Class V Dental CariesNCT06673888
Assessment of Alkasite Restorative Material Versus Resin Modified Glass Ionomer in Class V Cavities: A Clinical Trial
A study testing Resin modified glass ionomer and alkasite based restorative material in people with Class V Dental Caries, run by Cairo University at 1 site in Egypt.
Trial summary
This study will be conducted to evaluate the clinical assessment of an alkasite based resin composite restorative material compared to resin modified glass ionomer based restorative material in class V cavities of anterior teeth over 12 months follow up using modified USPHS criteria. Read more about this study
- Who is it for?
- Ages 30 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Class V Dental Caries
- What is being tested?
- Resin modified glass ionomer and alkasite based restorative material
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2024to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • Adults (30-40Ys) with class V cavities (ICDAS 4 or 5) in upper anterior teeth.
- Males or females.
- Have sufficient cognitive ability to understand consent procedures.
- Co-operative patients approving to participate in the trial.
- Anterior tooth cervical carious lesion with ICDAS score 4 or 5.
- Vital upper anterior teeth with no signs or symptoms of irreversible pulpitis.
- Mobility grade: no clinical mobility.
- Teeth with healthy periodontium.
Who cannot join
- • Disabilities.
- Systemic diseases or severe medically compromised.
- Lack of compliance.
- Evidence of severe bruxism, clenching or temporomandibular joint disorders.
- Cognitive impairment
- Periapical pathosis or signs of pulpal pathology.
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- Non-vital tooth.
- Signs of pathological wear.
- Endodontically treated tooth.
- Severe periodontal affection or tooth indicated for extraction.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Assessment of an Alkasite-Based Resin Composite Restorative Material Versus Resin Modified Glass Ionomer-Based Restorative Material in Class V Cavities: One Year Randomized Clinical Trial
This study will be conducted to evaluate the clinical assessment of an alkasite based resin composite restorative material compared to resin modified glass ionomer based restorative material in class V cavities of anterior teeth over 12 months follow up using modified USPHS criteria.
In patients with anterior cervical (class V) carious lesions, will the novel alkasite-based restorative material show similar clinical assessment as resin modified glass ionomer over a one year follow up period?
Read the detailed description
Dental caries is a common chronic infectious illness caused by cariogenic bacteria that metabolize sugars to generate acid, which gradually demineralizes tooth structure. Dental caries is a major healthcare problem as it is the most prevalent disease worldwide. Low socioeconomic level groups are more likely to be affected by the disease and during the past thirty years, its prevalence has not considerably decreased despite being completely preventable.
Non-invasive methods (such as sealing, biofilm removal, and remineralization) should be used to treat existing early caries rather than removing the dental tissue. Cavitated lesions should be arrested or managed using a minimally invasive method, such as conservative cavity designs, and repairing defective restoration rather than replacing it.
Ion-releasing restorations are recognized for their biocompatibility with surrounding tissues and their fluoride-releasing capabilities, which are thought to help prevent caries by creating an oral environment that prevents the demineralization of surrounding hard tooth tissue.
Resin modified glass ionomer (RMGI) is utilized for a variety of purposes, as luting agents, liners/bases, and restorative materials. The RMGI is more aesthetically pleasing than the conventional glass ionomer while maintaining the clinical benefits of the former, such as the release of fluoride, recharging capabilities, prevention of decalcification of hard tooth tissue, inhibition of bacterial acid metabolism, and ease of clinical operation.
A novel family of bioactive "alkasite" restorative materials, essentially a subgroup of composite resin, represents a new era of restorative dentistry. This material is available in a capsulated form using a unique adhesive system. An alkaline filler that has the ability to release ions that neutralize acids is used in this novel material. It is stated that this substance can neutralize bacterial acids by releasing hydroxide ions and remineralize hard dental tissues by releasing calcium and fluoride. The material's release of ions may be crucial in neutralizing the effects of cariogenic bacteria, thus guarding against tooth caries.
The author conducted a study to evaluate the performance of two different restorative materials in patients with class V carious lesion in upper anterior teeth where the esthetic appearances is highly recommended.
- Conditions
- Class V Dental Caries
- Being tested
- Resin modified glass ionomer, alkasite based restorative material
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resin modified glass ionomerOther
Resin modified glass ionomer (RMGI) is utilized for a variety of purposes, as luting agents, liners/bases, and restorative materials. The RMGI is more aesthetically pleasing than the conventional glass ionomer while maintaining the clinical benefits of the former, such as the release of fluoride, recharging capabilities, prevention of decalcification of hard tooth tissue, inhibition of bacterial acid metabolism, and ease of clinical operation.
alkasite based restorative materialOther
Cention forte is bioactive restorative material which has the ability to remineralize hard dental tissues through calcium and fluoride release and can also neutralize bacterial acids through hydroxide ions release.
| Study group | Role | What they receive |
|---|---|---|
| Alkasite-Based Resin Composite Restorative Material (Bioactive Material) | Experimental | Alkasite material releases hydroxyl ions, calcium, fluoride, and phosphate ions which explains its caries-prevention mechanisms. Many researches indicate that this alkasite material neutralizes acids and prevents enamel and dentin demineralization when exposed to lactic acid for an extended length of time together with the added advantageous of maximum properties and esthetics of resin composite Receives: Other: alkasite based restorative material |
| Resin Modified Glass Ionomer Restorative Material | Active comparator | Resin-modified glass-ionomers have mainly the same clinical applications as conventional glass-ionomers. Their biocompatibility and ability to release fluoride are two of their advantages. In addition, it has advantages over traditional glass ionomer in terms of stronger features, better aesthetics, earlier finishing, and longer working time. They are considered the gold standard in restoring cervical carious lesions of anterior teeth over GI due to their added benefit of higher esthetics. Receives: Other: Resin modified glass ionomer |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical assessment
Patients were evaluated immediately at baseline, then they were recalled after 6 months and after one year. Assessors were blinded to the material assignment. They evaluated restorations using modified USPHS criteria . The assessors gave a score to each restoration regarding retention succus rate. Clinical performance assessment of restorations was performed using an exploratory probe and a clinical mirror with clean, dry teeth and under direct artificial lighting. Based on Ryge's criteria (modified USPHS), were the scores as follows: Alfa (A) represented the ideal clinical situation, Bravo (B) was clinically acceptable, and Charlie (C) represented a clinically unacceptable situation (Koc Vural, 2020).
Measured: 12 months change from base line to six 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 posted5 Nov 2024
- Study start1 Dec 2024
- Primary completion1 Jun 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Class V 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Mokhtar Anwar Ismail, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06673888
- Sponsor's protocol ID
- Cention Forte Protocol
- Status last verified
- Mar 2026
- First submitted
- 30 Oct 2024
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of an Alkasite-Based Resin Composite Restorative Material Versus Resin Modified Glass Ionomer-Based Restorative Material in Class V Cavities: One Year Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06673888
- Acronym / sponsor ID
- Cention Forte Protocol
- Conditions
- Class V Dental Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 5 Nov 2024 (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 will be conducted to evaluate the clinical assessment of an alkasite based resin composite restorative material compared to resin modified glass ionomer based restorative material in class V cavities of anterior teeth over 12 months follow up using modified USPHS criteria.
In patients with anterior cervical (class V) carious lesions, will the novel alkasite-based restorative material show similar clinical assessment as resin modified glass ionomer over a one year follow up period?
Detailed description
Dental caries is a common chronic infectious illness caused by cariogenic bacteria that metabolize sugars to generate acid, which gradually demineralizes tooth structure. Dental caries is a major healthcare problem as it is the most prevalent disease worldwide. Low socioeconomic level groups are more likely to be affected by the disease and during the past thirty years, its prevalence has not considerably decreased despite being completely preventable.
Non-invasive methods (such as sealing, biofilm removal, and remineralization) should be used to treat existing early caries rather than removing the dental tissue. Cavitated lesions should be arrested or managed using a minimally invasive method, such as conservative cavity designs, and repairing defective restoration rather than replacing it.
Ion-releasing restorations are recognized for their biocompatibility with surrounding tissues and their fluoride-releasing capabilities, which are thought to help prevent caries by creating an oral environment that prevents the demineralization of surrounding hard tooth tissue.
Resin modified glass ionomer (RMGI) is utilized for a variety of purposes, as luting agents, liners/bases, and restorative materials. The RMGI is more aesthetically pleasing than the conventional glass ionomer while maintaining the clinical benefits of the former, such as the release of fluoride, recharging capabilities, prevention of decalcification of hard tooth tissue, inhibition of bacterial acid metabolism, and ease of clinical operation.
A novel family of bioactive "alkasite" restorative materials, essentially a subgroup of composite resin, represents a new era of restorative dentistry. This material is available in a capsulated form using a unique adhesive system. An alkaline filler that has the ability to release ions that neutralize acids is used in this novel material. It is stated that this substance can neutralize bacterial acids by releasing hydroxide ions and remineralize hard dental tissues by releasing calcium and fluoride. The material's release of ions may be crucial in neutralizing the effects of cariogenic bacteria, thus guarding against tooth caries.
The author conducted a study to evaluate the performance of two different restorative materials in patients with class V carious lesion in upper anterior teeth where the esthetic appearances is highly recommended.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alkasite-Based Resin Composite Restorative Material (Bioactive Material) | Experimental | Other: alkasite based restorative materialAlkasite material releases hydroxyl ions, calcium, fluoride, and phosphate ions which explains its caries-prevention mechanisms. Many researches indicate that this alkasite material neutralizes acids and prevents enamel and dentin demineralization when exposed to lactic acid for an extended length of time together with the added advantageous of maximum properties and esthetics of resin composite |
| Resin Modified Glass Ionomer Restorative Material | Active comparator | Other: Resin modified glass ionomerResin-modified glass-ionomers have mainly the same clinical applications as conventional glass-ionomers. Their biocompatibility and ability to release fluoride are two of their advantages. In addition, it has advantages over traditional glass ionomer in terms of stronger features, better aesthetics, earlier finishing, and longer working time. They are considered the gold standard in restoring cervical carious lesions of anterior teeth over GI due to their added benefit of higher esthetics. |
Who may qualify
- Ages
- 30 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- • Adults (30-40Ys) with class V cavities (ICDAS 4 or 5) in upper anterior teeth.
Key exclusion criteria (10 listed)
- • Disabilities.
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 |
|---|---|---|
| Resin modified glass ionomerResin modified glass ionomer (RMGI) is utilized for a variety of purposes, as luting agents, liners/bases, and restorative materials. The RMGI is more aesthetically pleasing than the conventional glass ionomer while maintaining the clinical benefits of the former, such as the release of fluoride, recharging capabilities, prevention of decalcification of hard tooth tissue, inhibition of bacterial acid metabolism, and ease of clinical operation. | Other | Resin Modified Glass Ionomer Restorative Material |
| alkasite based restorative materialCention forte is bioactive restorative material which has the ability to remineralize hard dental tissues through calcium and fluoride release and can also neutralize bacterial acids through hydroxide ions release. | Other | Alkasite-Based Resin Composite Restorative Material (Bioactive Material) |
Primary outcome
clinical assessment
Time frame: 12 months change from base line to six and 12 months.
Patients were evaluated immediately at baseline, then they were recalled after 6 months and after one year. Assessors were blinded to the material assignment. They evaluated restorations using modified USPHS criteria . The assessors gave a score to each restoration regarding retention succus rate. Clinical performance assessment of restorations was performed using an exploratory probe and a clinical mirror with clean, dry teeth and under direct artificial lighting. Based on Ryge's criteria (modified USPHS), were the scores as follows: Alfa (A) represented the ideal clinical situation, Bravo (B) was clinically acceptable, and Charlie (C) represented a clinically unacceptable situation (Koc Vural, 2020).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resin modified glass ionomer and alkasite based restorative material in people with Class V 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 8 inclusion and 10 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: finished, as of the sponsor's last update on 19 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
clinical assessment (time frame: 12 months change from base line to six 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 19 Mar 2026.