Dental CariesGIOMER-RCTNCT07561216
Injectable Bioactive Composites vs RMGI for Proximal Cavities in Primary Molars
A study testing giomer and RMGI in people with Dental Caries, run by Cairo University.
Trial summary
This randomized clinical trial aims to evaluate and compare the clinical performance of injectable bioactive composite (Beautifil Flow Plus X, Shofu) versus Resin Modified Glass Ionomer (RMGI) in restoring proximal cavities (Class II) in primary molars of children aged 3-8 years over a 12-month follow-up period, using… Read more about this study
- Who is it for?
- Ages 3 to 8 years
- Conditions the study is for
- Dental Caries
- What is being tested?
- giomer and RMGI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- May 2026to Sep 2027
- 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 3 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 3-8 years of both genders
- Cooperative behavior manageable by operators
- Willing to sign informed consent
- Accepts the follow-up period
- Moderate to low caries risk according to Cariogram application
- Posterior primary molar with proximal carious lesion (ICDAS 3 or 4) with no signs or symptoms of pulpal involvement
- Radiographically extending to outer 1/3 of dentin
Who cannot join
- Allergy to any restorative materials
- Patients undergoing orthodontic treatment with fixed appliances
- Patients with debilitating systemic diseases
- Children with special needs
- Teeth with previous restorations
- Periapical radiolucencies or sensitivity to percussion
Show all 9Show fewer
- Mobile teeth
- External or internal resorption
- Cervical carious lesions
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Dina Mohamed contact
About this study
Official title: Clinical Evaluation of Injectable Bioactive Composites Versus Resin Modified Glass Ionomer for Restoring Proximal Cavities in Primary Molars: A Randomized Clinical Tria
This randomized clinical trial aims to evaluate and compare the clinical performance of injectable bioactive composite (Beautifil Flow Plus X, Shofu) versus Resin Modified Glass Ionomer (RMGI) in restoring proximal cavities (Class II) in primary molars of children aged 3-8 years over a 12-month follow-up period, using revised FDI criteria.
Read the detailed description
Dental caries remains the most prevalent chronic disease in children. The choice of restorative material for primary teeth significantly impacts treatment outcomes and longevity. This study compares two fluoride-releasing restorative materials in proximal cavities of primary molars.
Eligible children aged 3-8 years with ICDAS 3 or 4 proximal carious lesions in primary molars will be randomly allocated into two equal groups (24 teeth each):
Group I (Intervention): Restoration with injectable bioactive giomer (Beautifil Flow Plus X F00, Shofu) using BeautiBond Xtreme adhesive Group II (Control): Restoration with Resin Modified Glass Ionomer (RMGI)
Restorations will be clinically evaluated at baseline, 3, 6, and 12 months using revised FDI criteria assessing biological properties (secondary caries, sensitivity, tooth integrity), functional properties (marginal adaptation, proximal contact, occlusal wear, fracture/retention), and aesthetic properties.
- Conditions
- Dental Caries
- Being tested
- giomer, RMGI
- Keywords
- Randomized Clinical Trial, Primary Dentition, Giomer, RMGI, 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.
giomerOther
restoration of proximal cavities in primary molars using an injectable bioactive composite (Giomer) material. Cavities will be prepared following minimally invasive principles, isolated appropriately, and restored according to the manufacturer's instructions using adhesive bonding. Clinical performance will be evaluated in terms of retention, marginal adaptation, secondary caries, postoperative sensitivity, and overall restoration success during the follow-up period.
RMGIOther
Resin-Modified Glass Ionomer (RMGI) is a fluoride-releasing restorative material used for the restoration of carious primary teeth. It combines the properties of conventional glass ionomer cement with resin components to improve mechanical strength, adhesion, and moisture tolerance. In this study, RMGI will be used for restoring cavitated carious lesions in primary teeth following caries removal according to minimally invasive dentistry principles.
| Study group | Role | What they receive |
|---|---|---|
| RMGIC | Active comparator | cavity restorations in primary molars using a resin-modified glass ionomer cement. Following standard cavity preparation, the RMGI material will be placed according to the manufacturer's instructions. Clinical performance will be evaluated over the follow-up period in terms of restoration retention, marginal adaptation, secondary caries, postoperative sensitivity, and overall clinical success. Receives: Other: giomer |
| giomer | Experimental | restoration of proximal cavities in primary molars using an injectable bioactive composite (Giomer) material. Cavities will be prepared following minimally invasive principles, isolated appropriately, and restored according to the manufacturer's instructions using adhesive bonding. Clinical performance will be evaluated in terms of retention, marginal adaptation, secondary caries, postoperative sensitivity, and overall restoration success during the follow-up period. Receives: Other: RMGI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Secondary Caries
Assessed using revised FDI criteria (B1: caries at restoration margin). Evaluated by visual examination and short air drying. Scored on ordinal scale 1-5.
Measured: Baseline, 3, 6, and 12 months
Secondary outcomes (5)
Postoperative sensitivity / pulp status
Presence of caries at restoration margin assessed by visual examination using revised FDI criteria (B1), scored 1-5.
Measured: Baseline, 3, 6, and 12 months
Marginal Adaptation
Quality of marginal seal between restoration and tooth structure assessed using revised FDI criteria (F2), scored 1-5.
Measured: Baseline, 3, 6, and 12 months
Proximal Contact Point
Presence and quality of proximal contact between restored tooth and adjacent tooth assessed using revised FDI criteria (F3), scored 1-5
Measured: Baseline, 3, 6, and 12 months
Occlusal Wear
Degree of wear of restoration surface under occlusal loading assessed using revised FDI criteria (F5), scored 1-5
Measured: Baseline, 3, 6, and 12 months
Fracture and Retention
Presence of cracks, fractures, or loss of restoration assessed using revised FDI criteria (F1), scored 1-5
Measured: Baseline, 3, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study startMay 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionSep 2027 (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
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadine elsayed Elshayal, Cairo University
- Investigators
- Nadine Elshayal, Principal investigator, Cairo UniversityDina Ez Mohamed, Principal investigator, Cairo UniversityOsama Elshahawy, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07561216
- Sponsor's protocol ID
- CairoU-Injectable VS RMGI
- Acronym
- GIOMER-RCT
- Status last verified
- Apr 2026
- First submitted
- 18 Feb 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Injectable Bioactive Composites Versus Resin Modified Glass Ionomer for Restoring Proximal Cavities in Primary Molars: A Randomized Clinical Tria
- ClinicalTrials.gov ID
- NCT07561216
- Acronym / sponsor ID
- GIOMER-RCT / CairoU-Injectable VS RMGI
- Conditions
- Dental Caries
- Keywords
- Randomized Clinical Trial, Primary Dentition, Giomer, RMGI, FDI criteria
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 1 May 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.
This randomized clinical trial aims to evaluate and compare the clinical performance of injectable bioactive composite (Beautifil Flow Plus X, Shofu) versus Resin Modified Glass Ionomer (RMGI) in restoring proximal cavities (Class II) in primary molars of children aged 3-8 years over a 12-month follow-up period, using revised FDI criteria.
Detailed description
Dental caries remains the most prevalent chronic disease in children. The choice of restorative material for primary teeth significantly impacts treatment outcomes and longevity. This study compares two fluoride-releasing restorative materials in proximal cavities of primary molars.
Eligible children aged 3-8 years with ICDAS 3 or 4 proximal carious lesions in primary molars will be randomly allocated into two equal groups (24 teeth each):
Group I (Intervention): Restoration with injectable bioactive giomer (Beautifil Flow Plus X F00, Shofu) using BeautiBond Xtreme adhesive Group II (Control): Restoration with Resin Modified Glass Ionomer (RMGI)
Restorations will be clinically evaluated at baseline, 3, 6, and 12 months using revised FDI criteria assessing biological properties (secondary caries, sensitivity, tooth integrity), functional properties (marginal adaptation, proximal contact, occlusal wear, fracture/retention), and aesthetic properties.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RMGIC | Active comparator | Other: giomercavity restorations in primary molars using a resin-modified glass ionomer cement. Following standard cavity preparation, the RMGI material will be placed according to the manufacturer's instructions. Clinical performance will be evaluated over the follow-up period in terms of restoration retention, marginal adaptation, secondary caries, postoperative sensitivity, and overall clinical success. |
| giomer | Experimental | Other: RMGIrestoration of proximal cavities in primary molars using an injectable bioactive composite (Giomer) material. Cavities will be prepared following minimally invasive principles, isolated appropriately, and restored according to the manufacturer's instructions using adhesive bonding. Clinical performance will be evaluated in terms of retention, marginal adaptation, secondary caries, postoperative sensitivity, and overall restoration success during the follow-up period. |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Children aged 3-8 years of both genders
- Cooperative behavior manageable by operators
- Willing to sign informed consent
- Accepts the follow-up period
- Moderate to low caries risk according to Cariogram application
Key exclusion criteria (9 listed)
- Allergy to any restorative materials
- 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 |
|---|---|---|
| giomerrestoration of proximal cavities in primary molars using an injectable bioactive composite (Giomer) material. Cavities will be prepared following minimally invasive principles, isolated appropriately, and restored according to the manufacturer's instructions using adhesive bonding. Clinical performance will be evaluated in terms of retention, marginal adaptation, secondary caries, postoperative sensitivity, and overall restoration success during the follow-up period. | Other | RMGIC |
| RMGIResin-Modified Glass Ionomer (RMGI) is a fluoride-releasing restorative material used for the restoration of carious primary teeth. It combines the properties of conventional glass ionomer cement with resin components to improve mechanical strength, adhesion, and moisture tolerance. In this study, RMGI will be used for restoring cavitated carious lesions in primary teeth following caries removal according to minimally invasive dentistry principles. | Other | giomer |
Primary outcome
Secondary Caries
Time frame: Baseline, 3, 6, and 12 months
Assessed using revised FDI criteria (B1: caries at restoration margin). Evaluated by visual examination and short air drying. Scored on ordinal scale 1-5.
5 secondary outcomes
Postoperative sensitivity / pulp status
Time frame: Baseline, 3, 6, and 12 months
Marginal Adaptation
Time frame: Baseline, 3, 6, and 12 months
Proximal Contact Point
Time frame: Baseline, 3, 6, and 12 months
Occlusal Wear
Time frame: Baseline, 3, 6, and 12 months
Fracture and Retention
Time frame: Baseline, 3, 6, and 12 months
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 1 May 2026.
- Individual participant dataSharing planned: No
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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.
Dina Mohamed contact
Nadine Elshayal principal investigator
Cairo University
Dina Ez Mohamed principal investigator
Cairo University
Osama Elshahawy study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing giomer and RMGI 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 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 1 May 2026. 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?
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 Nadine Elsayed Ahmed Elshayal (01069995861, nadine.elshayal@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Secondary Caries (time frame: Baseline, 3, 6, and 12 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 1 May 2026; AzTrials last refreshed its copy on 1 Nov 2026.