Comparative Evaluation of an Alkasite-based Restorative Material and Two Different Resin Composites

Not Applicable

Active, not recruiting

• Conditions: Tooth Diseases
• Interventions: Device: an alkasite-based restorative material; Device: hybrid resin composite; Device: a highly filled flowable resin composite

• Registration Number: NCT06375837
• Lead Sponsor: Hacettepe University

Brief Summary

The clinical performance of an an alkasite-based restorative material and two different resin composites will be evaluated and compared in non-carious cervical lesions. After recruiting participants with at least three non-carious cervical lesions, all restorations will be placed by a single clinician. Lesions will be divided in three groups: an alkasite-based restorative material (Cention N, Ivoclar Vivadent, Schaan, Liechtenstein (CN)), hybrid resin composite (Gradia Direct Anterior, GC, Tokyo, Japan (GD)) and a highly filled flowable resin composite ((G-aenial Universal Flo, GC, Tokyo, Japan (GF)). All restorative procedures will be conducted according to manufacturers' instructions. Restorations will be scored using FDI criteria. Descriptive statistics will be performed using chi-square tests.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-02
• Study Start: 2024-04-15
• Study First Submitted QC: 2024-04-16
• Study First Posted: 2024-04-19
• Primary Completion: 2024-06-15
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-22
• Study Completion: 2026-06-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• Age range will be 18 to 65.
• They will be required to have at least three NCCLs needed restoration in different teeth.
• All the NCCLs selected will be in similar sizes.

Exclusion Criteria

• Patients with severe periodontal disease
• Patients with rampant, uncontrolled caries
• Patients with xerostomia
• Patients with serious medical problems preventing them from attending review visits
• Patients with poor gingival health
• Patients with heavy bruxism
• Patients with removable partial dentures
• Patients undergoing bleaching treatment or orthodontic treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
an alkasite-based restorative material	an alkasite-based restorative material	Cention N, Ivoclar Vivadent, Schaan, Liechtenstein (CN) The liquid and powder will be mixed and then applied according to manufacturer's instructions.
hybrid resin composite	hybrid resin composite	Gradia Direct Anterior, GC, Tokyo, Japan (GR) After applying 37% orthophosphoric acid to the enamel of the lesions for 30 seconds and to the dentin for 15 seconds, the acid will be washed with water and then dried with light air. A universal adhesive (G-Premio Bond, GC, Tokyo, Japan) and then the composite will be applied according to the manufacturer's instructions.
a highly filled flowable resin composite	a highly filled flowable resin composite	G-aenial Universal Flo, GC, Tokyo, Japan (GF) After applying 37% orthophosphoric acid to the enamel of the lesions for 30 seconds and to the dentin for 15 seconds, the acid will be washed with water and then dried with light air. A universal adhesive (G-Premio Bond, GC, Tokyo, Japan) and then the composite will be applied according to the manufacturer's instructions.

Primary Outcome Measures

Name	Time	Method
Clinical performances of different restorative systems according to FDI criteria (Esthetic properties)	two years	Two year results according to FDI criteria. (Esthetic properties) The evaluations will be carried out using FDI criteria. Esthetic properties will be examined. Five scores will be given for each restoration: (1) Clinically excellent / very good, (2) Clinically good, (3) Clinically sufficient/satisfactory, (4) Clinically unsatisfactory, (5) Clinically poor.The data obtained for groups will be compared at each visit.

Secondary Outcome Measures

Name	Time	Method
Clinical performances of different restorative systems according to FDI criteria (Functional properties)	two years	Two year results according to FDI criteria. (Functional properties) The evaluations will be carried out using FDI criteria. Functional properties will be examined.Five scores will be given for each restoration: (1) Clinically excellent / very good, (2) Clinically good, (3) Clinically sufficient/satisfactory, (4) Clinically unsatisfactory, (5) Clinically poor.The data obtained for groups will be compared at each visit.

Trial Locations

Locations (1)

Hacettepe University; 🇹🇷 Ankara, Turkey