Single Crowns in Aesthetic Dental ZoneNCT04320758
One Year Clinical Evaluation of Translucent Zirconia Crowns in Dental Esthetic Zone With Biologically Oriented Preparation Technique (BOPT) Versus Conventional Preparation (Randomized Clinical Trial)
A study testing conventional preparation design and biologically oriented preparation technique in people with Single Crowns in Aesthetic Dental Zone, run by Cairo University at 1 site in Egypt.
Trial summary
Aim of the studyto evaluate the clinical behavior of translucent zirconia crown in dental esthetic zone with biologically oriented preparation technique versus conventional preparation. Read more about this study
- Who is it for?
- Ages 21 to 35 years
- Conditions the study is for
- Single Crowns in Aesthetic Dental Zone
- What is being tested?
- conventional preparation design and biologically oriented preparation technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Oct 2020to 30 Dec 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 21 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All subjects are required to be:
- From 21-35 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 with teeth problems indicated for single all ceramic restoration in maxillary esthetic zone cr
- Badly decayed teeth
Show all 12Show fewer
- Teeth restored with large filling restorations
- Endodontically treated teeth
- Malformed teeth
- Malposed teeth (Tilted, over-erupted, rotated, etc.)
- Spacing between maxillary teeth in esthetic zone
- Able to return for follow-up examinations and evaluation
Who cannot join
- Patient less than 21or more than 35 years
- 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
- Patient with periodontal problems
- patients with malocclusion or parafunctional habits
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of dentistry Cairo university
Cairo, New Cairo, 02
kareem talaat Ali, M,D,s, 01002225212 ext. 02, kareemtalaat@dentistry.edu.eg
About this study
Aim of the studyto evaluate the clinical behavior of translucent zirconia crown in dental esthetic zone with biologically oriented preparation technique versus conventional preparation.
- Conditions
- Single Crowns in Aesthetic Dental Zone
- Being tested
- conventional preparation design, biologically oriented preparation technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional preparation designOther
Also called horizontal preparation technique
chamfer finish line
biologically oriented preparation techniqueOther
Also called vertical perpetration technique
shoulder less preparation design
| Study group | Role | What they receive |
|---|---|---|
| single crown in dental aesthetic zone | Experimental | teeth in dental aesthetic zone Receives: Other: conventional preparation design |
| teeth need single crown in dental aesthetic zone | Experimental | teeth in dental aesthetic zone Receives: Other: biologically oriented preparation technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal adaptation
Measured using Modified USPHS criteria1
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 posted25 Mar 2020
- Study start30 Oct 2020 (estimated)
- Primary completion30 Oct 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Single Crowns in Aesthetic Dental ZoneStudies 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
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kareem Talaat Abdelwahab Ahmed Ali, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04320758
- Sponsor's protocol ID
- 2019-09-30
- Status last verified
- Sep 2020
- First submitted
- 23 Mar 2020
- Last updated
- 17 Sep 2020
- 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 17 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One Year Clinical Evaluation of Translucent Zirconia Crowns in Dental Esthetic Zone With Biologically Oriented Preparation Technique (BOPT) Versus Conventional Preparation (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT04320758
- Acronym / sponsor ID
- 2019-09-30
- Conditions
- Single Crowns in Aesthetic Dental Zone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Oct 2020 (estimated)
- Primary completion
- 30 Oct 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 25 Mar 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.
Aim of the studyto evaluate the clinical behavior of translucent zirconia crown in dental esthetic zone with biologically oriented preparation technique versus conventional preparation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single crown in dental aesthetic zone | Experimental | Other: conventional preparation designteeth in dental aesthetic zone |
| teeth need single crown in dental aesthetic zone | Experimental | Other: biologically oriented preparation techniqueteeth in dental aesthetic zone |
Who may qualify
- Ages
- 21 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- All subjects are required to be:
Key exclusion criteria (8 listed)
- Patient less than 21or more than 35 years
- 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
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 |
|---|---|---|
| conventional preparation designAlso: horizontal preparation techniquechamfer finish line | Other | single crown in dental aesthetic zone |
| biologically oriented preparation techniqueAlso: vertical perpetration techniqueshoulder less preparation design | Other | teeth need single crown in dental aesthetic zone |
Primary outcome
Marginal adaptation
Time frame: 1 year
Measured using Modified USPHS criteria1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2020.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional preparation design and biologically oriented preparation technique in people with Single Crowns in Aesthetic Dental Zone, 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 12 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 17 Sep 2020. 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?
Contact Kareem Talaat Ali, M>D>s (01002225212 ext. 002, kareemtalaat@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Marginal adaptation (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 17 Sep 2020.