Dental RestorationNCT05501808
Color Stability of Two Different Resin Matrix Ceramics
A study testing cerasmart and enamic in people with Dental Restoration, run by Fayoum University at 1 site in Egypt.
Trial summary
This is in vivo study aimed to evaluate the color stability of the newly introduced resin ceramic matrix (cerasmart )\& (vita-enamic ) after a one year Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Dental Restoration
- What is being tested?
- cerasmart and enamic
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2021to 1 Aug 2022
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- diagnose need for restoration in endo treated posterior teeth
- good general health and oral health
- occlusal stability
Who cannot join
- smoking
- pregnancy
- use drugs that affect oral health
- Para functional habits
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry- Fayoum University
Al Fayyum, Faiyum Governorate, 63514
About this study
Official title: Color Stability of Two Different Resin Matrix Ceramics: Randomized Clinical Trial.
This is in vivo study aimed to evaluate the color stability of the newly introduced resin ceramic matrix (cerasmart )\& (vita-enamic ) after a one year
Read the detailed description
This is in vivo randomized clinical trial aimed to evaluate the color stability and patient satisfaction of the newly introduced resin ceramic matrix (cerasmart )\& (vita-enamic ) in posterior endodontically treated teeth through one year follow-up
- Conditions
- Dental Restoration
- Being tested
- cerasmart, enamic
- Keywords
- ceramics, color, stability, resin Matrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cerasmartProcedure or surgery
the patient received a crown made of cerasmart ceramic
enamicProcedure or surgery
the patient received a crown made of enamic ceramic
| Study group | Role | What they receive |
|---|---|---|
| Enamic group | Experimental | patient in this group received a restoration with enamic material Receives: Procedure: enamic |
| Cerasmart group | Active comparator | patient in this group received a restoration with Cerasmart material Receives: Procedure: cerasmart |
What is being measured
The primary outcome is the main question the study is designed to answer.
color change
measurement of restoration using digital spectrophotometer
Measured: 12 months
Secondary outcomes (1)
patient satisfaction
patient satisfaction is measured self questionnaire to patient consist of 5 questions with 4 answers each answer take a score from 1 to 5 where 1 is the patient is not satisfied at all and 5 is the patient is totally satisfied
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 posted15 Aug 2022
- Study start1 Jun 2021
- Primary completion1 Jun 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dental RestorationStudies of the same condition, open and under way.
- More trials run by Fayoum 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
- Model description
- patient with endo treated first molar
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alshaimaa Ahmed shabaan, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05501808
- Sponsor's protocol ID
- COST 315
- Status last verified
- Aug 2022
- First submitted
- 12 Aug 2022
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kanat-Erturk B. Color Stability of CAD/CAM Ceramics Prepared with Different Surface Finishing Procedures. J Prosthodont. 2020 Feb;29(2):166-172. doi: 10.1111/jopr.13019. Epub 2019 Jan 24.
PubMed 30638286Jorquera GJ, Atria PJ, Galan M, Feureisen J, Imbarak M, Kernitsky J, Cacciuttolo F, Hirata R, Sampaio CS. A comparison of ceramic crown color difference between different shade selection methods: Visual, digital camera, and smartphone. J Prosthet Dent. 2022 Oct;128(4):784-792. doi: 10.1016/j.prosdent.2020.07.029. Epub 2021 Mar 17.
PubMed 33741142Mahrous AI, Salama AA, Shabaan AA, Abdou A, Radwan MM. Color stability of two different resin matrix ceramics: randomized clinical trial. BMC Oral Health. 2023 Sep 14;23(1):665. doi: 10.1186/s12903-023-03364-6.
PubMed 37710194
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Color Stability of Two Different Resin Matrix Ceramics: Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT05501808
- Acronym / sponsor ID
- COST 315
- Conditions
- Dental Restoration
- Keywords
- ceramics, color, stability, resin Matrix
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 15 Aug 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.
This is in vivo study aimed to evaluate the color stability of the newly introduced resin ceramic matrix (cerasmart )\& (vita-enamic ) after a one year
Detailed description
This is in vivo randomized clinical trial aimed to evaluate the color stability and patient satisfaction of the newly introduced resin ceramic matrix (cerasmart )\& (vita-enamic ) in posterior endodontically treated teeth through one year follow-up
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- patient with endo treated first molar
| Arm | Type | Receives |
|---|---|---|
| Enamic group | Experimental | Procedure: enamicpatient in this group received a restoration with enamic material |
| Cerasmart group | Active comparator | Procedure: cerasmartpatient in this group received a restoration with Cerasmart material |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- diagnose need for restoration in endo treated posterior teeth
- good general health and oral health
- occlusal stability
Key exclusion criteria (4 listed)
- smoking
- pregnancy
- use drugs that affect oral health
- Para functional habits
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 |
|---|---|---|
| cerasmartthe patient received a crown made of cerasmart ceramic | Procedure or surgery | Cerasmart group |
| enamicthe patient received a crown made of enamic ceramic | Procedure or surgery | Enamic group |
Primary outcome
color change
Time frame: 12 months
measurement of restoration using digital spectrophotometer
1 secondary outcome
patient satisfaction
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 13 Mar 2025.
- Background: PubMed 30638286Kanat-Erturk B. Color Stability of CAD/CAM Ceramics Prepared with Different Surface Finishing Procedures. J Prosthodont. 2020 Feb;29(2):166-172. doi: 10.1111/jopr.13019. Epub 2019 Jan 24.
- Background: PubMed 33741142Jorquera GJ, Atria PJ, Galan M, Feureisen J, Imbarak M, Kernitsky J, Cacciuttolo F, Hirata R, Sampaio CS. A comparison of ceramic crown color difference between different shade selection methods: Visual, digital camera, and smartphone. J Prosthet Dent. 2022 Oct;128(4):784-792. doi: 10.1016/j.prosdent.2020.07.029. Epub 2021 Mar 17.
- Derived from this study: PubMed 37710194Mahrous AI, Salama AA, Shabaan AA, Abdou A, Radwan MM. Color stability of two different resin matrix ceramics: randomized clinical trial. BMC Oral Health. 2023 Sep 14;23(1):665. doi: 10.1186/s12903-023-03364-6.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cerasmart and enamic in people with Dental Restoration, run by Fayoum 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 3 inclusion and 4 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 13 Mar 2025. 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 change (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 NCT05501808, which also lists 3 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 13 Mar 2025.