Clinical trial NCT05437432: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Caries
Tooth Decay
Keywords: Inlay, e.max, Vita ambria, glass, cermaics, onlay, overlay
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2022-06-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Color stability and translucency
timeFrame: 12 months
Secondary outcomes:
measure: Surface gloss/Luster
timeFrame: 12 months
measure: Staining a. surface b. margin
timeFrame: 12 months
measure: Esthetic anatomical form
timeFrame: 12 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dental Medicine, Boys, Cairo Al-Azhar University
state: Nasr City
Study officials:
affiliation: Assistant Professor of Crown and Bridge Faculty of Dental Medicine, Boys, Cairo Al-Azhar University
name: Hussein R Mohamed
role: STUDY_DIRECTOR
affiliation: Professor of Crown and Bridge Faculty of Dental Medicine, Boys, Cairo Al-Azhar University
name: Ahmad M El Kouedi
role: STUDY_CHAIR
References:
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.
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.