Dental CariesNCT06901453
The Effectiveness RMGI and Giomer, Individually and Combined Anterior Cervical Caries
A study testing Low shrinkage Giomer restorative material (Beautifil II LS) in people with Dental Caries and Cervical Caries, run by Cairo University.
Trial summary
This study compares the effectiveness of three dental materials for restoring anterior cervical caries in high-risk patients: resin-modified glass ionomer (RMGI), Giomer, and a combination technique where RMGI is veneered with Giomer. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Dental Caries, Cervical Caries
- What is being tested?
- Low shrinkage Giomer restorative material (Beautifil II LS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to 1 May 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient age range from 18-55 years
- Presence of anterior cervical caries on the labial surface (ICDAS 4 \& 5)
- High caries risk
- Good general health
Who cannot join
- Severe or chronic periodontal disease
- Bruxism
- Non-vital teeth
- Fractured or cracked teeth
- Defective restorations
- Pregnancy and/or lactation
- Allergy to the main components of the products to be used in the study
About this study
Official title: Effectiveness of RMGI and Giomer, Both Individually and in Combination, for Restoring Anterior Cervical Caries in High-Risk Patients: A Randomized Clinical Trial
This study compares the effectiveness of three dental materials for restoring anterior cervical caries in high-risk patients: resin-modified glass ionomer (RMGI), Giomer, and a combination technique where RMGI is veneered with Giomer. The 18-month randomized clinical trial will assess 75 patients (25 per group), primarily evaluating secondary caries formation, with additional measurements of restoration integrity, appearance, and sensitivity at baseline, 6, 12, and 18 months.
Read the detailed description
This study aims to evaluate the clinical performance of three different restorative materials for treating anterior cervical caries in high-risk patients over 18 months. The research will compare resin-modified glass ionomer (RMGI), Giomer, and a combination technique where RMGI is veneered with Giomer (lamination technique). The randomized controlled clinical trial will involve 75 patients, with 25 patients in each treatment group. The primary outcome is secondary caries assessment, while secondary outcomes include fracture, retention, marginal integrity, marginal discoloration, anatomic form, surface texture, and postoperative sensitivity. Assessments will occur at baseline, 6, 12, and 18 months using modified USPHS criteria.
The rationale behind this study is that high-risk caries patients need restorative materials that provide both protection against recurrent decay and aesthetic outcomes. The bioactive properties of these materials, including fluoride release and remineralization capabilities, make them potentially suitable for these patients. The research protocol includes detailed methods for patient selection, randomization, blinding, treatment procedures, follow-up assessments, and statistical analysis. The study is self-funded and will be conducted at the Conservative Dentistry Department, Faculty of Dentistry, Cairo University, with appropriate ethical approvals and informed consent.
- Conditions
- Dental Caries, Cervical Caries
- Being tested
- Low shrinkage Giomer restorative material (Beautifil II LS), RMGI alone - Control
- Keywords
- Risk Factor, Patient Outcome Assessment
- Medical subject headings
- Dental Caries, Root Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low shrinkage Giomer restorative material (Beautifil II LS)Procedure or surgery
Enamel margins are etched with 37% phosphoric acid for 15 seconds, then the cavity is bonded using FL bond two-step self-etch adhesive. Giomer is applied in increments (maximum 2mm thickness) and light-cured for 20 seconds with a properly calibrated LED curing light.
RMGI alone - ControlProcedure or surgery
Cavities will be restored with light-cured resin modified glass ionomer (GC Fuji II LC) only. After applying conditioner for 20 seconds, rinsing, and gentle drying, the RMGI will fill the entire cavity and be light-cured
| Study group | Role | What they receive |
|---|---|---|
| Group 2 (RMGI + Giomer Lamination) | Experimental | Cavities will be restored using a combination technique where light-cured resin modified glass ionomer (GC Fuji II LC) is applied first, leaving 1.5mm space for Giomer. After selective enamel etching, adhesive will be applied to both enamel and dentin margins as well as the RMGI floor, followed by application of Beautifil II LS Giomer as the final layer. Receives: Procedure: RMGI alone - Control |
| Group 3 (RMGI alone - Control) | Active comparator | Cavities will be restored with light-cured resin modified glass ionomer (GC Fuji II LC) only. After applying conditioner for 20 seconds, rinsing, and gentle drying, the RMGI will fill the entire cavity and be light-cured. GC Fuji Varnish will be applied before and after finishing to prevent moisture penetration. Receives: Procedure: Low shrinkage Giomer restorative material (Beautifil II LS) |
| Group 1 (Giomer) | Active comparator | Cavities will be restored with low shrinkage Giomer restorative material (Beautifil II LS, Shofu, Japan). After etching enamel margins with 37% phosphoric acid for 15 seconds, FL bond two-step self-etch adhesive will be applied, followed by incremental application of Giomer (maximum 2mm thickness) with light-curing for 20 seconds. Receives: Procedure: RMGI alone - Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Secondary Caries
The methodology includes visual examination, short air drying, and the use of a 250-μm probe to assess for the presence of secondary caries around the restorations.
Measured: 6 months
Secondary Caries
The methodology includes visual examination, short air drying, and the use of a 250-μm probe to assess for the presence of secondary caries around the restorations.
Measured: 12 months
Secondary Caries
The methodology includes visual examination, short air drying, and the use of a 250-μm probe to assess for the presence of secondary caries around the restorations.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start1 May 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion1 May 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
- Model description
- This randomized controlled trial compares three bioactive restorative materials (Giomer, RMGI veneered with Giomer, and RMGI alone) for treating anterior cervical caries in high-risk patients. 75 participants (25 per group) will be evaluated over 18 months for secondary caries (primary outcome), restoration integrity, appearance, and sensitivity using modified USPHS criteria at baseline, 6, 12, and 18 months. The parallel-group superiority design with 1:1:1 allocation will include blinded outcome assessment at the Conservative Dentistry Department, Cairo University.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Magdy Eldamanhoury, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06901453
- Sponsor's protocol ID
- CairoU-Bioactive Veneering
- Status last verified
- Mar 2025
- First submitted
- 23 Mar 2025
- Last updated
- 30 Mar 2025
- 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 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of RMGI and Giomer, Both Individually and in Combination, for Restoring Anterior Cervical Caries in High-Risk Patients: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06901453
- Acronym / sponsor ID
- CairoU-Bioactive Veneering
- Conditions
- Dental Caries, Cervical Caries
- Keywords
- Risk Factor, Patient Outcome Assessment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 30 Mar 2025 (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 compares the effectiveness of three dental materials for restoring anterior cervical caries in high-risk patients: resin-modified glass ionomer (RMGI), Giomer, and a combination technique where RMGI is veneered with Giomer. The 18-month randomized clinical trial will assess 75 patients (25 per group), primarily evaluating secondary caries formation, with additional measurements of restoration integrity, appearance, and sensitivity at baseline, 6, 12, and 18 months.
Detailed description
This study aims to evaluate the clinical performance of three different restorative materials for treating anterior cervical caries in high-risk patients over 18 months. The research will compare resin-modified glass ionomer (RMGI), Giomer, and a combination technique where RMGI is veneered with Giomer (lamination technique). The randomized controlled clinical trial will involve 75 patients, with 25 patients in each treatment group. The primary outcome is secondary caries assessment, while secondary outcomes include fracture, retention, marginal integrity, marginal discoloration, anatomic form, surface texture, and postoperative sensitivity. Assessments will occur at baseline, 6, 12, and 18 months using modified USPHS criteria.
The rationale behind this study is that high-risk caries patients need restorative materials that provide both protection against recurrent decay and aesthetic outcomes. The bioactive properties of these materials, including fluoride release and remineralization capabilities, make them potentially suitable for these patients. The research protocol includes detailed methods for patient selection, randomization, blinding, treatment procedures, follow-up assessments, and statistical analysis. The study is self-funded and will be conducted at the Conservative Dentistry Department, Faculty of Dentistry, Cairo University, with appropriate ethical approvals and informed consent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- This randomized controlled trial compares three bioactive restorative materials (Giomer, RMGI veneered with Giomer, and RMGI alone) for treating anterior cervical caries in high-risk patients. 75 participants (25 per group) will be evaluated over 18 months for secondary caries (primary outcome), restoration integrity, appearance, and sensitivity using modified USPHS criteria at baseline, 6, 12, and 18 months. The parallel-group superiority design with 1:1:1 allocation will include blinded outcome assessment at the Conservative Dentistry Department, Cairo University.
| Arm | Type | Receives |
|---|---|---|
| Group 2 (RMGI + Giomer Lamination) | Experimental | Procedure: RMGI alone - ControlCavities will be restored using a combination technique where light-cured resin modified glass ionomer (GC Fuji II LC) is applied first, leaving 1.5mm space for Giomer. After selective enamel etching, adhesive will be applied to both enamel and dentin margins as well as the RMGI floor, followed by application of Beautifil II LS Giomer as the final layer. |
| Group 3 (RMGI alone - Control) | Active comparator | Procedure: Low shrinkage Giomer restorative material (Beautifil II LS)Cavities will be restored with light-cured resin modified glass ionomer (GC Fuji II LC) only. After applying conditioner for 20 seconds, rinsing, and gentle drying, the RMGI will fill the entire cavity and be light-cured. GC Fuji Varnish will be applied before and after finishing to prevent moisture penetration. |
| Group 1 (Giomer) | Active comparator | Procedure: RMGI alone - ControlCavities will be restored with low shrinkage Giomer restorative material (Beautifil II LS, Shofu, Japan). After etching enamel margins with 37% phosphoric acid for 15 seconds, FL bond two-step self-etch adhesive will be applied, followed by incremental application of Giomer (maximum 2mm thickness) with light-curing for 20 seconds. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patient age range from 18-55 years
- Presence of anterior cervical caries on the labial surface (ICDAS 4 \& 5)
- High caries risk
- Good general health
Key exclusion criteria (7 listed)
- Severe or chronic periodontal disease
- Bruxism
- Non-vital teeth
- Fractured or cracked teeth
- Defective 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 |
|---|---|---|
| Low shrinkage Giomer restorative material (Beautifil II LS)Enamel margins are etched with 37% phosphoric acid for 15 seconds, then the cavity is bonded using FL bond two-step self-etch adhesive. Giomer is applied in increments (maximum 2mm thickness) and light-cured for 20 seconds with a properly calibrated LED curing light. | Procedure or surgery | Group 3 (RMGI alone - Control) |
| RMGI alone - ControlCavities will be restored with light-cured resin modified glass ionomer (GC Fuji II LC) only. After applying conditioner for 20 seconds, rinsing, and gentle drying, the RMGI will fill the entire cavity and be light-cured | Procedure or surgery | Group 1 (Giomer), Group 2 (RMGI + Giomer Lamination) |
Primary outcome
Secondary Caries
Time frame: 6 months
The methodology includes visual examination, short air drying, and the use of a 250-μm probe to assess for the presence of secondary caries around the restorations.
Secondary Caries
Time frame: 12 months
The methodology includes visual examination, short air drying, and the use of a 250-μm probe to assess for the presence of secondary caries around the restorations.
Secondary Caries
Time frame: 18 months
The methodology includes visual examination, short air drying, and the use of a 250-μm probe to assess for the presence of secondary caries around the restorations.
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 30 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Dental Caries
Active, not recruiting
Clinical Evaluation of a New Dual-cure Universal Adhesive
Class I Dental Restorations, Class II Dental Restorations
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
Not yet recruiting
Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Light-Cured Silver Diamine Fluoride in Carious Primary Molars
Dental Caries
Not yet recruiting
Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities
Dental Caries, Cavity, Dental
Not yet recruiting
Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque ATP-Bioluminescence Readings
Dental Caries, Dental Plaque
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Low shrinkage Giomer restorative material (Beautifil II LS) in people with Dental Caries and Cervical 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 4 inclusion and 7 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 30 Mar 2025. 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?
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?
Secondary Caries (time frame: 6 months). The study lists 3 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 30 Mar 2025.