ClinicalTrials.gg
Not yet recruitingNCT07788274Updated Aug 28, 2026

Zirconomer-P Versus RMGI for Proximal Restorations in Primary Molars

An interventional study of Zirconia-fortified glass ionomer and Resin-modified glass ionomer in Dental Caries, sponsored by Cairo University. Not yet recruiting at 1 site in Egypt. Open to participants aged 4 Years to 7 Years. Per ClinicalTrials.gov, last updated 2026-08-28.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
4 Years to 7 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 151 studies in Dental Caries by Cairo University — 41 open to participants now, 43 under way, none of them phase 3. Dental Caries · Cairo University.

Planned enrollment
43rd of 120
50 · median 46
Started
2026
with 10 others
No phase
101 of 151
29 open now
Primary completion
2028-03
later than 41 of 42 live
Registered
148th of 151
by date

Among the 151 studies in Dental Caries by Cairo University, this one is the 43rd largest by planned enrollment of the 120 interventional ones that give a count, is one of 11 that started in 2026, is one of 101 with no phase, reaches primary completion later than 41 of the 42 other live ones, and was the 148th registered.

Dental Caries

1,171 studies on the registry are indexed under Dental Caries; 209 are open to participants now.

Browse Dental Caries studies →

Open to participants now

41 of the 151 studies in Dental Caries by Cairo University are open now, in 1 country. Recruiting first, the newest first:

35 more — sign in →

By country, each count listing its studies:

All 41 open studies →

Where they have run

Who these studies take

Of the 86 Dental Caries studies recruiting now, 18 (21%) set no upper age limit and 66 (77%) stop at 75 or younger; 60 take children under 18; 53 take healthy volunteers.

This study: 4 Years to 7 Years · all sexes · no healthy volunteers.

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02

Study 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 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.

03

Conditions studied

  • Dental Caries

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Keywords

  • Primary molars
  • Proximal caries
  • Zirconomer-P
  • Zirconia-fortified glass ionomer
  • Resin-modified glass ionomer
  • RMGI
  • Dental restorations
  • Primary teeth
  • Pediatric dentistry
  • FDI criteria
04

Who can participate

Ages eligible
4 Years to 7 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Generally cooperative children who can be managed by the operators.
  • Parent/legal guardian willing to sign the .
  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • Sensitivity to axial or lateral percussion.
  • Mobile teeth.
  • External or internal resorption.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Zirconomer-P

    Participants assigned to this arm will receive zirconia-fortified glass ionomer (Zirconomer-P capsules) for restoration of proximal cavities in primary molars.

    Combination Product: Zirconia-fortified glass ionomer

  • Active comparator
    RMGI

    Participants assigned to this arm will receive resin-modified glass ionomer (FX-Ultra) for restoration of proximal cavities in primary molars.

    Combination Product: Resin-modified glass ionomer

Interventions

  • Combination productZirconia-fortified glass ionomer

    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.

    Also known as: Zirconomer-P

  • Combination productResin-modified glass ionomer

    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.

    Also known as: FX-Ultra

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: Baseline, 3, 6, 12, and 18 months after restoration

07

Study locations

1 site
  • Faculty of Dentistry, Cairo University -Pediatric Dentistry Department Clinic
    Cairo, Egypt
08

References and documents

Individual participant data

Plan to share: 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

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Mar 2028, 18 months later.

Of 469 non-industry interventional studies with no phase under Dental Caries, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 30. This study's planned 18 months is above that.

Counting every sponsor, half of 502 studies reached it within 15 months; a quarter within 7 and three quarters within 29.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 22, 2026
First posted
Aug 26, 2026
StartEst.
Sep 30, 2026
Primary completionEst.
Mar 30, 2028
CompletionEst.
Mar 30, 2028
Last update
Aug 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07788274
Lead sponsor
Cairo University
Responsible party
Radwa Mohamed Galal (Main Researcher, Cairo University) — Principal investigator
First posted
Aug 26, 2026
Start date
Sep 30, 2026 (estimated)
Primary completion
Mar 30, 2028 (estimated)
Completion
Mar 30, 2028 (estimated)
Last update
Aug 28, 2026

Study contacts

Radwa Mohamed Galal, BDS, MSc
Contact
radwa.radwan@dentistry.cu.edu.eg
+201111831265

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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