Broken Tooth With ComplicationNCT03295513
Clinical Evaluation of Wear Behavior of Human Enamel and Chipping of Veneered Zirconia Against Monolithic Zirconia
A study testing Veneered zirconia and Monolithic zirconia in people with Broken Tooth With Complication and Non Vital Teeth, run by Cairo University.
Trial summary
The aim of this study is to evaluate chipping and the degree of natural enamel loss opposing to monolithic zirconia compared to veneered zirconia restoration. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Broken Tooth With Complication, Non Vital Teeth, Mutilated Teeth
- What is being tested?
- Veneered zirconia and Monolithic zirconia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2017to 1 Feb 2019
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age range of the patients from 20-60 years old; able to read and sign the informed consent document, illiterate patient will be avoided.
- Patients able physically and psychologically to tolerate conventional restorative procedures.
- Patients with no active periodontal or pulpal diseases, having teeth with good restorations.
- Patients with teeth problems indicated for full coverage restoration (e.g. Moderate to severe discoloration, coronal fracture where partial coverage would lack retention, malposed or malformed teeth).
- Patients with root canal treated teeth requiring full coverage restorations.
- Patients willing to return for follow-up examinations and evaluation.
Who cannot join
- Patients in the growth stage with partially erupted teeth.
- Patients with poor oral hygiene and motivation.
- A pregnant woman's to avoid any complication that may occur in dental office due to pregnancy or due to injected anesthetic solution.
- Patients with psychiatric problems or unrealistic expectation (patient that has phobia from dental treatments or needle bunch).
- Patients have no opposite occluding dentition in the area intended for restoration.
- Patients suffer from Para functional habits.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Evaluation of Wear Behavior of Human Enamel and Chipping of Veneered Zirconia Against Monolithic Zirconia (Randomized Controlled Clinical Trial)
The aim of this study is to evaluate chipping and the degree of natural enamel loss opposing to monolithic zirconia compared to veneered zirconia restoration.
Read the detailed description
While increase using of zirconia in extra coronal restoration as a substitute for metal ceramic restoration still high rate of technical complications specifically chipping of veneering ceramic and wear of antagonist are usually associated with veneered zirconia restoration which led to development of new monolithic zirconia to overcome these technical complications.
Therefore this study will be conducted to evaluate chipping and wear of antagonist of veneered zirconia versus monolithic zirconia all ceramic crowns in posterior area.
Benefits of the research to the patient:
Patient will receive a restoration with superior function, esthetics, and quality.
It will save teeth such as mutilated teeth, endodontically treated and teeth with massive loss of tooth structure that cannot be restored with direct restoration.
As a result of properly functioning restoration, teeth will be restored with predictable prognosis and the patient will be psychologically improved.
Benefits of the research to the clinician:
Practitioner will have the advantage to clinically assess a new material that can be used in different situations for better function and esthetic outcomes.
It will improve patient confidence with the dentist.
Explanation for choice of comparators:
The use of veneered zirconia is well documented in the literatures as successful restoration modality. A two Clinical performance of two different CAD/CAM-fabricated ceramic crowns revealed no chipping for veneered zirconia.
A 3 years Randomized Controlled Clinical Trial of Zirconia-Ceramic and Metal-Ceramic Posterior Fixed Dental Prostheses reported Alpha Scores A=66.6%, B =25% , C=5.6% and Only D= 2.8 A 5 years prospective clinical study of posterior zirconia fixed dental prosthesis reported Alpha scores greater than 95% indicating no predictable changes during the 5 years Another 3 years Randomized controlled clinical Trial of Posterior veneered zirconia for fixed dental prostheses revealed 20% chipping and also 30% reported alpha for antagonist wear and 70% reported bravo after 3 years of clinical use.
- Being tested
- Veneered zirconia, Monolithic zirconia
- Keywords
- mutilated, root canal treated teeth, and coronal fracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Veneered zirconiaOther
he use of veneered zirconia is well documented in the literatures as successful restoration modality. A two Clinical performance of two different CAD/CAM-fabricated ceramic crowns revealed no chipping for veneered zirconia
Monolithic zirconiaOther
Monolithic zirconia product presented a new generation of polycrystalline material by which full anatomical crowns and bridges can be produced
| Study group | Role | What they receive |
|---|---|---|
| veneered zirconia full coverage restorations | Active comparator | InCoris zirconia material (TZI-Densupply sirona) Receives: Other: Veneered zirconia |
| Monolithic zirconia full coverage restorations | Experimental | InCoris (TZI-Densupply sirona) Receives: Other: Monolithic zirconia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chipping
chipping of the restoration by modified USPHs criteria as Alpha (Excellent) ideal,Bravo (Acceptable) less than ideal but no modifications required, Charlie (Acceptable but modifications needed) staining or other shade modifications required, and Delta (Unacceptable) remake.
Measured: 12 month
Secondary outcomes (1)
tooth wear
Measuring the effect on natural tooth by modified USPHs criteria as Alpha(Excellent) ideal,Bravo (Acceptable) less than ideal but no modifications requiredCharlie (Acceptable but modifications needed) staining or other shade modifications required, and Delta (Unacceptable) remake.
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2017
- Study start1 Nov 2017 (estimated)
- Primary completion1 Dec 2018 (estimated)
- Study completion1 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Broken Tooth With ComplicationStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patient will receive a restoration with superior function, esthetics, and quality.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nouran Mahmoud Ibrahim Metwally, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03295513
- Sponsor's protocol ID
- CEBD-CU-2017-09-21
- Status last verified
- Sep 2017
- First submitted
- 15 Sep 2017
- Last updated
- 28 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Wear Behavior of Human Enamel and Chipping of Veneered Zirconia Against Monolithic Zirconia (Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT03295513
- Acronym / sponsor ID
- CEBD-CU-2017-09-21
- Keywords
- mutilated, root canal treated teeth, and coronal fracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2017 (estimated)
- Primary completion
- 1 Dec 2018 (estimated)
- Study completion
- 1 Feb 2019 (estimated)
- First posted
- 28 Sep 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.
The aim of this study is to evaluate chipping and the degree of natural enamel loss opposing to monolithic zirconia compared to veneered zirconia restoration.
Detailed description
While increase using of zirconia in extra coronal restoration as a substitute for metal ceramic restoration still high rate of technical complications specifically chipping of veneering ceramic and wear of antagonist are usually associated with veneered zirconia restoration which led to development of new monolithic zirconia to overcome these technical complications.
Therefore this study will be conducted to evaluate chipping and wear of antagonist of veneered zirconia versus monolithic zirconia all ceramic crowns in posterior area.
Benefits of the research to the patient:
Patient will receive a restoration with superior function, esthetics, and quality.
It will save teeth such as mutilated teeth, endodontically treated and teeth with massive loss of tooth structure that cannot be restored with direct restoration.
As a result of properly functioning restoration, teeth will be restored with predictable prognosis and the patient will be psychologically improved.
Benefits of the research to the clinician:
Practitioner will have the advantage to clinically assess a new material that can be used in different situations for better function and esthetic outcomes.
It will improve patient confidence with the dentist.
Explanation for choice of comparators:
The use of veneered zirconia is well documented in the literatures as successful restoration modality. A two Clinical performance of two different CAD/CAM-fabricated ceramic crowns revealed no chipping for veneered zirconia.
A 3 years Randomized Controlled Clinical Trial of Zirconia-Ceramic and Metal-Ceramic Posterior Fixed Dental Prostheses reported Alpha Scores A=66.6%, B =25% , C=5.6% and Only D= 2.8 A 5 years prospective clinical study of posterior zirconia fixed dental prosthesis reported Alpha scores greater than 95% indicating no predictable changes during the 5 years Another 3 years Randomized controlled clinical Trial of Posterior veneered zirconia for fixed dental prostheses revealed 20% chipping and also 30% reported alpha for antagonist wear and 70% reported bravo after 3 years of clinical use.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Patient will receive a restoration with superior function, esthetics, and quality.
| Arm | Type | Receives |
|---|---|---|
| veneered zirconia full coverage restorations | Active comparator | Other: Veneered zirconiaInCoris zirconia material (TZI-Densupply sirona) |
| Monolithic zirconia full coverage restorations | Experimental | Other: Monolithic zirconiaInCoris (TZI-Densupply sirona) |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age range of the patients from 20-60 years old; able to read and sign the informed consent document, illiterate patient will be avoided.
- Patients able physically and psychologically to tolerate conventional restorative procedures.
- Patients with no active periodontal or pulpal diseases, having teeth with good restorations.
- Patients with teeth problems indicated for full coverage restoration (e.g. Moderate to severe discoloration, coronal fracture where partial coverage would lack retention, malposed or malformed teeth).
- Patients with root canal treated teeth requiring full coverage restorations.
Key exclusion criteria (6 listed)
- Patients in the growth stage with partially erupted teeth.
- Patients with poor oral hygiene and motivation.
- A pregnant woman's to avoid any complication that may occur in dental office due to pregnancy or due to injected anesthetic solution.
- Patients with psychiatric problems or unrealistic expectation (patient that has phobia from dental treatments or needle bunch).
- Patients have no opposite occluding dentition in the area intended for restoration.
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 |
|---|---|---|
| Veneered zirconiahe use of veneered zirconia is well documented in the literatures as successful restoration modality. A two Clinical performance of two different CAD/CAM-fabricated ceramic crowns revealed no chipping for veneered zirconia | Other | veneered zirconia full coverage restorations |
| Monolithic zirconiaMonolithic zirconia product presented a new generation of polycrystalline material by which full anatomical crowns and bridges can be produced | Other | Monolithic zirconia full coverage restorations |
Primary outcome
Chipping
Time frame: 12 month
chipping of the restoration by modified USPHs criteria as Alpha (Excellent) ideal,Bravo (Acceptable) less than ideal but no modifications required, Charlie (Acceptable but modifications needed) staining or other shade modifications required, and Delta (Unacceptable) remake.
1 secondary outcome
tooth wear
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2017.
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 study testing Veneered zirconia and Monolithic zirconia in people with Broken Tooth With Complication and Non Vital Teeth, 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 6 inclusion and 6 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 2017. 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.
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 Nouran M Ibrahim (01149928886 ext. +20, nouran.mahmoud@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chipping (time frame: 12 month). 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 28 Sep 2017.