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Clinical Performance of an Alkasite-based Restorative Material

Clinical Performance of an Alkasite-based Restorative Material Versus Highly Viscous Glass Ionomer in Occlusal Cavities After 18 Months: A Randomized Clinical Trial

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06317857
Enrollment
68
Registered
2024-03-19
Start date
2024-04-01
Completion date
2025-06-30
Last updated
2024-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caries, Dental

Brief 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 . 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.

Interventions

OTHERCentio Forte

A new Alkasite material has been introduced with superior strength and bioactive ion release where it is considered the new alternative to amalgam.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
16 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

* • 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.

Exclusion criteria

* • 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. * Drug-induced xerostomia. * Heavy smoking. * Pregnancy. * Lack of compliance.

Design outcomes

Primary

MeasureTime frameDescription
Retention success rate % with modified USPH criteria18 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

Secondary

MeasureTime frameDescription
Marginal adaptation with modified USPH criteria marginal discolouration, recurrent caries, anatomic form and postoperative sensitivity.18 months with; T0=Baseline, T1= 6 months follow up, T2=12 months follow up and T3= 18 months follow up.marginal integrity of the restoration with USPH criteria
Postoperative sensitivity18 months with; T0=Baseline, T1= 6 months follow up, T2=12 months follow up and T3= 18 months follow up.Degree of post operative sensitivity with USPH criteria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026