a clinically excellent colour match with the surrounding enamel and adjacent teeth. There is no difference in shade, brightness or translucency between restoration and tooth. Colour match is clinically acceptable but minor deviations in shade between tooth and restoration are apparent. Colour match is satisfactory; there is a clear deviation in colour match that does not affect aesthetics. Colour and/or translucency are clinically unsatisfactory. There is a localized discoloration or opaqueness in the restoration making it immediately recognizable from a speaking distance and affecting the appearance of the dentition. Partial removal and repair are possible. Colour match and/or translucency. are clinically unsatisfactory. The restoration displays an unacceptable alteration in colour and/or translucency. Restoration needs replacement.

    Secondary Outcome Measures

    1. Surface gloss/Luster [12 months]

      1.1 Luster comparable to enamel. 1.2.1 Slightly dull, not noticeable from speaking distance. 1.2.2 Some isolated pores. 1.3.1 Dull surface but acceptable if covered with film of saliva. 1.3.2 Multiple pores on more than one third of the surface. 1.4.1 Rough surface cannot be masked by saliva film, simple polishing is not sufficient. Further intervention necessary. 1.4.2 Voids. 1.5 Very rough, unacceptable plaque retentive surface.

    2. Staining a. surface b. margin [12 months]

      2a.1 No surface staining. 2b.1 No marginal staining. 2a.2 Minor surface staining, easily removable by polishing. 2b.2 Minor marginal staining, easily removable by polishing. 2a.3 Moderate surface staining that may also present on other teeth, not esthetically unacceptable. 2b.3 Moderate marginal staining, not esthetically unacceptable. 2a.4 Unacceptable surface staining on the restoration and major intervention necessary for improvement. 2b.4 Pronounced marginal staining; major intervention necessary for improvement. 2a.5 Severe surface staining and/or subsurface staining, generalized or localized, not accessible for intervention. 2b.5 Deep marginal staining, not accessible for intervention.

    3. Esthetic anatomical form [12 months]

      4.1 Form is ideal. 4.2 Form is only slightly deviated from the normal. 4.3 Form deviates from the normal but is esthetically acceptable. 4.4. Form is affected and unacceptable esthetically. Intervention/correction is necessary. 4.5 Form is unsatisfactory and/or lost. Repair not feasible / reasonable, Replacement needed.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    Participants in this trial should be Healthy, between 18-50 years old, have normal occlusion, well aligned teeth, and good oral hygiene. Both sexes will be included. Participants should present with one or more of their posterior teeth having moderate-size coronal decay or old filling. The target teeth should be free from any signs and symptoms and should have complete root apex with no fracture as determined by the radiograph.

    Exclusion Criteria:

    Incapable of self-care, mental illness, undergoing radiotherapy, epilepsy, diabetic patient, pregnancy, allergy to one of the materials used, smokers, parafunctional habits, poor oral hygiene, severe periodontitis, teeth need surgical crown lengthening or marginal elevation, teeth with enamel discoloration or enamel/dentin hypoplasia or hypocalcification, Malaligned or malformed teeth and adjacent or opposing teeth are missed. Third molars and teeth need vital pulp therapy will also be excluded.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Dental Medicine, Boys, Cairo Al-Azhar University Cairo Nasr City Egypt 11768

    Sponsors and Collaborators

    • Al-Azhar University

    Investigators

    • Study Director: Hussein R Mohamed, Assistant Professor of Crown and Bridge Faculty of Dental Medicine, Boys, Cairo Al-Azhar University
    • Study Chair: Ahmad M El Kouedi, Professor of Crown and Bridge Faculty of Dental Medicine, Boys, Cairo Al-Azhar University

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Abdelrahman Mohammed Abdelhameed, Assistant lecturer, Al-Azhar University
    ClinicalTrials.gov Identifier:
    NCT05437432
    Other Study ID Numbers:
    • Color of Vita Ambria
    First Posted:
    Jun 29, 2022
    Last Update Posted:
    Jun 29, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Abdelrahman Mohammed Abdelhameed, Assistant lecturer, Al-Azhar University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 29, 2022