Teeth RestorationPhase 1NCT04563624
Clinical Assessment of Indirect Restoration Fabricated From Nano Hybrid Composite Blocks Versus Ceramic Blocks in Badly Broken Teeth One Year Follow up
A Phase 1 study testing composite blocks and ceramic cad cam blocks in people with Teeth Restoration, run by Cairo University.
Trial summary
The aim of the study is to compare one-year clinical performance of indirect restoration fabricated from nano hybrid composite CAD CAM blocks and ceramic blocks Read more about this study
- Who is it for?
- Ages 16 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Teeth Restoration
- What is being tested?
- composite blocks and ceramic cad cam blocks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2020to 1 Nov 2021
- 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 16 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with badly broken vital teeth
- Young adult Males or female
- Good oral hygiene measures
- Cooperative patients approving to participate in the study
Who cannot join
- Patients with a compromised medical history.
- Severe or active periodontal disease
- Severe medical complications
- Lack of compliance
- Endodontically treated teeth
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Assessment Accourding to Modified Usphs"of Indirect Restoration Fabricated From Nano Hybrid Composite Blocks Versus Ceramic Blocks in Badly Broken Teeth One Year Follow up Randomized Clinical Trial
The aim of the study is to compare one-year clinical performance of indirect restoration fabricated from nano hybrid composite CAD CAM blocks and ceramic blocks
Read the detailed description
This research is conducted for comparing the clinical efficacy of nano hybrid composite blocks and ceramic blocks ., the choice of nano hybrid composite blocks based on the claim of the manufacturer, as it's considered to be promising , nano hybrid composite blocks has the highest fillers content (86% by weight), resembles natural teeth perfectly , Excellent physical values for flexural strength and abrasion, No firing required (a real one step ), can be processed using any conventional milling unit, can be finished and polished optimally, Ideal for grinding even in cases with thin edges.
- Conditions
- Teeth Restoration
- Being tested
- composite blocks, ceramic cad cam blocks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
composite blocksDrug
cad cam composite blocks
ceramic cad cam blocksDrug
ceramic cad cam blocks
| Study group | Role | What they receive |
|---|---|---|
| ceramic cad cam blocks | Experimental | Not described Receives: Drug: ceramic cad cam blocks |
| composite cad cam blocks | Active comparator | Not described Receives: Drug: composite blocks |
What is being measured
The primary outcome is the main question the study is designed to answer.
marginal integrity
using usphs visual inspection
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start1 Oct 2020 (estimated)
- Primary completion1 Nov 2020 (estimated)
- Study completion1 Nov 2021 (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 Teeth RestorationStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haneen ahmed shafik elmoselhy, British University In Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04563624
- Sponsor's protocol ID
- 13919991
- Status last verified
- Sep 2020
- First submitted
- 20 Sep 2020
- Last updated
- 28 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Elmoselhy HAS, Hassanien OES, Haridy MF, Salam El Baz MAE, Saber S. Two-year clinical performance of indirect restorations fabricated from CAD/CAM nano hybrid composite versus lithium disilicate in mutilated vital teeth. A randomized controlled trial. BMC Oral Health. 2024 Jan 17;24(1):101. doi: 10.1186/s12903-023-03847-6.
PubMed 38233771
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment Accourding to Modified Usphs"of Indirect Restoration Fabricated From Nano Hybrid Composite Blocks Versus Ceramic Blocks in Badly Broken Teeth One Year Follow up Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04563624
- Acronym / sponsor ID
- 13919991
- Conditions
- Teeth Restoration
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 1 Nov 2020 (estimated)
- Study completion
- 1 Nov 2021 (estimated)
- First posted
- 24 Sep 2020 (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 aim of the study is to compare one-year clinical performance of indirect restoration fabricated from nano hybrid composite CAD CAM blocks and ceramic blocks
Detailed description
This research is conducted for comparing the clinical efficacy of nano hybrid composite blocks and ceramic blocks ., the choice of nano hybrid composite blocks based on the claim of the manufacturer, as it's considered to be promising , nano hybrid composite blocks has the highest fillers content (86% by weight), resembles natural teeth perfectly , Excellent physical values for flexural strength and abrasion, No firing required (a real one step ), can be processed using any conventional milling unit, can be finished and polished optimally, Ideal for grinding even in cases with thin edges.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ceramic cad cam blocks | Experimental | Drug: ceramic cad cam blocks |
| composite cad cam blocks | Active comparator | Drug: composite blocks |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with badly broken vital teeth
- Young adult Males or female
- Good oral hygiene measures
- Cooperative patients approving to participate in the study
Key exclusion criteria (5 listed)
- Patients with a compromised medical history.
- Severe or active periodontal disease
- Severe medical complications
- Lack of compliance
- Endodontically treated teeth
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 |
|---|---|---|
| composite blockscad cam composite blocks | Drug | composite cad cam blocks |
| ceramic cad cam blocksceramic cad cam blocks | Drug | ceramic cad cam blocks |
Primary outcome
marginal integrity
Time frame: one year
using usphs visual inspection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2020.
- Derived from this study: PubMed 38233771Elmoselhy HAS, Hassanien OES, Haridy MF, Salam El Baz MAE, Saber S. Two-year clinical performance of indirect restorations fabricated from CAD/CAM nano hybrid composite versus lithium disilicate in mutilated vital teeth. A randomized controlled trial. BMC Oral Health. 2024 Jan 17;24(1):101. doi: 10.1186/s12903-023-03847-6.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing composite blocks and ceramic cad cam blocks in people with Teeth Restoration, 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 4 inclusion and 5 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 28 Sep 2020. 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.
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?
Contact HANEEN ELMOSELHY, mastrers (01003778829, haneen.elmoselhy@bue.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
marginal integrity (time frame: one year). 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 NCT04563624, 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 28 Sep 2020.