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Completed

NCT Number: NCT06673888

Assessment of Alkasite Restorative Material Versus Resin Modified Glass Ionomer in Class V Cavities: A 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?

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Key information

Age range

30 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Cairo University

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • • 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.

Exclusion criteria

  • • 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.
  • Non-vital tooth.
  • Signs of pathological wear.
  • Endodontically treated tooth.
  • Severe periodontal affection or tooth indicated for extraction.

Treatment and study plan

Resin modified glass ionomer

Other

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 material

Other

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.

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 5, 2024
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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