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

NCT06673888 | Completed

• 1 other identifier: Cention Forte Protocol
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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?

Conditions

Class V Dental Caries

Outcome Measures

Primary Outcomes (1)

• 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).

  12 months change from base line to six and 12 months.

Study Arms (2)

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

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.

Other: Resin modified glass ionomer

Interventions

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.

Resin Modified Glass Ionomer Restorative Material

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.

Alkasite-Based Resin Composite Restorative Material (Bioactive Material)

Eligibility Criteria

• Age: 30 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, Egypt

Location

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: Assistant lecturer

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: November 5, 2024
• Study Start: December 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)