Wear of the Natural EnamelNCT03697018
Evaluation of Antagonist Wear Behavior and Patient Satisfaction of Zirconia Reinforced Lithium Silicate Glass When Compared to Monolithic Zirconia
A study testing zirconia reinforced lithium silicate glass ceramic in people with Wear of the Natural Enamel, run by Cairo University.
Trial summary
evaluation of wear behavior and patient satisfaction of monolithic zirconia and zirconia reinforced glass crowns after follow-up periods 0,3,6,12 months. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Wear of the Natural Enamel
- What is being tested?
- zirconia reinforced lithium silicate glass ceramic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Oct 2018to Dec 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
- Patient age range from 20-60 to be able to read and write in order to sign the informed consent document.
- Patients physically and psychologically able to tolerate conventional restorative procedures.
- Patients with no active periodontal and or pulpal diseases, having teeth with good restorations.
- Patients with root canal treated teeth requiring full coverage restorations.
- Patients indicated for full coverage (e.g. moderate to severe discoloration, coronal fracture, malposed or malformed teeth).
- Patients willing to return for follow-up examinations and assessments
Who cannot join
- Patients in the growth stage with partially erupted teeth.
- Patient with poor oral hygiene.
- Patients with psychiatric problems or unrealistic expectations
- Patient with no opposite occluding dentition in the area intended for restoration.
- Patient suffering from Para functional habits.
Trial locations and contacts
No sites are listed yet.
hesham katamesh, professor contact
About this study
Official title: Evaluation of Antagonist Wear Behavior and Patient Satisfaction of Monolithic Zirconia Versus Lithium Silicate Zirconia Crowns
evaluation of wear behavior and patient satisfaction of monolithic zirconia and zirconia reinforced glass crowns after follow-up periods 0,3,6,12 months.
Read the detailed description
two groups of patients will be selected according to special inclusion criteria n=13 in each group total of 26. each group will receive one of the crowns used in this study either ( monolithic zirconia or zirconia reinforced lithium silicate glass) after crown delivery wear and patient satisfaction will be recorded at 0,3,6,12 moths follow-up periods.
- Conditions
- Wear of the Natural Enamel
- Being tested
- zirconia reinforced lithium silicate glass ceramic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zirconia reinforced lithium silicate glass ceramicOther
It represent a new generation of glass ceramic material. Using an innovative manufacturing process the glass ceramic is enriched with zirconia (10% by weight) for dental CAD/CAM applications for the fabrication of inlays, onlays, crowns and anterior and posterior single tooth restorations on implant abutments.
| Study group | Role | What they receive |
|---|---|---|
| zirconia reinforced lithium silicate glass ceramic | Experimental | It represent a new generation of glass ceramic material, enriched with zirconia (10% by weight), the material offers natural esthetics with successful outcome. Receives: Other: zirconia reinforced lithium silicate glass ceramic |
| monolithic zirconia | Active comparator | Zirconia or zirconium dioxide (ZrO2) is a highly attractive ceramic material in prosthodontics due to its excellent mechanical properties. It is widely used to build prosthetic devices. Receives: Other: zirconia reinforced lithium silicate glass ceramic |
What is being measured
The primary outcome is the main question the study is designed to answer.
wear of the antagonist natural enamel
loss of opposing tooth structure which will be measured by 3D Profilometer
Measured: from baseline till one year
Secondary outcomes (1)
patient satisfaction
visual analogue scale (VAS): scale range from 0-10 for describing the intensity of pain the patient suffering. 0: no pain, 5: moderate pain, 10: unbearable pain.
Measured: from baseline till one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2018
- Study startOct 2018 (estimated)
- Primary completionOct 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wear of the Natural EnamelStudies 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
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Mohamed Hany, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03697018
- Sponsor's protocol ID
- CEBD-CU-2018-10-01
- Status last verified
- Oct 2018
- First submitted
- 2 Oct 2018
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: conditions and factors which increase degree and progression of wear and clinical behavior of monolithic zirconia and zirconia reinforced lithium silicate restorations.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Antagonist Wear Behavior and Patient Satisfaction of Monolithic Zirconia Versus Lithium Silicate Zirconia Crowns
- ClinicalTrials.gov ID
- NCT03697018
- Acronym / sponsor ID
- CEBD-CU-2018-10-01
- Conditions
- Wear of the Natural Enamel
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Oct 2018 (estimated)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 5 Oct 2018 (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 wear behavior and patient satisfaction of monolithic zirconia and zirconia reinforced glass crowns after follow-up periods 0,3,6,12 months.
Detailed description
two groups of patients will be selected according to special inclusion criteria n=13 in each group total of 26. each group will receive one of the crowns used in this study either ( monolithic zirconia or zirconia reinforced lithium silicate glass) after crown delivery wear and patient satisfaction will be recorded at 0,3,6,12 moths follow-up periods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| zirconia reinforced lithium silicate glass ceramic | Experimental | Other: zirconia reinforced lithium silicate glass ceramicIt represent a new generation of glass ceramic material, enriched with zirconia (10% by weight), the material offers natural esthetics with successful outcome. |
| monolithic zirconia | Active comparator | Other: zirconia reinforced lithium silicate glass ceramicZirconia or zirconium dioxide (ZrO2) is a highly attractive ceramic material in prosthodontics due to its excellent mechanical properties. It is widely used to build prosthetic devices. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patient age range from 20-60 to be able to read and write in order to sign the informed consent document.
- Patients physically and psychologically able to tolerate conventional restorative procedures.
- Patients with no active periodontal and or pulpal diseases, having teeth with good restorations.
- Patients with root canal treated teeth requiring full coverage restorations.
- Patients indicated for full coverage (e.g. moderate to severe discoloration, coronal fracture, malposed or malformed teeth).
Key exclusion criteria (5 listed)
- Patients in the growth stage with partially erupted teeth.
- Patient with poor oral hygiene.
- Patients with psychiatric problems or unrealistic expectations
- Patient with no opposite occluding dentition in the area intended for restoration.
- Patient suffering from Para functional habits.
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 |
|---|---|---|
| zirconia reinforced lithium silicate glass ceramicIt represent a new generation of glass ceramic material. Using an innovative manufacturing process the glass ceramic is enriched with zirconia (10% by weight) for dental CAD/CAM applications for the fabrication of inlays, onlays, crowns and anterior and posterior single tooth restorations on implant abutments. | Other | monolithic zirconia, zirconia reinforced lithium silicate glass ceramic |
Primary outcome
wear of the antagonist natural enamel
Time frame: from baseline till one year
loss of opposing tooth structure which will be measured by 3D Profilometer
1 secondary outcome
patient satisfaction
Time frame: from baseline till one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- Individual participant dataSharing planned: Undecided. conditions and factors which increase degree and progression of wear and clinical behavior of monolithic zirconia and zirconia reinforced lithium silicate restorations.
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.
hesham katamesh, professor contact
Questions about this trial
What is this clinical trial studying?
A study testing zirconia reinforced lithium silicate glass ceramic in people with Wear of the Natural Enamel, 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 5 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 9 Oct 2018. 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 esraa mohamed hany (00201005669044, esraamhany@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
wear of the antagonist natural enamel (time frame: from baseline till 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 9 Oct 2018.