Single Anterior CrownsNCT04738513
One Year Clinical Evaluation of New Gradient Technology Monolithic Zirconia (5Y-TZP/3Y-TZP) Crowns in Dental Esthetic Zone With Vertical Versus Conventional Preparation Techniques
A study testing Vertical preparation technique and Conventional Preparation technique in people with Single Anterior Crowns and Badly Decayed Teeth, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the clinical behavior of zirconia crowns in dental esthetic zone with vertical versus conventional preparation techniques using a new gradient technology monolithic zirconia (5Y-TZP/3Y-TZP). Read more about this study
- Who is it for?
- Ages 21 to 50 years
- Conditions the study is for
- Single Anterior Crowns, Badly Decayed Teeth, Endodontically Treated Teeth
- What is being tested?
- Vertical preparation technique and Conventional Preparation technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2021to 1 Jul 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 21 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- From 21-50 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 all ceramic crowns in esthetic zone;
- Badly decayed teeth
- Teeth restored with large filling restorations
Show all 11Show fewer
- Endodontically treated teeth
- Malformed teeth
- Malposed teeth (Tilted, over-erupted, rotated, etc.)
- Able to return for follow-up examinations and evaluation.
- Thick gingival biotype.
Who cannot join
- Patient less than 21or more than 50 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.
Rana Sherif, Professor contact
Egypt1 site, 1 recruiting
- Recruiting
Cairo university
Cairo, 11865
Menna ElGendy, Master, 00201093302027, mennaelgendy@dentistry.cu.edu.eg
Rana Sherif
About this study
Official title: One Year Clinical Evaluation of New Gradient Technology Monolithic Zirconia (5Y-TZP/3Y-TZP) Crowns in Dental Esthetic Zone With Vertical Versus Conventional Preparation Techniques (Randomized Clinical Trial)
The aim of this study is to evaluate the clinical behavior of zirconia crowns in dental esthetic zone with vertical versus conventional preparation techniques using a new gradient technology monolithic zirconia (5Y-TZP/3Y-TZP).
Read the detailed description
Introduction: A good relationship between dental restorations and the periodontium is one of the most important aspects to ensure clinical success both in terms of esthetics and function. Dental preparation for fixed prostheses can take various forms classified as horizontal preparation with a defined margin (chamfer), or vertical, or without a margin/finish line. According to some clinical reports, vertical preparation technique provides an increases in the gingival thickness and a greater stability of the gingival margin. Moreover, vertical preparation is characterized by being more conservative with tooth structure. Also, taking impressions is easier since it is a finish area and not a defined line.
Null hypothesis:
- There will be no difference between vertical and conventional preparations in the clinical behavior of zirconia crowns in dental esthetic zone at baseline,3,6,9,12 months evaluation.
- There will be no difference between vertical and conventional preparations in the patient satisfaction of zirconia crowns in dental esthetic zone at baseline,3,6,9,12 months evaluation.
- Conditions
- Single Anterior Crowns, Badly Decayed Teeth, Endodontically Treated Teeth, Spacing Between Anterior Teeth, Malposed Teeth(Tilted,Overerupted,Totated,Etc.)
- Being tested
- Vertical preparation technique, Conventional Preparation technique
- Medical subject headings
- Tooth, Nonvital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vertical preparation techniqueProcedure or surgery
Also called Vertiprep
Teeth in dental esthetic zone will receive Monolithic Zirconia (5Y-TZP/3Y-TZP) Crowns using vertical preparation technique.
Conventional Preparation techniqueProcedure or surgery
Teeth in dental esthetic zone will receive Monolithic Zirconia (5Y-TZP/3Y-TZP) Crowns using conventional preparation technique.
| Study group | Role | What they receive |
|---|---|---|
| Conventional preparation technique | Active comparator | Monolithic Zirconia (5Y-TZP/3Y-TZP) Crowns using conventional preparation technique. Receives: Procedure: Conventional Preparation technique |
| Vertical preprartion | Experimental | Monolithic Zirconia (5Y-TZP/3Y-TZP) Crowns using Vertical preparation technique. Receives: Procedure: Vertical preparation technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal integrity
Measured by using Modified United States Public Health Service criteria (USPHS criteria)
- Alpha (A) the explorer does not catch when drawn across the surface of the restoration toward the tooth, or, if the explorer does not catch, there is no visible crevice along the periphery of the restoration (visual inspection explorer)
- Bravo (B) the explorer catches and the is visible evidence of the crevice, which the explorer penetrates, indicating that the edge of the restoration does not adapt closely to the tooth structure. The dentin and/or the base is not exposed, and the restoration is not mobile ( visual inspection and explorer)
- Charlie (C) the explorer penetrates crevice defect extended to the dento-enamel junction (explorer)
Measured: 1 year
Secondary outcomes (5)
Gingival discoloration
Measured by using Modified United States Public Health Service criteria (USPHS criteria)
- Alpha (A) None,
- Bravo (B) Slight discoloration, removable by finishing,
- Charlie (C) Discoloration, localized not removable,
- Delta (D) Strong discoloration in major parts of the margin not removable
Measured: 1 year
Gingival inflammation
Measured by using Modified United States Public Health Service criteria (USPHS criteria) Alpha (A) Non, Bravo (B) Slight, Charlie (C) Moderate, Delta (D) Severe
Measured: 1 year
Restoration color stability
Measured by using Modified United States Public Health Service criteria (USPHS criteria) Alpha(A) No change, Bravo(B) change in comparison to baseline condition
Measured: 1 year
Secondary caries
Measured by using Modified United States Public Health Service criteria (USPHS criteria) Alpha (A) Non, Bravo (B) Caries present
Measured: 1 year
patient satisfaction
Measured by Visual Analog Scale VAS (Questionnaire) a numerical scale from ("0" unsatisfied to "10" satisfied)
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 posted4 Feb 2021
- Study start1 Mar 2021 (estimated)
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Single Anterior CrownsStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mennatalla Ahmed Emad ElGendy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04738513
- Sponsor's protocol ID
- 351020
- Status last verified
- Feb 2021
- First submitted
- 31 Jan 2021
- Last updated
- 5 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One Year Clinical Evaluation of New Gradient Technology Monolithic Zirconia (5Y-TZP/3Y-TZP) Crowns in Dental Esthetic Zone With Vertical Versus Conventional Preparation Techniques (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT04738513
- Acronym / sponsor ID
- 351020
- Conditions
- Single Anterior Crowns, Badly Decayed Teeth, Endodontically Treated Teeth, Spacing Between Anterior Teeth, Malposed Teeth(Tilted,Overerupted,Totated,Etc.)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 4 Feb 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.
The aim of this study is to evaluate the clinical behavior of zirconia crowns in dental esthetic zone with vertical versus conventional preparation techniques using a new gradient technology monolithic zirconia (5Y-TZP/3Y-TZP).
Detailed description
Introduction: A good relationship between dental restorations and the periodontium is one of the most important aspects to ensure clinical success both in terms of esthetics and function. Dental preparation for fixed prostheses can take various forms classified as horizontal preparation with a defined margin (chamfer), or vertical, or without a margin/finish line. According to some clinical reports, vertical preparation technique provides an increases in the gingival thickness and a greater stability of the gingival margin. Moreover, vertical preparation is characterized by being more conservative with tooth structure. Also, taking impressions is easier since it is a finish area and not a defined line.
Null hypothesis:
- There will be no difference between vertical and conventional preparations in the clinical behavior of zirconia crowns in dental esthetic zone at baseline,3,6,9,12 months evaluation.
- There will be no difference between vertical and conventional preparations in the patient satisfaction of zirconia crowns in dental esthetic zone at baseline,3,6,9,12 months evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional preparation technique | Active comparator | Procedure: Conventional Preparation techniqueMonolithic Zirconia (5Y-TZP/3Y-TZP) Crowns using conventional preparation technique. |
| Vertical preprartion | Experimental | Procedure: Vertical preparation techniqueMonolithic Zirconia (5Y-TZP/3Y-TZP) Crowns using Vertical preparation technique. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- From 21-50 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 all ceramic crowns in esthetic zone;
- Able to return for follow-up examinations and evaluation.
Key exclusion criteria (8 listed)
- Patient less than 21or more than 50 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 |
|---|---|---|
| Vertical preparation techniqueAlso: VertiprepTeeth in dental esthetic zone will receive Monolithic Zirconia (5Y-TZP/3Y-TZP) Crowns using vertical preparation technique. | Procedure or surgery | Vertical preprartion |
| Conventional Preparation techniqueTeeth in dental esthetic zone will receive Monolithic Zirconia (5Y-TZP/3Y-TZP) Crowns using conventional preparation technique. | Procedure or surgery | Conventional preparation technique |
Primary outcome
Marginal integrity
Time frame: 1 year
Measured by using Modified United States Public Health Service criteria (USPHS criteria) * Alpha (A) the explorer does not catch when drawn across the surface of the restoration toward the tooth, or, if the explorer does not catch, there is no visible crevice along the periphery of the restoration (visual inspection explorer) * Bravo (B) the explorer catches and the is visible evidence of the crevice, which the explorer penetrates, indicating that the edge of the restoration does not adapt closely to the tooth structure. The dentin and/or the base is not exposed, and the restoration is not mobile ( visual inspection and explorer) * Charlie (C) the explorer penetrates crevice defect extended to the dento-enamel junction (explorer)
5 secondary outcomes
Gingival discoloration
Time frame: 1 year
Gingival inflammation
Time frame: 1 year
Restoration color stability
Time frame: 1 year
Secondary caries
Time frame: 1 year
patient satisfaction
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
- 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.
Rana Sherif, Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vertical preparation technique and Conventional Preparation technique in people with Single Anterior Crowns and Badly Decayed 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 11 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 5 Feb 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Menna ElGendy, MSD (00201093302027, mennaelgendy@dentisrty.cu.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: 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 5 Feb 2021.