Dental CariesNCT04288791
Evaluation of the Clinical Performance of Reinforced Glass Ionomer Restorations
A study testing Equia Forte Fil and Zirconomer Improved in people with Dental Caries, run by Al-Azhar University at 1 site in Egypt.
Trial summary
This study is conducted to evaluate the clinical performance of class I reinforced glass ionomer restorations (Zirconomer Improved and Equia Forte Fil) Read more about this study
- Who is it for?
- Ages 20 to 47 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Equia Forte Fil and Zirconomer Improved
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2018to 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 47 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal occlusal relation with normal dentition.
- Absence of pain from the tooth to be restored.
- Absence of any active periodontal and pulpal diseases from the tooth to be restored.
- Medium-sized (buccolingually and mesio-distally) occlusal carious lesions extending into dentin.
Who cannot join
- Patients with a history of tooth sensitivity.
- Patients with bruxism.
- Defective restorations adjacent or opposing to the tooth.
- Abutment teeth used for fixed or removable prosthesis.
- Patients who refused to sign the consent form.
- Inability to return to recall appointments
Trial locations and contacts
1 site in 1 country.
About this study
This study is conducted to evaluate the clinical performance of class I reinforced glass ionomer restorations (Zirconomer Improved and Equia Forte Fil)
- Conditions
- Dental Caries
- Being tested
- Equia Forte Fil, 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.
Equia Forte FilOther
Glass hybrid innovation achieved through the introduction of ultrafine, highly reactive glass particles dispersed with conventional GI. The restoration is coated with Equia Forte coat which incorporates multi-functional monomer producing a tougher resin matrix. This system is designed as alternative of amalgam in posterior teeth.
Zirconomer ImprovedOther
Zirconia reinforced GI, Glass Polyalkenoate restoration; it is designed to exhibit high strength where the glass component of this GI undergoes finely controlled micronization to achieve optimum particle size and characteristics .
| Study group | Role | What they receive |
|---|---|---|
| Equia Forte Fil | Experimental | Not described Receives: Other: Equia Forte Fil; Other: Zirconomer Improved |
| Zirconomer Improved | Experimental | Not described Receives: Other: Equia Forte Fil; Other: Zirconomer Improved |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Performance of the restoration
Success Rate
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start1 Jun 2018
- Primary completion1 Aug 2018
- Study completion1 Feb 2019
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 Al-Azhar 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nessma Mohamed Mahmoud Sedky, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04288791
- Sponsor's protocol ID
- REC16-033
- Status last verified
- Mar 2020
- First submitted
- 26 Feb 2020
- Last updated
- 17 Mar 2020
- 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 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinical Performance of Reinforced Glass Ionomer Restorations
- ClinicalTrials.gov ID
- NCT04288791
- Acronym / sponsor ID
- REC16-033
- Conditions
- Dental Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 28 Feb 2020 (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 study is conducted to evaluate the clinical performance of class I reinforced glass ionomer restorations (Zirconomer Improved and Equia Forte Fil)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Equia Forte Fil | Experimental | Other: Equia Forte Fil, Other: Zirconomer Improved |
| Zirconomer Improved | Experimental | Other: Equia Forte Fil, Other: Zirconomer Improved |
Who may qualify
- Ages
- 20 to 47 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Normal occlusal relation with normal dentition.
- Absence of pain from the tooth to be restored.
- Absence of any active periodontal and pulpal diseases from the tooth to be restored.
- Medium-sized (buccolingually and mesio-distally) occlusal carious lesions extending into dentin.
Key exclusion criteria (6 listed)
- Patients with a history of tooth sensitivity.
- Patients with bruxism.
- Defective restorations adjacent or opposing to the tooth.
- Abutment teeth used for fixed or removable prosthesis.
- Patients who refused to sign the consent form.
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 |
|---|---|---|
| Equia Forte FilGlass hybrid innovation achieved through the introduction of ultrafine, highly reactive glass particles dispersed with conventional GI. The restoration is coated with Equia Forte coat which incorporates multi-functional monomer producing a tougher resin matrix. This system is designed as alternative of amalgam in posterior teeth. | Other | Equia Forte Fil, Zirconomer Improved |
| Zirconomer ImprovedZirconia reinforced GI, Glass Polyalkenoate restoration; it is designed to exhibit high strength where the glass component of this GI undergoes finely controlled micronization to achieve optimum particle size and characteristics . | Other | Equia Forte Fil, Zirconomer Improved |
Primary outcome
Clinical Performance of the restoration
Time frame: 6 months
Success Rate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Equia Forte Fil and Zirconomer Improved in people with Dental Caries, run by Al-Azhar 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 4 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: finished, as of the sponsor's last update on 17 Mar 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical Performance of the restoration (time frame: 6 months). 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 17 Mar 2020.