Artificial IntelligenceNCT06164002
A I in the Prediction of Clinical Performance, Marginal Fit and Fracture Resistance of Vertical Versus Horizontal Margin Designs Fabricated With 2 Ceramic Materials
A study testing change in restoration material and margin design. in people with Artificial Intelligence, run by Faculty of Dental Medicine for Girls at 1 site in Egypt.
Trial summary
The present study will be performed to evaluate application of artificial intelligence in the prediction of clinical performance, marginal fit and fracture resistance of vertical "feather-edge" versus horizontal "shoulder" margin designs fabricated with two ceramic materials (zirconia and hybrid ceramic) Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Artificial Intelligence
- What is being tested?
- change in restoration material and margin design.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2023to 15 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1. Age range of patients should be 20-50 years old, able to read and sign the informed consent document. 2. Patient with posterior molars indicated for full coverage restorations. 3. Patient should be able to physically and psychologically tolerate conventional restorative procedures. 4. Patients who are willing to return for follow-up examination and evaluation. 5. Indicated molar should have adequate tooth preparation length to ensure proper retention and resistance form. 6. Patient with sound contralateral or adjacent tooth to the selected tooth requiring full coverage restoration.
Who cannot join
- Patient in the growth stage with partially erupted teeth.
- Patient with poor oral hygiene and motivation.
- Pregnant women.
- Patient with psychiatric problems or unrealistic expectations.
- Patients with no opposing occluding dentition in the area intended for restoration.
- Patients with parafunctional habits. -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Application of Artificial Intelligence in the Prediction of Clinical Performance, Marginal Fit and Fracture Resistance of Vertical Versus Horizontal Margin Designs Fabricated With Two Ceramic Materials
The present study will be performed to evaluate application of artificial intelligence in the prediction of clinical performance, marginal fit and fracture resistance of vertical "feather-edge" versus horizontal "shoulder" margin designs fabricated with two ceramic materials (zirconia and hybrid ceramic)
Read the detailed description
The objective of the present study is to characterize two different margin designs (vertical "feather-edge" and horizontal "shoulder") with two different ceramic materials (zirconia and hybrid ceramic) in terms of clinical performance, marginal fit and fracture resistance.
Primary outcome:
Predicting the follow up results using the new (artificial intelligence "AI") model for vertical "feather-edge" versus horizontal "shoulder" margin designs fabricated with two ceramic materials (zirconia and hybrid ceramic) that saves the clinical evaluation period, hence saves the expenses of the dental clinic.
Secondary outcome:
Evaluating the clinical performance, marginal fit and fracture resistance of vertical "feather-edge" versus horizontal "shoulder" margin designs fabricated with two ceramic materials (zirconia and hybrid ceramic).
- Conditions
- Artificial Intelligence
- Being tested
- change in restoration material and margin design.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
change in restoration material and margin design.Other
Also called Predicting the follow up results using the new (artificial intelligence "AI") model
comparing two different materials and two different designs. use artificial intelligence in the prediction of follow up results
| Study group | Role | What they receive |
|---|---|---|
| Group (I) | Experimental | Patients will be prepared with vertical "feather edge" margin design. Receives: Other: change in restoration material and margin design. |
| Group (II) | Experimental | Patients will be prepared with horizontal "shoulder" margin design. Receives: Other: change in restoration material and margin design. |
| Subgroup (A) | Experimental | Patients will receive zirconia ceramic crowns Receives: Other: change in restoration material and margin design. |
| Subgroup (B) | Experimental | Patients will receive hybrid ceramic crowns. Receives: Other: change in restoration material and margin design. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Artificial intelligence application assessment, laboratory marginal fit and fracture resistance
Predicting the follow up results using the new (artificial intelligence "AI") model for vertical "feather-edge" versus horizontal "shoulder" margin designs fabricated with two ceramic materials (zirconia and hybrid ceramic) that saves the clinical evaluation period, hence saves the expenses of the dental clinic.
Measured: 6 months
Secondary outcomes (3)
In-Vitro Study preparations.
Marginal Adaptation "feather-edge" versus horizontal "shoulder" margin designs fabricated with two ceramic materials (zirconia and hybrid ceramic).
Measured: 6 months
In-Vitro Study
Fracture Resistance
Measured: 6 months
In-Vivo Study
Clinical Examination
Measured: Baseline,3 months,6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start1 Sep 2023
- Primary completion15 Sep 2024
- Study completion15 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Artificial IntelligenceStudies 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Faculty of Dental Medicine for Girls
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Walaa Tarek Mohamed, Faculty of Dental Medicine for Girls
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06164002
- Sponsor's protocol ID
- P-CR-23-04
- Status last verified
- Feb 2025
- First submitted
- 16 Aug 2023
- Last updated
- 6 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Artificial Intelligence in the Prediction of Clinical Performance, Marginal Fit and Fracture Resistance of Vertical Versus Horizontal Margin Designs Fabricated With Two Ceramic Materials
- ClinicalTrials.gov ID
- NCT06164002
- Acronym / sponsor ID
- P-CR-23-04
- Conditions
- Artificial Intelligence
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Faculty of Dental Medicine for GirlsOther government
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 15 Sep 2024 (actual)
- Study completion
- 15 May 2025 (estimated)
- First posted
- 11 Dec 2023 (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 will be performed to evaluate application of artificial intelligence in the prediction of clinical performance, marginal fit and fracture resistance of vertical "feather-edge" versus horizontal "shoulder" margin designs fabricated with two ceramic materials (zirconia and hybrid ceramic)
Detailed description
The objective of the present study is to characterize two different margin designs (vertical "feather-edge" and horizontal "shoulder") with two different ceramic materials (zirconia and hybrid ceramic) in terms of clinical performance, marginal fit and fracture resistance.
Primary outcome:
Predicting the follow up results using the new (artificial intelligence "AI") model for vertical "feather-edge" versus horizontal "shoulder" margin designs fabricated with two ceramic materials (zirconia and hybrid ceramic) that saves the clinical evaluation period, hence saves the expenses of the dental clinic.
Secondary outcome:
Evaluating the clinical performance, marginal fit and fracture resistance of vertical "feather-edge" versus horizontal "shoulder" margin designs fabricated with two ceramic materials (zirconia and hybrid ceramic).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group (I) | Experimental | Other: change in restoration material and margin design.Patients will be prepared with vertical "feather edge" margin design. |
| Group (II) | Experimental | Other: change in restoration material and margin design.Patients will be prepared with horizontal "shoulder" margin design. |
| Subgroup (A) | Experimental | Other: change in restoration material and margin design.Patients will receive zirconia ceramic crowns |
| Subgroup (B) | Experimental | Other: change in restoration material and margin design.Patients will receive hybrid ceramic crowns. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1. Age range of patients should be 20-50 years old, able to read and sign the informed consent document. 2. Patient with posterior molars indicated for full coverage restorations. 3. Patient should be able to physically and psychologically tolerate conventional restorative procedures. 4. Patients who are willing to return for follow-up examination and evaluation. 5. Indicated molar should have adequate tooth preparation length to ensure proper retention and resistance form. 6. Patient with sound contralateral or adjacent tooth to the selected tooth requiring full coverage restoration.
Key exclusion criteria (6 listed)
- Patient in the growth stage with partially erupted teeth.
- Patient with poor oral hygiene and motivation.
- Pregnant women.
- Patient with psychiatric problems or unrealistic expectations.
- Patients with no opposing occluding dentition in the area intended for restoration.
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 |
|---|---|---|
| change in restoration material and margin design.Also: Predicting the follow up results using the new (artificial intelligence "AI") modelcomparing two different materials and two different designs. use artificial intelligence in the prediction of follow up results | Other | Group (I), Group (II), Subgroup (A), Subgroup (B) |
Primary outcome
Artificial intelligence application assessment, laboratory marginal fit and fracture resistance
Time frame: 6 months
Predicting the follow up results using the new (artificial intelligence "AI") model for vertical "feather-edge" versus horizontal "shoulder" margin designs fabricated with two ceramic materials (zirconia and hybrid ceramic) that saves the clinical evaluation period, hence saves the expenses of the dental clinic.
3 secondary outcomes
In-Vitro Study preparations.
Time frame: 6 months
In-Vitro Study
Time frame: 6 months
In-Vivo Study
Time frame: Baseline,3 months,6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- 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 change in restoration material and margin design. in people with Artificial Intelligence, 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 1 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 6 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Artificial intelligence application assessment, laboratory marginal fit and fracture resistance (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Feb 2025.