Indirect Restoration of Badly Broken Vital TeethNCT04784676
Internal Fit Evaluation of Indirect Restorations Using Cone Beam CT (CBCT)
A study testing restoration in people with Indirect Restoration of Badly Broken Vital Teeth, run by Cairo University at 1 site in Egypt.
Trial summary
this study was conducted to evaluate the internal fit of indirect restoration fabricated from CAD/CAM composite blocks versus ceramic blocks in badly broken vital teeth using cone beam CT Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Indirect Restoration of Badly Broken Vital Teeth
- What is being tested?
- restoration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2019to 5 Apr 2020
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients with badly broken vital teeth young adult males or females (20-50 years) good oral hygeine cooperative patients approving to participate in the study
Who cannot join
- patients with acompromised medical history severe or active periodontal disease severe medical complications lack of compliance
Trial locations and contacts
1 site in 1 country.
Egypt1 site
faculty of dentistry, Cairo University
Cairo, Please Select..., 11553
About this study
Official title: Internal Fit Evaluation of Indirect Restorations Fabricated From CAD/CAM Composite Blocks Versus Ceramic Blocks in Badly Broken Teeth Using Cone Beam CT (CBCT)
this study was conducted to evaluate the internal fit of indirect restoration fabricated from CAD/CAM composite blocks versus ceramic blocks in badly broken vital teeth using cone beam CT
Read the detailed description
two parallel groups (n=42 restorations), patient having badly broken vital teeth minimum of two remaining wall will be randomly enrolled in this trial and receive restoration fabricated either from Grandio composite blocks or E-max ceramic blocks. internal fit evaluation of the fabricated restoration over their corresponding casts will be performed using cone beam CT just prior cementation of the restorations. data will be collected and statistically analyzed.
- Being tested
- restoration
- Keywords
- randomized clinical trial, internal adaptation, CAD/CAM composite restoration, all ceramic restoration, E-max CAD, CAD/CAM milling system, CAD/CAD, composite, inlays, onlays, cone beam CT, CBCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
restorationOther
indirect restoration
| Study group | Role | What they receive |
|---|---|---|
| nanohybrid composite blocks | Experimental | nanohybrid composite CAD/CAM blocks Receives: Other: restoration |
| ceramic blocks | Active comparator | ceramic CAD/CAM blocks emax Receives: Other: restoration |
What is being measured
The primary outcome is the main question the study is designed to answer.
internal fit evaluation
in millimeter
Measured: on cast before delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start1 Apr 2019
- Primary completion5 Apr 2020
- Study completion5 Apr 2020
Why it stopped: study is ended
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 Indirect Restoration of Badly Broken Vital TeethStudies 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
- Model description
- randomized clinical trial parallel group, two arms, superiority trial, allocation ratio 1:1
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shereen Hafez Ibrahim Mohamed, Cairo University
- Investigators
- Shereen H Ibrahim, PhD, Principal investigator, associate professor of conservative Dentistry, faculty of dentistry Cairo university Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04784676
- Sponsor's protocol ID
- 8-3-19
- Status last verified
- Mar 2021
- First submitted
- 3 Mar 2021
- Last updated
- 5 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ibrahim SH, Amr H, Hassan AA, Elzohairy A. Internal fit evaluation of indirect restorations fabricated from CAD/CAM composite blocks versus ceramic blocks in badly broken teeth using cone beam CT (CBCT): double-blinded randomized clinical trial. Heliyon. 2022 May 19;8(5):e09466. doi: 10.1016/j.heliyon.2022.e09466. eCollection 2022 May.
PubMed 35647344
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internal Fit Evaluation of Indirect Restorations Fabricated From CAD/CAM Composite Blocks Versus Ceramic Blocks in Badly Broken Teeth Using Cone Beam CT (CBCT)
- ClinicalTrials.gov ID
- NCT04784676
- Acronym / sponsor ID
- 8-3-19
- Keywords
- randomized clinical trial, internal adaptation, CAD/CAM composite restoration, all ceramic restoration, E-max CAD, CAD/CAM milling system, CAD/CAD, composite
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: study is ended
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 5 Apr 2020 (actual)
- Study completion
- 5 Apr 2020 (actual)
- First posted
- 5 Mar 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.
this study was conducted to evaluate the internal fit of indirect restoration fabricated from CAD/CAM composite blocks versus ceramic blocks in badly broken vital teeth using cone beam CT
Detailed description
two parallel groups (n=42 restorations), patient having badly broken vital teeth minimum of two remaining wall will be randomly enrolled in this trial and receive restoration fabricated either from Grandio composite blocks or E-max ceramic blocks. internal fit evaluation of the fabricated restoration over their corresponding casts will be performed using cone beam CT just prior cementation of the restorations. data will be collected and statistically analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized clinical trial parallel group, two arms, superiority trial, allocation ratio 1:1
| Arm | Type | Receives |
|---|---|---|
| nanohybrid composite blocks | Experimental | Other: restorationnanohybrid composite CAD/CAM blocks |
| ceramic blocks | Active comparator | Other: restorationceramic CAD/CAM blocks emax |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients with badly broken vital teeth young adult males or females (20-50 years) good oral hygeine cooperative patients approving to participate in the study
Key exclusion criteria (1 listed)
- patients with acompromised medical history severe or active periodontal disease severe medical complications lack of compliance
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 |
|---|---|---|
| restorationindirect restoration | Other | ceramic blocks, nanohybrid composite blocks |
Primary outcome
internal fit evaluation
Time frame: on cast before delivery
in millimeter
Results and safety
The study was stopped early (reason given: study is ended). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2021.
- Derived from this study: PubMed 35647344Ibrahim SH, Amr H, Hassan AA, Elzohairy A. Internal fit evaluation of indirect restorations fabricated from CAD/CAM composite blocks versus ceramic blocks in badly broken teeth using cone beam CT (CBCT): double-blinded randomized clinical trial. Heliyon. 2022 May 19;8(5):e09466. doi: 10.1016/j.heliyon.2022.e09466. eCollection 2022 May.
- 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.
Shereen H Ibrahim, PhD principal investigator
associate professor of conservative Dentistry, faculty of dentistry Cairo university Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing restoration in people with Indirect Restoration of Badly Broken Vital Teeth, 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 5 Mar 2021. 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 was stopped early (reason given: study is ended). 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?
internal fit evaluation (time frame: on cast before delivery). 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 NCT04784676, 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 5 Mar 2021.