Esthetic Evaluation of Onlay Restorations Constructed From Vita Ambria Glass Ceramics
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2022
CompletedFirst Submitted
Initial submission to the registry
June 25, 2022
CompletedFirst Posted
Study publicly available on registry
June 29, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedJune 29, 2022
June 1, 2022
1.2 years
June 25, 2022
June 25, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Color stability and translucency
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.
12 months
Secondary Outcomes (3)
Surface gloss/Luster
12 months
Staining a. surface b. margin
12 months
Esthetic anatomical form
12 months
Study Arms (2)
Vita ambria onlay restoration
EXPERIMENTALonlays constructed from zirconia-reinforced lithium disilicate glass ceramic press system
e.max onlay restoration
ACTIVE COMPARATORonlays constructed from lithium disilicate glass ceramic press system
Interventions
25 onlay restroations will be fabricated from Vita-ambria glass ceramic press system.
25 onlay restroations will be fabricated from IPS e.max glass ceramic press system.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Dental Medicine, Boys, Cairo Al-Azhar University
Cairo, Nasr City, 11768, Egypt
Related Publications (2)
Azeem RA, Sureshbabu NM. Clinical performance of direct versus indirect composite restorations in posterior teeth: A systematic review. J Conserv Dent. 2018 Jan-Feb;21(1):2-9. doi: 10.4103/JCD.JCD_213_16.
PMID: 29628639BACKGROUNDPop-Ciutrila IS, Ghinea R, Dudea D, Ruiz-Lopez J, Perez MM, Colosi H. The effects of thickness and shade on translucency parameters of contemporary, esthetic dental ceramics. J Esthet Restor Dent. 2021 Jul;33(5):795-806. doi: 10.1111/jerd.12733. Epub 2021 Apr 18.
PMID: 33866673BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant lecturer
Study Record Dates
First Submitted
June 25, 2022
First Posted
June 29, 2022
Study Start
March 1, 2022
Primary Completion
May 1, 2023
Study Completion
June 1, 2023
Last Updated
June 29, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share