Caries, DentalNCT06317857
Clinical Performance of an Alkasite-based Restorative Material
A study testing Centio Forte in people with Caries, Dental, run by Cairo University.
Trial summary
The evolution of restorative dental materials and technology has enabled the use of tooth-colored restorative materials in dental restorations, with all dentists hoping for the presence of materials that combine biocompatible qualities and aesthetics . Read more about this study
- Who is it for?
- Ages 16 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries, Dental
- What is being tested?
- Centio Forte
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 30 Jun 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 16 to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- • Patients with carious occlusal lesions with underlying dark shadow in posterior teeth (lower first molar) with ICDAS score 4.
- Patients with at least 20 teeth under occlusion.
- Age: 16-55 years.
- Co-operative patients approving to participate in the trial.
Who cannot join
- • Patients younger than 16 years old or older than 55 years old.
- Extensive occlusal lesions.
- Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis.
- Teeth supporting removable prostheses, or orthodontic appliances.
- Candidates with parafunction or bruxism.
- Candidates with systemic diseases or disabilities that may affect participation.
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- Drug-induced xerostomia.
- Heavy smoking.
- Pregnancy.
- Lack of compliance.
About this study
Official title: Clinical Performance of an Alkasite-based Restorative Material Versus Highly Viscous Glass Ionomer in Occlusal Cavities After 18 Months: A Randomized Clinical Trial
The evolution of restorative dental materials and technology has enabled the use of tooth-colored restorative materials in dental restorations, with all dentists hoping for the presence of materials that combine biocompatible qualities and aesthetics . Although resin composite materials' mechanical and aesthetic properties have greatly improved over the past 20 years, research is currently on to find ways to prevent secondary caries from forming beneath and at the margins of restorations. In order to circumvent these problems, there is a growing tendency towards the use of resin-based bioactive and remineralizing restorative materials to strengthen and lengthen the lifespan of bonded dental restorations.
Read the detailed description
The evolution of restorative dental materials and technology has enabled the use of tooth-colored restorative materials in dental restorations, with all dentists hoping for the presence of materials that combine biocompatible qualities and aesthetics . Although resin composite materials' mechanical and aesthetic properties have greatly improved over the past 20 years, research is currently on to find ways to prevent secondary caries from forming beneath and at the margins of restorations. In order to circumvent these problems, there is a growing tendency towards the use of resin-based bioactive and remineralizing restorative materials to strengthen and lengthen the lifespan of bonded dental restorations.Glass ionomer is one of the most commonly used materials in dental restorations. One of the most important properties of GICs is their ability to release fluoride and recharge. Other reasons for GIC's widespread use in the dental field are its beneficial properties such as adhesion to tooth structure, equivalent coefficient of thermal expansion of teeth, and excellent biocompatibility. However, they have disadvantages such as severe wear, high solubility, poor mechanical properties, and limited occlusal force resistance. Today's generation GICs have tried to address these disadvantages by incorporating a fast setting reinforced glass ionomer that should offer protection during the early maturation process and enhance strength and surface hardness. It has been improved by changes in the ratio of powder to liquid, particle size and dispersion. As a result, highly viscous glass ionomer (HVGIC) is available on the market. In the last few years, we have seen the introduction of a glass ionomer encapsulated with high mechanical properties as claimed by the manufacturer. The GIC, which is characterized by its rapid setting and high viscosity, could serve as an alternative to amalgam and composite restorations in cavities of class I and II for permanent teeth.
For decades, dentists have been looking for a material that is affordable, fluoride releasing, easy to apply, strong, and aesthetically pleasing. A novel bioactive, alkasite material has been introduced enabling quick and efficient minimally invasive treatment. . It is a self-curing radiopaque material for direct treatment of anterior and posterior cavities. It is claimed as a tooth coloured, bioactive, durable material to be rendered as the new alternative to amalgam for permanent Class I and II restorations. It also promotes remineralization and prevents demineralization with an advanced ion-releasing system. When the pH drops because of the growth of the cariogenic bacteria, it releases hydroxide ions to help restore the pH balance. Hydroxide ions help to prevent tooth structure from being demineralized. The fluoride and calcium ions released help remineralize the tooth structure and prevent secondary caries.
- Conditions
- Caries, Dental
- Being tested
- Centio Forte
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Centio ForteOther
A new Alkasite material has been introduced with superior strength and bioactive ion release where it is considered the new alternative to amalgam.
| Study group | Role | What they receive |
|---|---|---|
| Centio Forte (Ivoclar). | Experimental | A new class of bioactive "alkasite" restorative materials has been released in the market. They're composed of three main filler types: salinized inert barium aluminium silicate glass, calcium barium aluminium fluorosilicate glass similar to glass-ionomers, and calcium fluorosilicate glass or "alkasite" glass. Cention N (Ivoclar Vivadent) was the first available material in the material in the form of powder/liquid, later on, Cention forte was released which is the modified capsulated form with a special adhesive system Marovic et al. (2022).
Cention has the ability to remineralize hard dental tissues through calcium and fluoride release and can also neutralize bacterial acids through hydroxide ions release Par et al. (2020). Receives: Other: Centio Forte |
| Highly viscous glass ionomer | Active comparator | Glass-ionomer restorations (GI) are widely used in restorative dentistry. One of their advantages is their chemical adhesion to tooth structure. They also possess a fluoride-releasing property and biocompatibility. Although GIs are commonly used, they have some disadvantages. The most intractable problem with the conventional GIs is probably their lack of strength and toughness. In order to improve the mechanical properties of conventional GICs, reinforced GIs were developed. These reinforced GIs or now commonly known as highly viscous GIs provide improved mechanical properties and wear resistance, easier application allowing their use in posterior stress bearing cavity preparations Bakhadher et al.
(2019). Receives: Other: Centio Forte |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention success rate % with modified USPH criteria
retention of the restoration, with USPH criteria
Measured: 18 months with; T0=Baseline, T1= 6 months follow up, T2=12 months follow up and T3= 18 months follow up.
Secondary outcomes (2)
Marginal adaptation with modified USPH criteria marginal discolouration, recurrent caries, anatomic form and postoperative sensitivity.
marginal integrity of the restoration with USPH criteria
Measured: 18 months with; T0=Baseline, T1= 6 months follow up, T2=12 months follow up and T3= 18 months follow up.
Postoperative sensitivity
Degree of post operative sensitivity with USPH criteria
Measured: 18 months with; T0=Baseline, T1= 6 months follow up, T2=12 months follow up and T3= 18 months follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caries, DentalStudies 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
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarek Mohamed Tawfik Alagamawy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06317857
- Sponsor's protocol ID
- 14422021443228
- Status last verified
- Mar 2024
- First submitted
- 1 Mar 2024
- Last updated
- 19 Mar 2024
- 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 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of an Alkasite-based Restorative Material Versus Highly Viscous Glass Ionomer in Occlusal Cavities After 18 Months: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06317857
- Acronym / sponsor ID
- 14422021443228
- Conditions
- Caries, Dental
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 19 Mar 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.
The evolution of restorative dental materials and technology has enabled the use of tooth-colored restorative materials in dental restorations, with all dentists hoping for the presence of materials that combine biocompatible qualities and aesthetics . Although resin composite materials' mechanical and aesthetic properties have greatly improved over the past 20 years, research is currently on to find ways to prevent secondary caries from forming beneath and at the margins of restorations. In order to circumvent these problems, there is a growing tendency towards the use of resin-based bioactive and remineralizing restorative materials to strengthen and lengthen the lifespan of bonded dental restorations.
Detailed description
The evolution of restorative dental materials and technology has enabled the use of tooth-colored restorative materials in dental restorations, with all dentists hoping for the presence of materials that combine biocompatible qualities and aesthetics . Although resin composite materials' mechanical and aesthetic properties have greatly improved over the past 20 years, research is currently on to find ways to prevent secondary caries from forming beneath and at the margins of restorations. In order to circumvent these problems, there is a growing tendency towards the use of resin-based bioactive and remineralizing restorative materials to strengthen and lengthen the lifespan of bonded dental restorations.Glass ionomer is one of the most commonly used materials in dental restorations. One of the most important properties of GICs is their ability to release fluoride and recharge. Other reasons for GIC's widespread use in the dental field are its beneficial properties such as adhesion to tooth structure, equivalent coefficient of thermal expansion of teeth, and excellent biocompatibility. However, they have disadvantages such as severe wear, high solubility, poor mechanical properties, and limited occlusal force resistance. Today's generation GICs have tried to address these disadvantages by incorporating a fast setting reinforced glass ionomer that should offer protection during the early maturation process and enhance strength and surface hardness. It has been improved by changes in the ratio of powder to liquid, particle size and dispersion. As a result, highly viscous glass ionomer (HVGIC) is available on the market. In the last few years, we have seen the introduction of a glass ionomer encapsulated with high mechanical properties as claimed by the manufacturer. The GIC, which is characterized by its rapid setting and high viscosity, could serve as an alternative to amalgam and composite restorations in cavities of class I and II for permanent teeth.
For decades, dentists have been looking for a material that is affordable, fluoride releasing, easy to apply, strong, and aesthetically pleasing. A novel bioactive, alkasite material has been introduced enabling quick and efficient minimally invasive treatment. . It is a self-curing radiopaque material for direct treatment of anterior and posterior cavities. It is claimed as a tooth coloured, bioactive, durable material to be rendered as the new alternative to amalgam for permanent Class I and II restorations. It also promotes remineralization and prevents demineralization with an advanced ion-releasing system. When the pH drops because of the growth of the cariogenic bacteria, it releases hydroxide ions to help restore the pH balance. Hydroxide ions help to prevent tooth structure from being demineralized. The fluoride and calcium ions released help remineralize the tooth structure and prevent secondary caries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Centio Forte (Ivoclar). | Experimental | Other: Centio ForteA new class of bioactive "alkasite" restorative materials has been released in the market. They're composed of three main filler types: salinized inert barium aluminium silicate glass, calcium barium aluminium fluorosilicate glass similar to glass-ionomers, and calcium fluorosilicate glass or "alkasite" glass. Cention N (Ivoclar Vivadent) was the first available material in the material in the form of powder/liquid, later on, Cention forte was released which is the modified capsulated form with a special adhesive system Marovic et al. (2022). Cention has the ability to remineralize hard dental tissues through calcium and fluoride release and can also neutralize bacterial acids through hydroxide ions release Par et al. (2020). |
| Highly viscous glass ionomer | Active comparator | Other: Centio ForteGlass-ionomer restorations (GI) are widely used in restorative dentistry. One of their advantages is their chemical adhesion to tooth structure. They also possess a fluoride-releasing property and biocompatibility. Although GIs are commonly used, they have some disadvantages. The most intractable problem with the conventional GIs is probably their lack of strength and toughness. In order to improve the mechanical properties of conventional GICs, reinforced GIs were developed. These reinforced GIs or now commonly known as highly viscous GIs provide improved mechanical properties and wear resistance, easier application allowing their use in posterior stress bearing cavity preparations Bakhadher et al. (2019). |
Who may qualify
- Ages
- 16 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- • Patients with carious occlusal lesions with underlying dark shadow in posterior teeth (lower first molar) with ICDAS score 4.
Key exclusion criteria (10 listed)
- • Patients younger than 16 years old or older than 55 years old.
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 |
|---|---|---|
| Centio ForteA new Alkasite material has been introduced with superior strength and bioactive ion release where it is considered the new alternative to amalgam. | Other | Centio Forte (Ivoclar)., Highly viscous glass ionomer |
Primary outcome
Retention success rate % with modified USPH criteria
Time frame: 18 months with; T0=Baseline, T1= 6 months follow up, T2=12 months follow up and T3= 18 months follow up.
retention of the restoration, with USPH criteria
2 secondary outcomes
Marginal adaptation with modified USPH criteria marginal discolouration, recurrent caries, anatomic form and postoperative sensitivity.
Time frame: 18 months with; T0=Baseline, T1= 6 months follow up, T2=12 months follow up and T3= 18 months follow up.
Postoperative sensitivity
Time frame: 18 months with; T0=Baseline, T1= 6 months follow up, T2=12 months follow up and T3= 18 months follow up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Centio Forte in people with Caries, Dental, 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 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: status not confirmed, as of the sponsor's last update on 19 Mar 2024. 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?
Results are not available in the source record.
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?
Retention success rate % with modified USPH criteria (time frame: 18 months with; T0=Baseline, T1= 6 months follow up, T2=12 months follow up and T3= 18 months follow up.). 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 2024.