Clinical Performance of an Alkasite-based Restorative Material

NCT06317857 | Not Yet Recruiting

• 1 other identifier: 14422021443228
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Caries, Dental

Outcome Measures

Primary Outcomes (1)

• Retention success rate % with modified USPH criteria

  retention of the restoration, with USPH criteria

  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.

  18 months with; T0=Baseline, T1= 6 months follow up, T2=12 months follow up and T3= 18 months follow up.

• Postoperative sensitivity

  18 months with; T0=Baseline, T1= 6 months follow up, T2=12 months follow up and T3= 18 months follow up.

Study Arms (2)

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).

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).

Other: Centio Forte

Interventions

Centio Forte OTHER

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

Centio Forte (Ivoclar).; Highly viscous glass ionomer

Eligibility Criteria

• Age: 16 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 19, 2024
• Study Start: April 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share