Premolars Need Full Coverage RestorationNCT03303742
Feather Edge Versus Deep Chamfer Finish Line Marginal Design in Complete Coverage Bruxzir Zirconia Crowns
A study testing deep chamfer and feather edge in people with Premolars Need Full Coverage Restoration, run by Cairo University at 1 site in Egypt.
Trial summary
Evaluation of patient satisfaction, color difference, marginal integrity and survival of Bruxzir Zirconia complete coverage crowns with feather edge versus deep chamfer finish line marginal design. (Randomised Controlled Trial) Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Premolars Need Full Coverage Restoration
- What is being tested?
- deep chamfer and feather edge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Feb 2021to 30 Sep 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 19 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 19-50 years.
- Males or females.
- Co-operative patients approving to participate in the trial.
Who cannot join
- Patients younger than 19 years old
- Disabilities
- Systemic diseases or severe medically compromised
- Lack of compliance of the patient contributed in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Patient Satisfaction, Color Difference, Marginal Integrity and Survival of Bruxzir Zirconia Complete Coverage Crowns With Feather Edge Versus Deep Chamfer Finish Line Marginal Design.
Evaluation of patient satisfaction, color difference, marginal integrity and survival of Bruxzir Zirconia complete coverage crowns with feather edge versus deep chamfer finish line marginal design.
(Randomised Controlled Trial)
- Conditions
- Premolars Need Full Coverage Restoration
- Being tested
- deep chamfer, feather edge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
deep chamferOther
Also called rounded shoulder
finish line marginal design of a full coverage crown preparation
feather edgeOther
Also called knife edge
finish line marginal design of a full coverage crown preparation
| Study group | Role | What they receive |
|---|---|---|
| feather edge finish line marginal design | Experimental | intervention Receives: Other: feather edge |
| deep chamfer finish line marginal design | Active comparator | comparator Receives: Other: deep chamfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient satisfaction
patient satisfaction will be measured by questionnaire
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 posted6 Oct 2017
- Study start10 Feb 2021
- Primary completion10 Aug 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premolars Need Full Coverage 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Elbasha, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03303742
- Sponsor's protocol ID
- CEBD-CU-2017-10-03
- Status last verified
- Jul 2022
- First submitted
- 3 Oct 2017
- Last updated
- 22 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Patient Satisfaction, Color Difference, Marginal Integrity and Survival of Bruxzir Zirconia Complete Coverage Crowns With Feather Edge Versus Deep Chamfer Finish Line Marginal Design.
- ClinicalTrials.gov ID
- NCT03303742
- Acronym / sponsor ID
- CEBD-CU-2017-10-03
- Conditions
- Premolars Need Full Coverage Restoration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Feb 2021 (actual)
- Primary completion
- 10 Aug 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 6 Oct 2017 (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 patient satisfaction, color difference, marginal integrity and survival of Bruxzir Zirconia complete coverage crowns with feather edge versus deep chamfer finish line marginal design.
(Randomised Controlled Trial)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| feather edge finish line marginal design | Experimental | Other: feather edgeintervention |
| deep chamfer finish line marginal design | Active comparator | Other: deep chamfercomparator |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 19-50 years.
- Males or females.
- Co-operative patients approving to participate in the trial.
Key exclusion criteria (4 listed)
- Patients younger than 19 years old
- Disabilities
- Systemic diseases or severe medically compromised
- Lack of compliance of the patient contributed in the study
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 |
|---|---|---|
| deep chamferAlso: rounded shoulderfinish line marginal design of a full coverage crown preparation | Other | deep chamfer finish line marginal design |
| feather edgeAlso: knife edgefinish line marginal design of a full coverage crown preparation | Other | feather edge finish line marginal design |
Primary outcome
patient satisfaction
Time frame: one year
patient satisfaction will be measured by questionnaire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
- Individual participant dataSharing planned: Undecided
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 deep chamfer and feather edge in people with Premolars Need Full Coverage Restoration, 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 3 inclusion and 4 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 22 Jul 2022. 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?
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?
patient satisfaction (time frame: one 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 22 Jul 2022.