NCT05437432

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 29, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

June 29, 2022

Status Verified

June 1, 2022

Enrollment Period

1.2 years

First QC Date

June 25, 2022

Last Update Submit

June 25, 2022

Conditions

Keywords

Inlay, e.max, Vita ambria, glass, cermaics, onlay, overlay

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

EXPERIMENTAL

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

Procedure: VITA AMBRIA

e.max onlay restoration

ACTIVE COMPARATOR

onlays constructed from lithium disilicate glass ceramic press system

Procedure: IPS e.max press

Interventions

VITA AMBRIAPROCEDURE

25 onlay restroations will be fabricated from Vita-ambria glass ceramic press system.

Also known as: Zirconia-reinforced lithium disilicate glass ceramic press system
Vita ambria onlay restoration

25 onlay restroations will be fabricated from IPS e.max glass ceramic press system.

Also known as: Lithium disilicate glass ceramic press system
e.max onlay restoration

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

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: 29628639BACKGROUND
  • 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.

    PMID: 33866673BACKGROUND

Related Links

MeSH Terms

Conditions

Dental CariesChromosome 2q32-Q33 Deletion Syndrome

Interventions

IPS e.max Press

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Hussein R Mohamed

    Assistant Professor of Crown and Bridge Faculty of Dental Medicine, Boys, Cairo Al-Azhar University

    STUDY DIRECTOR
  • Ahmad M El Kouedi

    Professor of Crown and Bridge Faculty of Dental Medicine, Boys, Cairo Al-Azhar University

    STUDY CHAIR

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

Locations