Dental CariesNCT05403008
Clinical Performance and Wear Resistance of Highly Translucent Nano Zirconia Reinforced Glass Ionomer Filling Versus Conventional Resin Composite Restorations in Patients With Proximal Carious Teeth. (A One-year Randomized Clinical Trial).
A study testing Zirconomer improved in people with Dental Caries, run by Cairo University.
Trial summary
This randomized clinical study aims to evaluate the clinical performance and occlusal wear resistance of nano-zirconia reinforced glass ionomer restorations in comparison to Nano-hybrid resin composite in proximal cavities. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Zirconomer improved
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Jun 2022to Feb 2023
- 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
- Age group 18-55
- Presence of occluding tooth.
- Good oral hygiene
Who cannot join
- Poor periodontal status
- Adverse medical history.
- Potential behavioral problems
Trial locations and contacts
No sites are listed yet.
About this study
This randomized clinical study aims to evaluate the clinical performance and occlusal wear resistance of nano-zirconia reinforced glass ionomer restorations in comparison to Nano-hybrid resin composite in proximal cavities.
Read the detailed description
Statement of the problem:
The glass ionomer restorations have a wide use in dental community. Proximal restoration is a challenge, due to the high forces present in this area that require more high fracture resistance restoration material which is not obtained in the most of the versions of glass ionomer restorations that are available in dental market.(Safy, 2019)
Rationale for choice of intervention:
Zirconomer improved, is a nano zirconia reinforced glass ionomer, which has improved the mechanical, esthetic and handling properties than its previous successor, zirconomer. Zirconomer is commercialized as a white amalgam as it features mechanical properties similar to amalgam restorations. In this generation also, translucency is improved to be similar to the tooth structure.(Shetty et al, 2017) As Zirconomer improved is reinforced material, it is expected that has high wear resistance than the conventional glass ionomer restorations. (Hesse et al., 2018)
- Conditions
- Dental Caries
- Being tested
- Zirconomer improved
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zirconomer improvedOther
Zirconomer improved, is a nano zirconia reinforced glass ionomer, which has improved the mechanical, esthetic and handling properties than its previous successor.
| Study group | Role | What they receive |
|---|---|---|
| Zirconomer improved | Other | a nano zirconia reinforced glass ionomer, which has improved the mechanical, esthetic and handling properties than its previous successor. Receives: Other: Zirconomer improved |
| Nano hybird resin composite | Active comparator | Resin composite (RC) is the gold standard esthetic restoration in proximal cavities due to their high aesthetic properties, increased mechanical durability and enhanced adhesion to tooth structure. Receives: Other: Zirconomer improved |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical performance
Postoperative Hypersensitivity Secondary caries
Measured: Change from the baseline at 6 months and at 12 months.
Clinical performance
Secondary caries and measured by Modified United States Public Health Service Criteria (USPHS)
Measured: Change from the baseline at 6 months and at 12 months.
Clinical performance
Gross fracture and measured by Modified United States Public Health Service Criteria (USPHS)
Measured: Change from the baseline at 6 months and at 12 months.
Clinical performance
Color match and measured by Modified United States Public Health Service Criteria (USPHS)
Measured: Change from the baseline at 6 months and at 12 months.
Clinical performance
Cavo-surface marginal discoloration and measured by Modified United States Public Health Service Criteria (USPHS)
Measured: Change from the baseline at 6 months and at 12 months.
Clinical performance
Marginal integrity and measured by Modified United States Public Health Service Criteria (USPHS)
Measured: Change from the baseline at 6 months and at 12 months.
Clinical performance
Proximal contact and measured by Modified United States Public Health Service Criteria (USPHS)
Measured: Change from the baseline at 6 months and at 12 months.
Secondary outcomes (1)
Wear resistance evaluation
"Wear measurements Measured by using WSxM software.
Measured: Change from the baseline at 6 months and at 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study startJun 2022 (estimated)
- Primary completionJun 2022 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies 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
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weaam Mohamed Abdelfatah Abdelfatah Ammar, Cairo University
- Investigators
- Ahmed El-Hoshy, Professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05403008
- Sponsor's protocol ID
- Zirconomer Improved
- Status last verified
- May 2022
- First submitted
- 2 Feb 2022
- Last updated
- 2 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance and Wear Resistance of Highly Translucent Nano Zirconia Reinforced Glass Ionomer Filling Versus Conventional Resin Composite Restorations in Patients With Proximal Carious Teeth. (A One-year Randomized Clinical Trial).
- ClinicalTrials.gov ID
- NCT05403008
- Acronym / sponsor ID
- Zirconomer Improved
- Conditions
- Dental Caries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jun 2022 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 2 Jun 2022 (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.
This randomized clinical study aims to evaluate the clinical performance and occlusal wear resistance of nano-zirconia reinforced glass ionomer restorations in comparison to Nano-hybrid resin composite in proximal cavities.
Detailed description
Statement of the problem:
The glass ionomer restorations have a wide use in dental community. Proximal restoration is a challenge, due to the high forces present in this area that require more high fracture resistance restoration material which is not obtained in the most of the versions of glass ionomer restorations that are available in dental market.(Safy, 2019)
Rationale for choice of intervention:
Zirconomer improved, is a nano zirconia reinforced glass ionomer, which has improved the mechanical, esthetic and handling properties than its previous successor, zirconomer. Zirconomer is commercialized as a white amalgam as it features mechanical properties similar to amalgam restorations. In this generation also, translucency is improved to be similar to the tooth structure.(Shetty et al, 2017) As Zirconomer improved is reinforced material, it is expected that has high wear resistance than the conventional glass ionomer restorations. (Hesse et al., 2018)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zirconomer improved | Other | Other: Zirconomer improveda nano zirconia reinforced glass ionomer, which has improved the mechanical, esthetic and handling properties than its previous successor. |
| Nano hybird resin composite | Active comparator | Other: Zirconomer improvedResin composite (RC) is the gold standard esthetic restoration in proximal cavities due to their high aesthetic properties, increased mechanical durability and enhanced adhesion to tooth structure. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age group 18-55
- Presence of occluding tooth.
- Good oral hygiene
Key exclusion criteria (3 listed)
- Poor periodontal status
- Adverse medical history.
- Potential behavioral problems
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 |
|---|---|---|
| Zirconomer improvedZirconomer improved, is a nano zirconia reinforced glass ionomer, which has improved the mechanical, esthetic and handling properties than its previous successor. | Other | Nano hybird resin composite, Zirconomer improved |
Primary outcome
Clinical performance
Time frame: Change from the baseline at 6 months and at 12 months.
Postoperative Hypersensitivity Secondary caries
Clinical performance
Time frame: Change from the baseline at 6 months and at 12 months.
Secondary caries and measured by Modified United States Public Health Service Criteria (USPHS)
Clinical performance
Time frame: Change from the baseline at 6 months and at 12 months.
Gross fracture and measured by Modified United States Public Health Service Criteria (USPHS)
Clinical performance
Time frame: Change from the baseline at 6 months and at 12 months.
Color match and measured by Modified United States Public Health Service Criteria (USPHS)
Clinical performance
Time frame: Change from the baseline at 6 months and at 12 months.
Cavo-surface marginal discoloration and measured by Modified United States Public Health Service Criteria (USPHS)
Clinical performance
Time frame: Change from the baseline at 6 months and at 12 months.
Marginal integrity and measured by Modified United States Public Health Service Criteria (USPHS)
Clinical performance
Time frame: Change from the baseline at 6 months and at 12 months.
Proximal contact and measured by Modified United States Public Health Service Criteria (USPHS)
1 secondary outcome
Wear resistance evaluation
Time frame: Change from the baseline at 6 months and at 12 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
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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.
Ahmed El-Hoshy, Professor study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Zirconomer improved in people with Dental Caries, 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 3 inclusion and 3 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 2 Jun 2022. 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 weaam mohamed ammar, master (00201009432333, weaam.abdelfatah@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical performance (time frame: Change from the baseline at 6 months and at 12 months.). The study lists 7 primary outcomes in all. 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 2 Jun 2022.