Esthetic Evaluation of Onlay Restorations Constructed From Vita Ambria Glass Ceramics

Not Applicable

• Conditions: Tooth Decay; Dental Caries
• Interventions: Procedure: IPS e.max press; Procedure: VITA AMBRIA

• Registration Number: NCT05437432
• Lead Sponsor: Al-Azhar University

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.

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 Timeline

• Study Start: 2022-03-01
• Status Verified: 2022-06
• Study First Submitted: 2022-06-25
• Study First Submitted QC: 2022-06-25
• Last Update Submitted: 2022-06-25
• Study First Posted: 2022-06-29
• Last Update Posted: 2022-06-29
• Primary Completion: 2023-05-01
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
e.max onlay restoration	IPS e.max press	onlays constructed from lithium disilicate glass ceramic press system
Vita ambria onlay restoration	VITA AMBRIA	onlays constructed from zirconia-reinforced lithium disilicate glass ceramic press system

Primary Outcome Measures

Name	Time	Method
Color stability and translucency	12 months	According to FDI criteria; 1. 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.; 2. Colour match is clinically acceptable but minor deviations in shade between tooth and restoration are apparent.; 3. Colour match is satisfactory; there is a clear deviation in colour match that does not affect aesthetics.; 4. 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.; 5. 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

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (1)

Faculty of Dental Medicine, Boys, Cairo Al-Azhar University; 🇪🇬 Cairo, Nasr City, Egypt