Wear, OcclusalNCT04798300
Wear of Enamel Antagonist to Two Different Types of Monolithic Zirconia Monolithic Zirconia
A study testing Newly Introduced Gradient Monolithic Zirconia and Full Strength Monolithic Zirconia in people with Wear, Occlusal, run by Cairo University.
Trial summary
The aim of the present study is to evaluate the wear of enamel opposed by Newly Introduced Gradient Monolithic Zirconia compared to that of enamel opposed by Full Strength Monolithic Zirconia Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Wear, Occlusal
- What is being tested?
- Newly Introduced Gradient Monolithic Zirconia and Full Strength Monolithic Zirconia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2021to 1 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- -
- All subjects are required to be:
- From 18-50 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 planned for a single coverage restoration in the posterior area.
- Patients with a natural (not crowned) opposing antagonist.
- Able to return for follow-up examinations and evaluation.
Who cannot join
- Patient less than 18 or more than 50 years 2. Patients with severe clenching or bruxing habits. 3. Patient with active resistant periodontal diseases 4. Patients with poor oral hygiene and uncooperative patients 5. Pregnant women 6. Patients in the growth stage with partially erupted teeth 7. Psychiatric problems or unrealistic expectations 8. Lack of opposing dentition at the area of interest. 9. Presence of dental prosthesis in the opposing arch at the area of interest.
About this study
Official title: Wear of Enamel Antagonist to Two Different Types of Monolithic Zirconia: A Randomized Clinical Trial
The aim of the present study is to evaluate the wear of enamel opposed by Newly Introduced Gradient Monolithic Zirconia compared to that of enamel opposed by Full Strength Monolithic Zirconia
Read the detailed description
The aim of the present study is to evaluate the wear of enamel opposed by Newly Introduced Gradient Monolithic Zirconia compared to that of enamel opposed by Full Strength Monolithic Zirconia Teeth preparation and impressions, placement and permanent cementation of the final restoration using resin cement, and optical scanning of both the restoration and the opposing tooth. Follow up postoperatively after six and twelve months, and optical scanning of both the restoration and the opposing tooth.
- Conditions
- Wear, Occlusal
- Being tested
- Newly Introduced Gradient Monolithic Zirconia, Full Strength Monolithic Zirconia
- Medical subject headings
- Tooth Attrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Newly Introduced Gradient Monolithic ZirconiaProcedure or surgery
Fabrication of full-coverage crowns over posterior teeth using Newly Introduced Gradient Monolithic Zirconia to measure wear
Full Strength Monolithic ZirconiaProcedure or surgery
Fabrication of full-coverage crowns over posterior teeth using Full Strength Monolithic Zirconia to measure wear
| Study group | Role | What they receive |
|---|---|---|
| tested material | Other | Newly Introduced Gradient Monolithic Zirconia (Intervention) Receives: Procedure: Newly Introduced Gradient Monolithic Zirconia |
| comparator material | Active comparator | Full Strength Monolithic Zirconia (Comparator) Receives: Procedure: Full Strength Monolithic Zirconia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enamel wear of teeth opposing the restorations to be tested opposing to tested restorations
measured by Geomagic professional software
Measured: one year
Secondary outcomes (1)
Wear of restorations to tested opposed to natural teeth
measured by Geomagic professional software
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 posted15 Mar 2021
- Study start1 Sep 2021 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Wear, OcclusalStudies 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, Sara Ismail Mohamed Hussein, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04798300
- Sponsor's protocol ID
- 171020
- Status last verified
- Jun 2021
- First submitted
- 28 Jan 2021
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Hussein SIM, Anwar EM, Nabil O. Wear of enamel antagonist to gradient zirconia vs full strength monolithic zirconia: a randomized clinical trial. BMC Oral Health. 2026 Jan 17;26(1):233. doi: 10.1186/s12903-025-07566-y.
PubMed 41547826
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wear of Enamel Antagonist to Two Different Types of Monolithic Zirconia: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04798300
- Acronym / sponsor ID
- 171020
- Conditions
- Wear, Occlusal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 15 Mar 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 the present study is to evaluate the wear of enamel opposed by Newly Introduced Gradient Monolithic Zirconia compared to that of enamel opposed by Full Strength Monolithic Zirconia
Detailed description
The aim of the present study is to evaluate the wear of enamel opposed by Newly Introduced Gradient Monolithic Zirconia compared to that of enamel opposed by Full Strength Monolithic Zirconia Teeth preparation and impressions, placement and permanent cementation of the final restoration using resin cement, and optical scanning of both the restoration and the opposing tooth. Follow up postoperatively after six and twelve months, and optical scanning of both the restoration and the opposing tooth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tested material | Other | Procedure: Newly Introduced Gradient Monolithic ZirconiaNewly Introduced Gradient Monolithic Zirconia (Intervention) |
| comparator material | Active comparator | Procedure: Full Strength Monolithic ZirconiaFull Strength Monolithic Zirconia (Comparator) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- -
- From 18-50 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 planned for a single coverage restoration in the posterior area.
Key exclusion criteria (1 listed)
- Patient less than 18 or more than 50 years 2. Patients with severe clenching or bruxing habits. 3. Patient with active resistant periodontal diseases 4. Patients with poor oral hygiene and uncooperative patients 5. Pregnant women 6. Patients in the growth stage with partially erupted teeth 7. Psychiatric problems or unrealistic expectations 8. Lack of opposing dentition at the area of interest. 9. Presence of dental prosthesis in the opposing arch at the area of interest.
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 |
|---|---|---|
| Newly Introduced Gradient Monolithic ZirconiaFabrication of full-coverage crowns over posterior teeth using Newly Introduced Gradient Monolithic Zirconia to measure wear | Procedure or surgery | tested material |
| Full Strength Monolithic ZirconiaFabrication of full-coverage crowns over posterior teeth using Full Strength Monolithic Zirconia to measure wear | Procedure or surgery | comparator material |
Primary outcome
Enamel wear of teeth opposing the restorations to be tested opposing to tested restorations
Time frame: one year
measured by Geomagic professional software
1 secondary outcome
Wear of restorations to tested opposed to natural teeth
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
- Derived from this study: PubMed 41547826Hussein SIM, Anwar EM, Nabil O. Wear of enamel antagonist to gradient zirconia vs full strength monolithic zirconia: a randomized clinical trial. BMC Oral Health. 2026 Jan 17;26(1):233. doi: 10.1186/s12903-025-07566-y.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Newly Introduced Gradient Monolithic Zirconia and Full Strength Monolithic Zirconia in people with Wear, Occlusal, 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 8 inclusion and 1 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 18 Jun 2021. 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?
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?
Enamel wear of teeth opposing the restorations to be tested opposing to tested restorations (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04798300, which also lists 1 linked publication.
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 18 Jun 2021.