Clinical Fit and Clinical PerformanceNCT04737005
Evaluation of Marginal, Internal Adaptation and Clinical Performance of Endo-crowns Fabricated From Nano Hybrid and Lithium Di-silicate Ceramic Materials.
A study testing Nano-ceramic hybrid (Grandio Blocs) Endo-crown in people with Clinical Fit and Clinical Performance, run by Cairo University.
Trial summary
Evaluation of the marginal and internal adaptation using silicon replica technique, which will be measured by digital microscope and clinical Performance using modified USPHS scoring system of Endo-crowns fabricated from Nano-ceramic Hybrid and Lithium di-silicate ceramic materials. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Clinical Fit and Clinical Performance
- What is being tested?
- Nano-ceramic hybrid (Grandio Blocs) Endo-crown
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2021to 1 Mar 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- From 18-50 years old, be able to read and sign the informed consent document.
- Have no active periodontal or pulpal diseases, have teeth with good restorations.
- Psychologically and physically able to withstand conventional dental procedures.
- Patients planned for a single coverage restoration in the posterior area.
- Able to return for follow-up examinations and evaluation.
- Patients have root apex of molar without evident damage and no root fracture.
- Good oral hygiene habits.
- Have a complete root canal therapy molar necessitating an Endo-crown restoration.
Who cannot join
- Patient less than 18 or more than 50 years
- Patients with severe clenching or bruxism.
- Patient with active resistant periodontal diseases
- Patients with poor oral hygiene and uncooperative patients
- Pregnant women
- Patients in the growth stage with partially erupted teeth
- Psychiatric problems or unrealistic expectations
- Patients with inadequate or low quality endodontic treatment.
About this study
Official title: Evaluation of Marginal and Internal Adaptation and Clinical Performance of Endo-crowns Fabricated From Nano-ceramic Hybrid and Lithium Di-silicate Ceramic Materials (A Randomized Controlled Clinical Trial)
Evaluation of the marginal and internal adaptation using silicon replica technique, which will be measured by digital microscope and clinical Performance using modified USPHS scoring system of Endo-crowns fabricated from Nano-ceramic Hybrid and Lithium di-silicate ceramic materials.
Read the detailed description
Evaluation of the marginal and internal adaptation using silicon replica technique, which will be measured by digital microscope and clinical Performance using modified USPHS scoring system of Endo-crowns fabricated from Nano-ceramic Hybrid and Lithium di-silicate ceramic materials.
Primary outcome: Marginal gap of the two groups will be measured using Silicon replica technique, Each replica will be sectioned bucco-lingually and mesio-distally into four segments named (MB, DB, ML, DL) and each segment has five reference points assigned at different positions, An overall of twenty reference points will be measured in each replica sample using a digital microscope.
Secondary outcome:
- Internal gap of the two groups will be measured using Silicon replica technique, which will be measured by digital microscope.
- Clinical Performance of the two groups will be evaluated using modified USPHS scoring system. (Color match, Marginal discoloration, Surface texture and Gross fracture)
- Conditions
- Clinical Fit and Clinical Performance
- Being tested
- Nano-ceramic hybrid (Grandio Blocs) Endo-crown
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nano-ceramic hybrid (Grandio Blocs) Endo-crownProcedure or surgery
Nano-ceramic hybrid
| Study group | Role | What they receive |
|---|---|---|
| Nano-ceramic hybrid (Grandio Blocs) Endo-crown. | Other | Nano-ceramic hybrid ( intervention) Receives: Procedure: Nano-ceramic hybrid (Grandio Blocs) Endo-crown |
| Lithium di-silicate Ceramic (E.max CAD blocks) Endo-crown | Active comparator | Lithium di-silicate Ceramic ( Control) Receives: Procedure: Nano-ceramic hybrid (Grandio Blocs) Endo-crown |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal and internal gap evaluation
marginal and internal gap will be evaluated by silicon replica technique, each replica will be sectioned into four segments named (MB, DB, ML, DL) and each segment had five reference points assigned at different positions, an overall of twenty reference points will be measured in each replica sample using a digital microscope. The measuring unit by microns
Measured: 1 year
Secondary outcomes (1)
clinical performance(Color match, Marginal discoloration, Surface texture and Gross fracture)
Clinical performance will be measured by modified USPHS criteria and the measuring unit by Alpha (A), Bravo (B) and Charlie (C)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start1 Feb 2021 (estimated)
- Primary completion1 Feb 2022 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical Fit and Clinical PerformanceStudies of the same condition, open and under way.
- More trials run by Cairo 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
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Salahel-din Abdel-azim, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04737005
- Sponsor's protocol ID
- 191020
- Status last verified
- Jan 2021
- First submitted
- 26 Jan 2021
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Marginal and Internal Adaptation and Clinical Performance of Endo-crowns Fabricated From Nano-ceramic Hybrid and Lithium Di-silicate Ceramic Materials (A Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT04737005
- Acronym / sponsor ID
- 191020
- Conditions
- Clinical Fit and Clinical Performance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (estimated)
- Primary completion
- 1 Feb 2022 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 3 Feb 2021 (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.
Evaluation of the marginal and internal adaptation using silicon replica technique, which will be measured by digital microscope and clinical Performance using modified USPHS scoring system of Endo-crowns fabricated from Nano-ceramic Hybrid and Lithium di-silicate ceramic materials.
Detailed description
Evaluation of the marginal and internal adaptation using silicon replica technique, which will be measured by digital microscope and clinical Performance using modified USPHS scoring system of Endo-crowns fabricated from Nano-ceramic Hybrid and Lithium di-silicate ceramic materials.
Primary outcome: Marginal gap of the two groups will be measured using Silicon replica technique, Each replica will be sectioned bucco-lingually and mesio-distally into four segments named (MB, DB, ML, DL) and each segment has five reference points assigned at different positions, An overall of twenty reference points will be measured in each replica sample using a digital microscope.
Secondary outcome:
- Internal gap of the two groups will be measured using Silicon replica technique, which will be measured by digital microscope.
- Clinical Performance of the two groups will be evaluated using modified USPHS scoring system. (Color match, Marginal discoloration, Surface texture and Gross fracture)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nano-ceramic hybrid (Grandio Blocs) Endo-crown. | Other | Procedure: Nano-ceramic hybrid (Grandio Blocs) Endo-crownNano-ceramic hybrid ( intervention) |
| Lithium di-silicate Ceramic (E.max CAD blocks) Endo-crown | Active comparator | Procedure: Nano-ceramic hybrid (Grandio Blocs) Endo-crownLithium di-silicate Ceramic ( Control) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- From 18-50 years old, be able to read and sign the informed consent document.
- Have no active periodontal or pulpal diseases, have teeth with good restorations.
- Psychologically and physically able to withstand conventional dental procedures.
- Patients planned for a single coverage restoration in the posterior area.
- Able to return for follow-up examinations and evaluation.
Key exclusion criteria (8 listed)
- Patient less than 18 or more than 50 years
- Patients with severe clenching or bruxism.
- Patient with active resistant periodontal diseases
- Patients with poor oral hygiene and uncooperative patients
- Pregnant women
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 |
|---|---|---|
| Nano-ceramic hybrid (Grandio Blocs) Endo-crownNano-ceramic hybrid | Procedure or surgery | Lithium di-silicate Ceramic (E.max CAD blocks) Endo-crown, Nano-ceramic hybrid (Grandio Blocs) Endo-crown. |
Primary outcome
Marginal and internal gap evaluation
Time frame: 1 year
marginal and internal gap will be evaluated by silicon replica technique, each replica will be sectioned into four segments named (MB, DB, ML, DL) and each segment had five reference points assigned at different positions, an overall of twenty reference points will be measured in each replica sample using a digital microscope. The measuring unit by microns
1 secondary outcome
clinical performance(Color match, Marginal discoloration, Surface texture and Gross fracture)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Individual participant dataSharing planned: Yes
Related trials for Clinical Fit and Clinical Performance
Not yet recruiting
Clinical Performance and Fit of 3D-Printed Versus Milled Endocrowns: An 18-Month Trial
Clinical Performance of Endodontically Treated Teeth Restored With Endocrowns, Restoration Fit of Endodontically Treated Teeth With Endocrowns
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.
Questions about this trial
What is this clinical trial studying?
A study testing Nano-ceramic hybrid (Grandio Blocs) Endo-crown in people with Clinical Fit and Clinical Performance, run by Cairo University.
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 8 inclusion and 8 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 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Marginal and internal gap evaluation (time frame: 1 year). 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 3 Feb 2021; AzTrials last refreshed its copy on 7 Nov 2026.