Back to resultsEsthetic Evaluation of Onlay Restorations Constructed From Vita Ambria Glass Ceramics
Primary Purpose
Dental Caries, Tooth Decay
Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
VITA AMBRIA
IPS e.max press
Sponsored by
About this trial
This is an interventional treatment trial for Dental Caries focused on measuring Inlay, e.max, Vita ambria, glass, cermaics, onlay, overlay
Eligibility Criteria
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.
Sites / Locations
- Faculty of Dental Medicine, Boys, Cairo Al-Azhar University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Vita ambria onlay restoration
e.max onlay restoration
Arm Description
onlays constructed from zirconia-reinforced lithium disilicate glass ceramic press system
onlays constructed from lithium disilicate glass ceramic press system
Outcomes
Primary Outcome Measures
Color stability and translucency
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
Surface gloss/Luster
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.
Staining a. surface b. margin
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.
Esthetic anatomical form
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05437432
Brief Title
Esthetic Evaluation of Onlay Restorations Constructed From Vita Ambria Glass Ceramics
Official Title
Esthetic Evaluation of Onlay Restorations Constructed From Two Types of Glass Ceramics:A Randomized Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries, Tooth Decay
Keywords
Inlay, e.max, Vita ambria, glass, cermaics, onlay, overlay
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vita ambria onlay restoration
Arm Type
Experimental
Arm Description
onlays constructed from zirconia-reinforced lithium disilicate glass ceramic press system
Arm Title
e.max onlay restoration
Arm Type
Active Comparator
Arm Description
onlays constructed from lithium disilicate glass ceramic press system
Intervention Type
Procedure
Intervention Name(s)
VITA AMBRIA
Other Intervention Name(s)
Zirconia-reinforced lithium disilicate glass ceramic press system
Intervention Description
25 onlay restroations will be fabricated from Vita-ambria glass ceramic press system.
Intervention Type
Procedure
Intervention Name(s)
IPS e.max press
Other Intervention Name(s)
Lithium disilicate glass ceramic press system
Intervention Description
25 onlay restroations will be fabricated from IPS e.max glass ceramic press system.
Primary Outcome Measure Information:
Title
Color stability and translucency
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Surface gloss/Luster
Description
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.
Time Frame
12 months
Title
Staining a. surface b. margin
Description
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.
Time Frame
12 months
Title
Esthetic anatomical form
Description
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hussein R Mohamed
Organizational Affiliation
Assistant Professor of Crown and Bridge Faculty of Dental Medicine, Boys, Cairo Al-Azhar University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ahmad M El Kouedi
Organizational Affiliation
Professor of Crown and Bridge Faculty of Dental Medicine, Boys, Cairo Al-Azhar University
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of Dental Medicine, Boys, Cairo Al-Azhar University
City
Cairo
State/Province
Nasr City
ZIP/Postal Code
11768
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29628639
Citation
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.
Results Reference
background
PubMed Identifier
33866673
Citation
Pop-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.
Results Reference
background
Links:
URL
https://www.jcd.org.in/article.asp?issn=0972-0707;year=2018;volume=21;issue=1;spage=2;epage=9;aulast=Azeem
Description
Clinical performance of direct versus indirect composite restorations in posterior teeth: A systematic review
Learn more about this trial
Esthetic Evaluation of Onlay Restorations Constructed From Vita Ambria Glass Ceramics
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