Dental CariesNCT06348979
Clinical Performance of Fiber Reinforced FRC Base and Bonded CAD/CAM Resin Composite Endocrowns
A study testing Fiber flowable (SFRC) support below hybrid nanoceramic endocrowns and all ceramic Endocrowns (emax) in people with Dental Caries, run by Cairo University at 1 site in Egypt.
Trial summary
This research proposal is introduced to clinically test short fiber reinforced flowable resin composite material (everX Flow, GC Europe) as a supporting base under CAD/CAM resin composite endocrowns due to gap of knowledge present in this area. Read more about this study
- Who is it for?
- Ages 18 to 38 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Fiber flowable (SFRC) support below hybrid nanoceramic endocrowns and all ceramic Endocrowns (emax)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 30 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 18 to 38 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Endodontically treated molar teeth indicated for endocrown.
- Presence of favorable occlusion and teeth are in normal alignment with the adjacent teeth, -medically free
Who cannot join
- ▪ Endodontically treated molar teeth indicated for post and core or only crown coverage.
- Severe periodontal problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Performance of Fiber Reinforced FRC Base and Bonded CAD/CAM Resin Composite Endocrowns Versus Conventional Lithium Disilicate Endocrowns in Posterior Teeth (1y Randomized Clinical Trial)
This research proposal is introduced to clinically test short fiber reinforced flowable resin composite material (everX Flow, GC Europe) as a supporting base under CAD/CAM resin composite endocrowns due to gap of knowledge present in this area.
- Conditions
- Dental Caries
- Being tested
- Fiber flowable (SFRC) support below hybrid nanoceramic endocrowns, all ceramic Endocrowns (emax)
- Keywords
- restoration fracture, CAD/CAM resin composite endocrowns, lithium disilicate endocrowns
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fiber flowable (SFRC) support below hybrid nanoceramic endocrownsProcedure or surgery
Also called Grandio CAD/CAM block
restoration of endodontically treated teeth by endocrowns
all ceramic Endocrowns (emax)Procedure or surgery
restoration of endodontically treated teeth by endocrowns
| Study group | Role | What they receive |
|---|---|---|
| Hybrid Nano-ceramic (Grandio) CAD/CAM Endocrowns | Experimental | Adding of short fiber reinforced flowable resin composite material (everX Flow, GC Europe) as a supporting base under CAD/CAM resin composite endocrowns Receives: Procedure: Fiber flowable (SFRC) support below hybrid nanoceramic endocrowns |
| Lithium Disilicate (e.max) Endocrowns | Active comparator | Lithium Disilicate (e.max) Endocrowns Receives: Procedure: all ceramic Endocrowns (emax) |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical Fracture
modified usphs criteria (alpha, bravo, charlie) with measuring unit: scoring system (ordinal)
Measured: change from baseline and months: 3, 6, 12
Secondary outcomes (1)
clinical performance marginal adaptation
modified usphs criteria (alpha, bravo, charlie) with measuring unit:scoring system (ordinal)
Measured: change from baseline and months: 3, 6, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start1 Jan 2022
- Primary completion30 Dec 2023
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies 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
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherifa Ahmed Abdelaziz Kandil, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06348979
- Sponsor's protocol ID
- CEBD 5/2021
- Status last verified
- Mar 2024
- First submitted
- 7 Dec 2023
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Fiber Reinforced FRC Base and Bonded CAD/CAM Resin Composite Endocrowns Versus Conventional Lithium Disilicate Endocrowns in Posterior Teeth (1y Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT06348979
- Acronym / sponsor ID
- CEBD 5/2021
- Conditions
- Dental Caries
- Keywords
- restoration fracture, CAD/CAM resin composite endocrowns, lithium disilicate endocrowns
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 5 Apr 2024 (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 research proposal is introduced to clinically test short fiber reinforced flowable resin composite material (everX Flow, GC Europe) as a supporting base under CAD/CAM resin composite endocrowns due to gap of knowledge present in this area.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hybrid Nano-ceramic (Grandio) CAD/CAM Endocrowns | Experimental | Procedure: Fiber flowable (SFRC) support below hybrid nanoceramic endocrownsAdding of short fiber reinforced flowable resin composite material (everX Flow, GC Europe) as a supporting base under CAD/CAM resin composite endocrowns |
| Lithium Disilicate (e.max) Endocrowns | Active comparator | Procedure: all ceramic Endocrowns (emax)Lithium Disilicate (e.max) Endocrowns |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Endodontically treated molar teeth indicated for endocrown.
- Presence of favorable occlusion and teeth are in normal alignment with the adjacent teeth, -medically free
Key exclusion criteria (2 listed)
- ▪ Endodontically treated molar teeth indicated for post and core or only crown coverage.
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 |
|---|---|---|
| Fiber flowable (SFRC) support below hybrid nanoceramic endocrownsAlso: Grandio CAD/CAM blockrestoration of endodontically treated teeth by endocrowns | Procedure or surgery | Hybrid Nano-ceramic (Grandio) CAD/CAM Endocrowns |
| all ceramic Endocrowns (emax)restoration of endodontically treated teeth by endocrowns | Procedure or surgery | Lithium Disilicate (e.max) Endocrowns |
Primary outcome
clinical Fracture
Time frame: change from baseline and months: 3, 6, 12
modified usphs criteria (alpha, bravo, charlie) with measuring unit: scoring system (ordinal)
1 secondary outcome
clinical performance marginal adaptation
Time frame: change from baseline and months: 3, 6, 12
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 5 Apr 2024.
- 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 Fiber flowable (SFRC) support below hybrid nanoceramic endocrowns and all ceramic Endocrowns (emax) in people with Dental Caries, run by Cairo 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 2 inclusion and 2 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 5 Apr 2024. 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?
clinical Fracture (time frame: change from baseline and months: 3, 6, 12). 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 5 Apr 2024.