High Caries Risk PatientsNCT06797843
Clinical Evaluation of Bioactive Resin Composites Versus Caries Control Technique in Management of Class I Carious Cavities in High Caries Risk Patients: a Randomized Clinical Trial
A study testing "SPRG-based" Resin Composite : (BEAUTIFIL II, Shofu Inc. Kyoto, Japan)., Alkasite based restoration : Cention N and provisional Resin modified glass ionomer followed by Nanohybrid composite in people with High Caries Risk Patients, run by Cairo University.
Trial summary
The aim of the study is to clinically evaluate the performance of S-PRG based \& Alkasite based resin composite restorations versus conventional resin composite restorations after caries control in Class I carious cavities in posterior molar teeth over 1 year follow up. Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- High Caries Risk Patients
- What is being tested?
- "SPRG-based" Resin Composite : (BEAUTIFIL II, Shofu Inc. Kyoto, Japan)., Alkasite based restoration : Cention N and provisional Resin modified glass ionomer followed by Nanohybrid composite
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Apr 2025to May 2026
- 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 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient inclusion:
- Adult Patients (Male or Females) aging ≥21-50 years.
- Patients with high level of caries risk.
- Patients with good likelihood of recall availability.
- Tooth inclusion:
- 1- Permanent posterior molar teeth with primary simple occlusal Class I carious lesions (ICDAS 3 or 4 scores) 3- 2- Vital, periodontally sound and with positive reaction to cold stimulus. 4- 3-Well-formed and fully erupted in normal functional occlusion with natural antagonist and adjacent teeth
Who cannot join
- Participants with general/systemic illness. 2- Pregnant or lactating females. 3- Concomitant participation in another research study. 4- Inability to comply with study procedures. 5- Heavy bruxism habits. 6- Last experience with allergic reactions against any components of the used materials.
- 7- Patients receiving orthodontic treatment.
- Tooth exclusion:
- Teeth with clinical symptoms of pulpitis such as spontaneous pain or sensitivity to pressure.
- Non-vital teeth, Fractured or cracked teeth.
- Secondary carious lesions.
- Hypocalcified or hypoplastic teeth.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The aim of the study is to clinically evaluate the performance of S-PRG based \& Alkasite based resin composite restorations versus conventional resin composite restorations after caries control in Class I carious cavities in posterior molar teeth over 1 year follow up.
Read the detailed description
Traditionally, less conservative methods have been employed to treat tooth decay, which implied more loss of healthy dental tissue in order to increase the mechanical retention of the restorative material. Minimally invasive treatments have been proposed as an alternative therapy, which has evolved in with the development of new biomaterials.Bioactive restorative materials, as advocated by the FDI World Dental Federation, can promote mineralization/hard tissue creation, bacterial infection control, inflammation prevention, and tissue regeneration. In simpler terms : One efficient way to achieve bioactive functionalities in dental materials is to use particles that have the ability to release particular component.The development of "Giomer" based resin composites, which have the added benefit of prolonged fluoride and other ions release as well as rechargeability, is one of the key technological advances in resin composites to promote its usage as a bioactive material.In fact, Giomers with S-PRG fillers can release more fluoride than that of other fluoride-releasing restorations.Acid neutralization capacity by S-PRG fillers, one of many bioactive functions, is in which the pH of the surrounding environment became slightly alkaline upon contact with water or acidic solutions, exhibiting a modulation impact on acidic circumstances. Owing to the release of multiple ions, such modulation effect might be brought about by the release of Sr, B, Na, and F ions clarifying an acid buffering mechanism.A modification of GIC is Cention-N, which was introduced as a new resin-based material containing alkacid fillers, such as fluoride, calcium, and hydroxide ions, to neutralize acids. Owing to being tooth-colored, inexpensive, and having good flexural strength, It's considered as a subcategory of the composite material class.With properties similar to those of GICs and RBCs, Cention-N releases calcium, hydroxyl, and fluoride ions to prevent tooth demineralization. The presence of hydroxide ions on the material's surface may be crucial in neutralizing the acids that were produced by cariogenic bacteria Additionally, the filler's release of calcium and fluoride ions contributes in remineralization process.In Conclusion; S-PRG \& Alkasite based composite restorative materials are able to release ions that contribute to tooth mineralization as well as have a modulation effect on the acidic conditions produced by oral cariogenic microorganisms.
- Conditions
- High Caries Risk Patients
- Being tested
- "SPRG-based" Resin Composite : (BEAUTIFIL II, Shofu Inc. Kyoto, Japan)., Alkasite based restoration : Cention N, provisional Resin modified glass ionomer followed by Nanohybrid composite
- Keywords
- high caries risk patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"SPRG-based" Resin Composite : (BEAUTIFIL II, Shofu Inc. Kyoto, Japan).Other
A fluoride releasing, highly aesthetic dental material that is S-PRG (Surface Pre-reacted Glass Ionomer) based , has the ability to recharge fluoride and appropriate for patients with a high caries index.
Alkasite based restoration : Cention NOther
Cention N offers tooth-coloured esthetics together with high flexural strength. The new filling material belongs to the materials group of Alkasites. The patented alkaline filler increases the release of hydroxide ions to regulate the pH value during acid attacks. As a result, demineralization can be prevented. Moreover, the release of large numbers of fluoride and calcium ions forms a sound basis for the remineralization of dental enamel. The initiator system enables good chemical self-curing.
provisional Resin modified glass ionomer followed by Nanohybrid compositeOther
Also called Traditional Caries Control Technique
GC Fuji IX GP® EXTRA is the fastest setting glass ionomer on the market.The faster final set saves valuable chair time which provides improved stability against water, an important feature in challenging oral environments. This product contains a next generation glass filler which elicits higher translucency, fluoride release, reactivity and a faster setting time.
Then followed by Conventional Nano hybrid composite restoration(Neo Spectra® ST LV, Dentsply Sirona) which is nano-ceramic, light-cured, radiopaque, universal composite with novel SphereTEC filler technology.
| Study group | Role | What they receive |
|---|---|---|
| "SPRG-based" Resin Composite. (BEAUTIFIL II, Shofu Inc. Kyoto, Japan). | Experimental | A fluoride releasing, highly aesthetic dental material for all classes of restorations with S-PRG (Surface Pre-reacted Glass Ionomer) technology in regards to it's ability to recharge fluoride and appropriate for patients with a high caries index. Receives: Other: "SPRG-based" Resin Composite : (BEAUTIFIL II, Shofu Inc. Kyoto, Japan). |
| "Alkasite-based" restoration. (Cention N) | Experimental | Cention N offers tooth-coloured esthetics together with high flexural strength. The new filling material belongs to the materials group of Alkasites. The patented alkaline filler increases the release of hydroxide ions to regulate the pH value during acid attacks. As a result, demineralization can be prevented. Moreover, the release of large numbers of fluoride and calcium ions forms a sound basis for the remineralization of dental enamel. The initiator system enables good chemical self-curing. |
| Provisional RMGI(Fuji IX EXTRA),followed by nanohybrid resin composite(Neo Spectra® ST LV, Dentsply) | Active comparator | Traditional caries control technique by provisional Resin Modified Glass ionomer for 3 months period and then followed by removal and application of conventional nano hybrid composites. Receives: Other: provisional Resin modified glass ionomer followed by Nanohybrid composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative (hypersensitivity) and tooth vitality.
Revised FDI Criteria for Biological properties and by scoring:
- clinically very good
- clinically good
- clinically sufficient
- clinically unsatisfactory
- clinically poor
Measured: at baseline, 3 months, 6 months and 12 months.
Caries at restoration margin (CAR).
Revised FDI Criteria for Biological properties and by scoring:
- clinically very good
- clinically good
- clinically sufficient
- clinically unsatisfactory
- clinically poor
Measured: at baseline,3 months, 6 months and 12 months.
Secondary outcomes (1)
Cost effectiveness
- Cost of single restoration at baseline (for both groups) (Mean, ±SD). B. Average cost per restoration after1 year (Mean, ±SD).
- - (for intervention group in case of adverse effects) (Mean, ±SD).
- - (for control group: cost of the replacement with final restoration) in addition to the cost of adverse effects (Mean, ±SD).
Measured: at baseline, 3 months, 6 months 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 posted29 Jan 2025
- Study startApr 2025 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Caries Risk PatientsStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Mansour Khalil Mansour, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06797843
- Sponsor's protocol ID
- 14422023456853
- Status last verified
- Mar 2025
- First submitted
- 21 Jan 2025
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Bioactive Resin Composites Versus Caries Control Technique in Management of Class I Carious Cavities in High Caries Risk Patients: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06797843
- Acronym / sponsor ID
- 14422023456853
- Conditions
- High Caries Risk Patients
- Keywords
- high caries risk patients
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Apr 2025 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 29 Jan 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.
The aim of the study is to clinically evaluate the performance of S-PRG based \& Alkasite based resin composite restorations versus conventional resin composite restorations after caries control in Class I carious cavities in posterior molar teeth over 1 year follow up.
Detailed description
Traditionally, less conservative methods have been employed to treat tooth decay, which implied more loss of healthy dental tissue in order to increase the mechanical retention of the restorative material. Minimally invasive treatments have been proposed as an alternative therapy, which has evolved in with the development of new biomaterials.Bioactive restorative materials, as advocated by the FDI World Dental Federation, can promote mineralization/hard tissue creation, bacterial infection control, inflammation prevention, and tissue regeneration. In simpler terms : One efficient way to achieve bioactive functionalities in dental materials is to use particles that have the ability to release particular component.The development of "Giomer" based resin composites, which have the added benefit of prolonged fluoride and other ions release as well as rechargeability, is one of the key technological advances in resin composites to promote its usage as a bioactive material.In fact, Giomers with S-PRG fillers can release more fluoride than that of other fluoride-releasing restorations.Acid neutralization capacity by S-PRG fillers, one of many bioactive functions, is in which the pH of the surrounding environment became slightly alkaline upon contact with water or acidic solutions, exhibiting a modulation impact on acidic circumstances. Owing to the release of multiple ions, such modulation effect might be brought about by the release of Sr, B, Na, and F ions clarifying an acid buffering mechanism.A modification of GIC is Cention-N, which was introduced as a new resin-based material containing alkacid fillers, such as fluoride, calcium, and hydroxide ions, to neutralize acids. Owing to being tooth-colored, inexpensive, and having good flexural strength, It's considered as a subcategory of the composite material class.With properties similar to those of GICs and RBCs, Cention-N releases calcium, hydroxyl, and fluoride ions to prevent tooth demineralization. The presence of hydroxide ions on the material's surface may be crucial in neutralizing the acids that were produced by cariogenic bacteria Additionally, the filler's release of calcium and fluoride ions contributes in remineralization process.In Conclusion; S-PRG \& Alkasite based composite restorative materials are able to release ions that contribute to tooth mineralization as well as have a modulation effect on the acidic conditions produced by oral cariogenic microorganisms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| "SPRG-based" Resin Composite. (BEAUTIFIL II, Shofu Inc. Kyoto, Japan). | Experimental | Other: "SPRG-based" Resin Composite : (BEAUTIFIL II, Shofu Inc. Kyoto, Japan).A fluoride releasing, highly aesthetic dental material for all classes of restorations with S-PRG (Surface Pre-reacted Glass Ionomer) technology in regards to it's ability to recharge fluoride and appropriate for patients with a high caries index. |
| "Alkasite-based" restoration. (Cention N) | Experimental | –Cention N offers tooth-coloured esthetics together with high flexural strength. The new filling material belongs to the materials group of Alkasites. The patented alkaline filler increases the release of hydroxide ions to regulate the pH value during acid attacks. As a result, demineralization can be prevented. Moreover, the release of large numbers of fluoride and calcium ions forms a sound basis for the remineralization of dental enamel. The initiator system enables good chemical self-curing. |
| Provisional RMGI(Fuji IX EXTRA),followed by nanohybrid resin composite(Neo Spectra® ST LV, Dentsply) | Active comparator | Other: provisional Resin modified glass ionomer followed by Nanohybrid compositeTraditional caries control technique by provisional Resin Modified Glass ionomer for 3 months period and then followed by removal and application of conventional nano hybrid composites. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patient inclusion:
- 1- Permanent posterior molar teeth with primary simple occlusal Class I carious lesions (ICDAS 3 or 4 scores) 3- 2- Vital, periodontally sound and with positive reaction to cold stimulus. 4- 3-Well-formed and fully erupted in normal functional occlusion with natural antagonist and adjacent teeth
Key exclusion criteria (7 listed)
- Participants with general/systemic illness. 2- Pregnant or lactating females. 3- Concomitant participation in another research study. 4- Inability to comply with study procedures. 5- Heavy bruxism habits. 6- Last experience with allergic reactions against any components of the used materials.
- 7- Patients receiving orthodontic treatment.
- Teeth with clinical symptoms of pulpitis such as spontaneous pain or sensitivity to pressure.
- Non-vital teeth, Fractured or cracked teeth.
- Secondary carious lesions.
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 |
|---|---|---|
| "SPRG-based" Resin Composite : (BEAUTIFIL II, Shofu Inc. Kyoto, Japan).A fluoride releasing, highly aesthetic dental material that is S-PRG (Surface Pre-reacted Glass Ionomer) based , has the ability to recharge fluoride and appropriate for patients with a high caries index. | Other | "SPRG-based" Resin Composite. (BEAUTIFIL II, Shofu Inc. Kyoto, Japan). |
| Alkasite based restoration : Cention NCention N offers tooth-coloured esthetics together with high flexural strength. The new filling material belongs to the materials group of Alkasites. The patented alkaline filler increases the release of hydroxide ions to regulate the pH value during acid attacks. As a result, demineralization can be prevented. Moreover, the release of large numbers of fluoride and calcium ions forms a sound basis for the remineralization of dental enamel. The initiator system enables good chemical self-curing. | Other | – |
| provisional Resin modified glass ionomer followed by Nanohybrid compositeAlso: Traditional Caries Control TechniqueGC Fuji IX GP® EXTRA is the fastest setting glass ionomer on the market.The faster final set saves valuable chair time which provides improved stability against water, an important feature in challenging oral environments. This product contains a next generation glass filler which elicits higher translucency, fluoride release, reactivity and a faster setting time. Then followed by Conventional Nano hybrid composite restoration(Neo Spectra® ST LV, Dentsply Sirona) which is nano-ceramic, light-cured, radiopaque, universal composite with novel SphereTEC filler technology. | Other | Provisional RMGI(Fuji IX EXTRA),followed by nanohybrid resin composite(Neo Spectra® ST LV, Dentsply) |
Primary outcome
Postoperative (hypersensitivity) and tooth vitality.
Time frame: at baseline, 3 months, 6 months and 12 months.
Revised FDI Criteria for Biological properties and by scoring: 1. clinically very good 2. clinically good 3. clinically sufficient 4. clinically unsatisfactory 5. clinically poor
Caries at restoration margin (CAR).
Time frame: at baseline,3 months, 6 months and 12 months.
Revised FDI Criteria for Biological properties and by scoring: 1. clinically very good 2. clinically good 3. clinically sufficient 4. clinically unsatisfactory 5. clinically poor
1 secondary outcome
Cost effectiveness
Time frame: at baseline, 3 months, 6 months 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 24 Mar 2025.
Related trials for High Caries Risk Patients
Not yet recruiting
The Effectiveness RMGI and Giomer, Individually and Combined Anterior Cervical Caries
Dental Caries, Cervical Caries
Enrolling by invitation
Clinical Evaluation of Different Bioactive Restorative Materials for Cervical Carious in High Caries Risk Patients
Class V Dental Caries, High Caries Risk Patients
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.
Questions about this trial
What is this clinical trial studying?
A study testing "SPRG-based" Resin Composite : (BEAUTIFIL II, Shofu Inc. Kyoto, Japan)., Alkasite based restoration : Cention N and provisional Resin modified glass ionomer followed by Nanohybrid composite in people with High Caries Risk Patients, 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 6 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 24 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?
Contact Sara M Khalil, Bachelor Degree(BDS) (+20-2(01008927568), sara-mansour@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative (hypersensitivity) and tooth vitality. (time frame: at baseline, 3 months, 6 months and 12 months.). The study lists 2 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 24 Mar 2025.