Monolithic Ceramic Crowns Fabricated by Different Digital TechniquesPhase 1NCT06805604
Digital Techniques
A Phase 1 study testing Each group was received monolithic ceramic crowns fabricated using different technique in people with Monolithic Ceramic Crowns Fabricated by Different Digital Techniques, run by Faculty of Dental Medicine for Girls at 1 site in Egypt.
Trial summary
The present study is performed to evaluate clinical performance and patient satisfaction of innovative digital techniques for fabrication of monolithic ceramic crowns Read more about this study
- Who is it for?
- Ages 21 to 51 years
- Conditions the study is for
- Monolithic Ceramic Crowns Fabricated by Different Digital Techniques
- What is being tested?
- Each group was received monolithic ceramic crowns fabricated using different technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to 1 Apr 2025
- Phase
- Phase 1
- 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 21 to 51 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient with posterior molars indicated for full coverage restorations.
- Patient able to physically and psychologically tolerate conventional restorative procedures.
Who cannot join
- Patient in the growth stage with partially erupted teeth.
- Patient with poor oral hygiene and motivation.
- Patients with parafunctional habits.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
faculty of dental medicine for girls Al-Azhar university
Cairo, Egypt, 11754
About this study
Official title: Clinical Performance and Patients Satisfaction of Innovative Digital Techniques for Fabrication of Monolithic Ceramic Crowns
The present study is performed to evaluate clinical performance and patient satisfaction of innovative digital techniques for fabrication of monolithic ceramic crowns
Read the detailed description
Digital dentistry has progressed rapidly in the last few years, primarily to improve and enhance the practice of dentistry through the advancement in digital tools and techniques, providing improved accuracy and precision, enhancing patient experience, increasing efficiency and productivity, thereby resulting in better treatment outcomes, whilst also improving clinical outcomes.
- Being tested
- Each group was received monolithic ceramic crowns fabricated using different technique
- Keywords
- digital techniques
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Each group was received monolithic ceramic crowns fabricated using different techniqueProcedure or surgery
-Different digital techniques used for fabrication of the monolithic ceramic crowns were chosen for the current study, Clinical performance of all crowns regarding; marginal adaptation, fracture of restoration during service, color stability and wear behavior will be evaluated according to Modified United States Public Health Service (USPHS) Criteria at base line (1 week), 3 and 6 months after cementation of crowns.
| Study group | Role | What they receive |
|---|---|---|
| milled zirconia crowns | Experimental | this group was received milled zirconia crowns on their posterior molars indicated for full coverage restorations. Receives: Procedure: Each group was received monolithic ceramic crowns fabricated using different technique |
| milled hybrid ceramic crowns | Experimental | this group was received milled hybrid ceramic crowns on their posterior molars indicated for full coverage restorations. Receives: Procedure: Each group was received monolithic ceramic crowns fabricated using different technique |
| 3d printed hybrid ceramic crowns | Experimental | this group was received 3d printed hybrid ceramic crowns on their posterior molars indicated for full coverage restorations. Receives: Procedure: Each group was received monolithic ceramic crowns fabricated using different technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
the clinical performance, color stability and wear behavior of monolithic ceramic crowns fabricated using innovative digital techniques.
Clinical performance of all crowns regarding; marginal adaptation, fracture of restoration during service, color stability and wear behavior will be evaluated according to Modified United States Public Health Service (USPHS) Criteria at base line (1 week), 3 and 6 months after cementation of crowns.
- Color stability will be evaluated using a spectrophotometer.
- Wear of restorations will be evaluated using a software analysis.
Measured: baseline, 3months and 6 months after crown cementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start1 Oct 2024
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Monolithic Ceramic Crowns Fabricated by Different Digital TechniquesStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- study is performed on 3 groups \- Different digital techniques used for fabrication of the monolithic ceramic crowns were chosen for the current study; milled zirconia for the group (I) and milled hybrid for the group (II) and 3D-printed hybrid for the group (III).
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculty of Dental Medicine for Girls
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Eman Hafez Elfky, Faculty of Dental Medicine for Girls
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06805604
- Sponsor's protocol ID
- P-CR-23-15
- Status last verified
- Sep 2024
- First submitted
- 28 Jan 2025
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Diken Turksayar AA, Demirel M, Donmez MB, Olcay EO, Eyuboglu TF, Ozcan M. Comparison of wear and fracture resistance of additively and subtractively manufactured screw-retained, implant-supported crowns. J Prosthet Dent. 2024 Jul;132(1):154-164. doi: 10.1016/j.prosdent.2023.06.017. Epub 2023 Jul 20.
PubMed 37479623
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance and Patients Satisfaction of Innovative Digital Techniques for Fabrication of Monolithic Ceramic Crowns
- ClinicalTrials.gov ID
- NCT06805604
- Acronym / sponsor ID
- P-CR-23-15
- Keywords
- digital techniques
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Faculty of Dental Medicine for GirlsOther government
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 3 Feb 2025 (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.
The present study is performed to evaluate clinical performance and patient satisfaction of innovative digital techniques for fabrication of monolithic ceramic crowns
Detailed description
Digital dentistry has progressed rapidly in the last few years, primarily to improve and enhance the practice of dentistry through the advancement in digital tools and techniques, providing improved accuracy and precision, enhancing patient experience, increasing efficiency and productivity, thereby resulting in better treatment outcomes, whilst also improving clinical outcomes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- study is performed on 3 groups - Different digital techniques used for fabrication of the monolithic ceramic crowns were chosen for the current study; milled zirconia for the group (I) and milled hybrid for the group (II) and 3D-printed hybrid for the group (III).
| Arm | Type | Receives |
|---|---|---|
| milled zirconia crowns | Experimental | Procedure: Each group was received monolithic ceramic crowns fabricated using different techniquethis group was received milled zirconia crowns on their posterior molars indicated for full coverage restorations. |
| milled hybrid ceramic crowns | Experimental | Procedure: Each group was received monolithic ceramic crowns fabricated using different techniquethis group was received milled hybrid ceramic crowns on their posterior molars indicated for full coverage restorations. |
| 3d printed hybrid ceramic crowns | Experimental | Procedure: Each group was received monolithic ceramic crowns fabricated using different techniquethis group was received 3d printed hybrid ceramic crowns on their posterior molars indicated for full coverage restorations. |
Who may qualify
- Ages
- 21 to 51 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patient with posterior molars indicated for full coverage restorations.
- Patient able to physically and psychologically tolerate conventional restorative procedures.
Key exclusion criteria (3 listed)
- Patient in the growth stage with partially erupted teeth.
- Patient with poor oral hygiene and motivation.
- Patients with parafunctional 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 |
|---|---|---|
| Each group was received monolithic ceramic crowns fabricated using different technique-Different digital techniques used for fabrication of the monolithic ceramic crowns were chosen for the current study, Clinical performance of all crowns regarding; marginal adaptation, fracture of restoration during service, color stability and wear behavior will be evaluated according to Modified United States Public Health Service (USPHS) Criteria at base line (1 week), 3 and 6 months after cementation of crowns. | Procedure or surgery | 3d printed hybrid ceramic crowns, milled hybrid ceramic crowns, milled zirconia crowns |
Primary outcome
the clinical performance, color stability and wear behavior of monolithic ceramic crowns fabricated using innovative digital techniques.
Time frame: baseline, 3months and 6 months after crown cementation
Clinical performance of all crowns regarding; marginal adaptation, fracture of restoration during service, color stability and wear behavior will be evaluated according to Modified United States Public Health Service (USPHS) Criteria at base line (1 week), 3 and 6 months after cementation of crowns. * Color stability will be evaluated using a spectrophotometer. * Wear of restorations will be evaluated using a software analysis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Background: PubMed 37479623Diken Turksayar AA, Demirel M, Donmez MB, Olcay EO, Eyuboglu TF, Ozcan M. Comparison of wear and fracture resistance of additively and subtractively manufactured screw-retained, implant-supported crowns. J Prosthet Dent. 2024 Jul;132(1):154-164. doi: 10.1016/j.prosdent.2023.06.017. Epub 2023 Jul 20.
- Individual participant dataSharing planned: No
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 Phase 1 study testing Each group was received monolithic ceramic crowns fabricated using different technique in people with Monolithic Ceramic Crowns Fabricated by Different Digital Techniques, run by Faculty of Dental Medicine for Girls 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 3 Feb 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
the clinical performance, color stability and wear behavior of monolithic ceramic crowns fabricated using innovative digital techniques. (time frame: baseline, 3months and 6 months after crown cementation). 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 NCT06805604, which also lists 1 linked publication.
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 3 Feb 2025.