Dental CariesNCT05437432
Esthetic Evaluation of Onlay Restorations Constructed From Vita Ambria Glass Ceramics
A study testing VITA AMBRIA and IPS e.max press in people with Dental Caries, run by Al-Azhar University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- VITA AMBRIA and IPS e.max press
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2022to 1 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy participants aged 18-50 years
- Normal occlusion
- Well-aligned teeth
- Good oral hygiene
- Both sexes eligible
- Presence of one or more posterior teeth with moderate-size coronal decay or old fillings
Show all 10Show fewer
- Target teeth:
- No signs/symptoms of pathology
- Complete root apex (confirmed by radiograph)
- No fractures (confirmed by radiograph)
Who cannot join
- Incapable of self-care
- Mental illness
- Undergoing radiotherapy
- Epilepsy
- Diabetes
- Pregnancy or lactation
Show all 17Show fewer
- Allergy to materials used in the study
- Smokers
- Parafunctional habits (e.g., bruxism)
- Poor oral hygiene
- Severe periodontitis
- Teeth requiring surgical crown lengthening or marginal elevation
- Teeth with enamel discoloration, hypoplasia, or hypocalcification
- Malaligned or malformed teeth
- Missing adjacent or opposing teeth
- Third molars
- Teeth requiring vital pulp therapy
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dental Medicine, Boys, Cairo Al-Azhar University
Cairo, Nasr City, 11768
About this study
Official title: Esthetic Evaluation of Onlay Restorations Constructed From Two Types of Glass Ceramics:A Randomized Clinical Trial.
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.
Read the 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.
- Conditions
- Dental Caries
- Being tested
- VITA AMBRIA, IPS e.max press
- Keywords
- Inlay, glass cermaics, color, Translucency
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VITA AMBRIAProcedure or surgery
Also called Zirconia-reinforced lithium disilicate glass ceramic press system
25 onlay restroations will be fabricated from Vita-ambria glass ceramic press system.
IPS e.max pressProcedure or surgery
Also called Lithium disilicate glass ceramic press system
25 onlay restroations will be fabricated from IPS e.max glass ceramic press system.
| Study group | Role | What they receive |
|---|---|---|
| Vita ambria onlay restoration | Experimental | onlays constructed from zirconia-reinforced lithium disilicate glass ceramic press system Receives: Procedure: VITA AMBRIA |
| e.max onlay restoration | Active comparator | onlays constructed from lithium disilicate glass ceramic press system Receives: Procedure: IPS e.max press |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (3)
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start1 Mar 2022
- Primary completion1 May 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrahman Mohammed Abdelhameed, Al-Azhar University
- Investigators
- Hussein R Mohamed, Study director, Assistant Professor of Crown and Bridge Faculty of Dental Medicine, Boys, Cairo Al-Azhar UniversityAhmad M El Kouedi, Study chair, Professor of Crown and Bridge Faculty of Dental Medicine, Boys, Cairo Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05437432
- Sponsor's protocol ID
- Color of Vita Ambria
- Status last verified
- Oct 2026
- First submitted
- 25 Jun 2022
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29628639Pop-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.
PubMed 33866673
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esthetic Evaluation of Onlay Restorations Constructed From Two Types of Glass Ceramics:A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT05437432
- Acronym / sponsor ID
- Color of Vita Ambria
- Conditions
- Dental Caries
- Keywords
- Inlay, glass cermaics, color, Translucency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 29 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vita ambria onlay restoration | Experimental | Procedure: VITA AMBRIAonlays constructed from zirconia-reinforced lithium disilicate glass ceramic press system |
| e.max onlay restoration | Active comparator | Procedure: IPS e.max pressonlays constructed from lithium disilicate glass ceramic press system |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Healthy participants aged 18-50 years
- Normal occlusion
- Well-aligned teeth
- Good oral hygiene
- Both sexes eligible
Key exclusion criteria (17 listed)
- Incapable of self-care
- Mental illness
- Undergoing radiotherapy
- Epilepsy
- Diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VITA AMBRIAAlso: Zirconia-reinforced lithium disilicate glass ceramic press system25 onlay restroations will be fabricated from Vita-ambria glass ceramic press system. | Procedure or surgery | Vita ambria onlay restoration |
| IPS e.max pressAlso: Lithium disilicate glass ceramic press system25 onlay restroations will be fabricated from IPS e.max glass ceramic press system. | Procedure or surgery | e.max onlay restoration |
Primary outcome
Color stability and translucency
Time frame: 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.
3 secondary outcomes
Surface gloss/Luster
Time frame: 12 months
Staining a. surface b. margin
Time frame: 12 months
Esthetic anatomical form
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Background: PubMed 29628639Azeem 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.
- Background: PubMed 33866673Pop-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.
- Clinical performance of direct versus indirect composite restorations in posterior teeth: A systematic reviewLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hussein R Mohamed study director
Assistant Professor of Crown and Bridge Faculty of Dental Medicine, Boys, Cairo Al-Azhar University
Ahmad M El Kouedi study chair
Professor of Crown and Bridge Faculty of Dental Medicine, Boys, Cairo Al-Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VITA AMBRIA and IPS e.max press in people with Dental Caries, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Color stability and translucency (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05437432, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.