Dental CariesNCT07788274
Zirconomer-P Versus RMGI for Proximal Restorations in Primary Molars
A study testing Zirconia-fortified glass ionomer and Resin-modified glass ionomer in people with Dental Caries, run by Cairo University at 1 site in Egypt.
Trial summary
Clinical trial comparing two tooth-colored restorative materials for treating cavities between the teeth of primary molars in children aged 4 to 7 years. The study will compare zirconia-fortified glass ionomer (Zirconomer-P) with resin-modified glass ionomer (RMGI) to evaluate their clinical performance, including the… Read more about this study
- Who is it for?
- Ages 4 to 7 years
- Conditions the study is for
- Dental Caries
- What is being tested?
- Zirconia-fortified glass ionomer and Resin-modified glass ionomer
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Sep 2026to 30 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 4 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Generally cooperative children who can be managed by the operators.
- Parent/legal guardian willing to sign the informed consent.
- Acceptance of the required follow-up period.
- Moderate to low caries risk according to the Cariogram application.
- Posterior primary molar with a proximal carious lesion and no signs or symptoms of pulpal involvement.
- Bitewing radiograph showing the lesion extending to the outer one-third of dentin.
- Carious lesion classified as International Caries Detection and Assessment System (ICDAS) 3 or ICDAS 4.
Who cannot join
- Allergy to any restorative material.
- Patients undergoing orthodontic treatment with fixed appliances.
- Patients with debilitating systemic diseases.
- Children with special needs.
- Teeth with previous restorations.
- Periapical radiolucencies.
Show all 9Show fewer
- Sensitivity to axial or lateral percussion.
- Mobile teeth.
- External or internal resorption.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of Dentistry, Cairo University -Pediatric Dentistry Department Clinic
Cairo
About this study
Official title: Clinical Evaluation of Zirconia Fortified Glass Ionomer Versus Resin Modified Glass Ionomer for Restoring Proximal Cavities in Primary Molars: A Randomized Clinical Trial
Clinical trial comparing two tooth-colored restorative materials for treating cavities between the teeth of primary molars in children aged 4 to 7 years. The study will compare zirconia-fortified glass ionomer (Zirconomer-P) with resin-modified glass ionomer (RMGI) to evaluate their clinical performance, including the condition of the restoration, marginal adaptation, proximal contact, occlusion, wear, fracture, retention, and development of caries at the restoration margin. Children will be followed for up to 18 months after treatment.
Read the detailed description
This randomized clinical trial will evaluate the clinical performance of zirconia-fortified glass ionomer (Zirconomer-P capsules) compared with resin-modified glass ionomer (FX-Ultra) for restoring proximal cavities in primary molars.
The study will include children aged 4 to 7 years with posterior primary molars having proximal carious lesions classified as International Caries Detection and Assessment System (ICDAS) 3 or 4, with no clinical or radiographic signs of pulpal involvement. Eligible participants will be randomly allocated to receive either zirconia-fortified glass ionomer or resin-modified glass ionomer as the restorative material.
The restorative procedure will include dental prophylaxis, isolation of the operative field, selective removal of carious tissue, cavity preparation, placement of a matrix and wedge, and restoration using the assigned material. Local anesthesia will not be routinely administered according to the study protocol.
The primary outcome will assess the biological properties of the restorations, including caries at the restoration margin, dental hard tissue defects at the restoration margin, and postoperative hypersensitivity or pulp status. Secondary outcomes will assess functional properties, including marginal adaptation, proximal contact point, form and contour, occlusion and occlusal wear, fracture of the restorative material, and retention.
Clinical outcomes will be assessed using the revised Fédération Dentaire Internationale (FDI) criteria. Participants will be evaluated at baseline and during follow-up visits at 3, 6, 12, and 18 months after restoration. Outcome assessment will be performed by the study assessors, with calibration and assessment of inter- and intra-observer agreement before the study begins.
The study is designed to determine whether zirconia-fortified glass ionomer provides comparable or superior clinical performance to resin-modified glass ionomer for proximal restorations in primary molars over an 18-month follow-up period.
- Conditions
- Dental Caries
- Being tested
- Zirconia-fortified glass ionomer, Resin-modified glass ionomer
- Keywords
- Primary molars, Proximal caries, Zirconomer-P, Zirconia-fortified glass ionomer, Resin-modified glass ionomer, RMGI, Dental restorations, Primary teeth, Pediatric dentistry, FDI criteria
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zirconia-fortified glass ionomerCombination product
Also called Zirconomer-P
Zirconia-fortified glass ionomer (Zirconomer-P capsules) will be used to restore proximal carious cavities in primary molars. The material will be placed after selective removal of carious tissue and cavity preparation. Restorations will be clinically evaluated at baseline and at 3, 6, 12, and 18 months using the revised FDI criteria.
Resin-modified glass ionomerCombination product
Also called FX-Ultra
Resin-modified glass ionomer (FX-Ultra) will be used as the restorative material for proximal carious cavities in primary molars. The material will be applied to the gingival seat and packed into the prepared cavity using a gold-plated applicator. Participants will be followed at baseline and at 3, 6, 12, and 18 months for clinical evaluation of the restoration.
| Study group | Role | What they receive |
|---|---|---|
| Zirconomer-P | Experimental | Participants assigned to this arm will receive zirconia-fortified glass ionomer (Zirconomer-P capsules) for restoration of proximal cavities in primary molars. Receives: Combination Product: Zirconia-fortified glass ionomer |
| RMGI | Active comparator | Participants assigned to this arm will receive resin-modified glass ionomer (FX-Ultra) for restoration of proximal cavities in primary molars. Receives: Combination Product: Resin-modified glass ionomer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biological Properties of Restorations According to the Revised FDI Criteria
Assessment of biological properties of the restorations, including caries at the restoration margin, dental hard tissue defects at the restoration margin, and postoperative hypersensitivity/pulp status using the revised Fédération Dentaire Internationale (FDI) criteria.
Measured: Baseline, 3, 6, 12, and 18 months after restoration
Secondary outcomes (1)
Functional Properties of Restorations According to the Revised FDI Criteria
Assessment of the functional properties of the restorations, including marginal adaptation, proximal contact point, form and contour, occlusion and occlusal wear, fracture of the restorative material, and retention, using the revised Fédération Dentaire Internationale (FDI) criteria.
Measured: Baseline, 3, 6, 12, and 18 months after restoration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Mar 2028 (estimated)
- Study completion30 Mar 2028 (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
- Model description
- Two parallel groups will be compared in a randomized clinical trial. Eligible participants will be randomly assigned to receive either zirconia-fortified glass ionomer (Zirconomer-P capsules) or resin-modified glass ionomer (FX-Ultra) for the restoration of proximal cavities in primary molars. Clinical outcomes will be assessed at baseline and during follow-up visits over 18 months.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radwa Mohamed Galal, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07788274
- Sponsor's protocol ID
- CU-PED-ZIR-RMGI-2026
- Status last verified
- Aug 2026
- First submitted
- 22 Aug 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The plan for sharing individual participant data (IPD) with other researchers has not yet been determined. Any future data sharing will be considered in accordance with applicable ethical, privacy, and institutional requirements
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Zirconia Fortified Glass Ionomer Versus Resin Modified Glass Ionomer for Restoring Proximal Cavities in Primary Molars: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07788274
- Acronym / sponsor ID
- CU-PED-ZIR-RMGI-2026
- Conditions
- Dental Caries
- Keywords
- Primary molars, Proximal caries, Zirconomer-P, Zirconia-fortified glass ionomer, Resin-modified glass ionomer, RMGI, Dental restorations, Primary teeth
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 Mar 2028 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 26 Aug 2026 (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.
Clinical trial comparing two tooth-colored restorative materials for treating cavities between the teeth of primary molars in children aged 4 to 7 years. The study will compare zirconia-fortified glass ionomer (Zirconomer-P) with resin-modified glass ionomer (RMGI) to evaluate their clinical performance, including the condition of the restoration, marginal adaptation, proximal contact, occlusion, wear, fracture, retention, and development of caries at the restoration margin. Children will be followed for up to 18 months after treatment.
Detailed description
This randomized clinical trial will evaluate the clinical performance of zirconia-fortified glass ionomer (Zirconomer-P capsules) compared with resin-modified glass ionomer (FX-Ultra) for restoring proximal cavities in primary molars.
The study will include children aged 4 to 7 years with posterior primary molars having proximal carious lesions classified as International Caries Detection and Assessment System (ICDAS) 3 or 4, with no clinical or radiographic signs of pulpal involvement. Eligible participants will be randomly allocated to receive either zirconia-fortified glass ionomer or resin-modified glass ionomer as the restorative material.
The restorative procedure will include dental prophylaxis, isolation of the operative field, selective removal of carious tissue, cavity preparation, placement of a matrix and wedge, and restoration using the assigned material. Local anesthesia will not be routinely administered according to the study protocol.
The primary outcome will assess the biological properties of the restorations, including caries at the restoration margin, dental hard tissue defects at the restoration margin, and postoperative hypersensitivity or pulp status. Secondary outcomes will assess functional properties, including marginal adaptation, proximal contact point, form and contour, occlusion and occlusal wear, fracture of the restorative material, and retention.
Clinical outcomes will be assessed using the revised Fédération Dentaire Internationale (FDI) criteria. Participants will be evaluated at baseline and during follow-up visits at 3, 6, 12, and 18 months after restoration. Outcome assessment will be performed by the study assessors, with calibration and assessment of inter- and intra-observer agreement before the study begins.
The study is designed to determine whether zirconia-fortified glass ionomer provides comparable or superior clinical performance to resin-modified glass ionomer for proximal restorations in primary molars over an 18-month follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two parallel groups will be compared in a randomized clinical trial. Eligible participants will be randomly assigned to receive either zirconia-fortified glass ionomer (Zirconomer-P capsules) or resin-modified glass ionomer (FX-Ultra) for the restoration of proximal cavities in primary molars. Clinical outcomes will be assessed at baseline and during follow-up visits over 18 months.
| Arm | Type | Receives |
|---|---|---|
| Zirconomer-P | Experimental | Combination Product: Zirconia-fortified glass ionomerParticipants assigned to this arm will receive zirconia-fortified glass ionomer (Zirconomer-P capsules) for restoration of proximal cavities in primary molars. |
| RMGI | Active comparator | Combination Product: Resin-modified glass ionomerParticipants assigned to this arm will receive resin-modified glass ionomer (FX-Ultra) for restoration of proximal cavities in primary molars. |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Generally cooperative children who can be managed by the operators.
- Parent/legal guardian willing to sign the informed consent.
- Acceptance of the required follow-up period.
- Moderate to low caries risk according to the Cariogram application.
- Posterior primary molar with a proximal carious lesion and no signs or symptoms of pulpal involvement.
Key exclusion criteria (9 listed)
- Allergy to any restorative material.
- Patients undergoing orthodontic treatment with fixed appliances.
- Patients with debilitating systemic diseases.
- Children with special needs.
- Teeth with previous restorations.
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-fortified glass ionomerAlso: Zirconomer-PZirconia-fortified glass ionomer (Zirconomer-P capsules) will be used to restore proximal carious cavities in primary molars. The material will be placed after selective removal of carious tissue and cavity preparation. Restorations will be clinically evaluated at baseline and at 3, 6, 12, and 18 months using the revised FDI criteria. | Combination product | Zirconomer-P |
| Resin-modified glass ionomerAlso: FX-UltraResin-modified glass ionomer (FX-Ultra) will be used as the restorative material for proximal carious cavities in primary molars. The material will be applied to the gingival seat and packed into the prepared cavity using a gold-plated applicator. Participants will be followed at baseline and at 3, 6, 12, and 18 months for clinical evaluation of the restoration. | Combination product | RMGI |
Primary outcome
Biological Properties of Restorations According to the Revised FDI Criteria
Time frame: Baseline, 3, 6, 12, and 18 months after restoration
Assessment of biological properties of the restorations, including caries at the restoration margin, dental hard tissue defects at the restoration margin, and postoperative hypersensitivity/pulp status using the revised Fédération Dentaire Internationale (FDI) criteria.
1 secondary outcome
Functional Properties of Restorations According to the Revised FDI Criteria
Time frame: Baseline, 3, 6, 12, and 18 months after restoration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: Undecided. The plan for sharing individual participant data (IPD) with other researchers has not yet been determined. Any future data sharing will be considered in accordance with applicable ethical, privacy, and institutional requirements
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zirconia-fortified glass ionomer and Resin-modified glass ionomer in people with Dental Caries, run by Cairo 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 7 inclusion and 9 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: opening soon, as of the sponsor's last update on 28 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Radwa Mohamed Galal, BDS, MSc (+201111831265, radwa.radwan@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biological Properties of Restorations According to the Revised FDI Criteria (time frame: Baseline, 3, 6, 12, and 18 months after restoration). 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 Aug 2026.