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

NCT06375837 | Active Not Recruiting

• 1 other identifier: bioactive-NCCLs
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Tooth Diseases

Outcome Measures

Primary Outcomes (1)

• Clinical performances of different restorative systems according to FDI criteria (Esthetic properties)

  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.

  two years

Secondary Outcomes (1)

• Clinical performances of different restorative systems according to FDI criteria (Functional properties)

  two years

Other Outcomes (1)

• Clinical performances of different restorative systems according to FDI criteria (Biological properties)

  two years

Study Arms (3)

an alkasite-based restorative material

EXPERIMENTAL

Cention N, Ivoclar Vivadent, Schaan, Liechtenstein (CN) The liquid and powder will be mixed and then applied according to manufacturer's instructions.

Device: an alkasite-based restorative material

hybrid resin composite

EXPERIMENTAL

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.

Device: hybrid resin composite

a highly filled flowable resin composite

EXPERIMENTAL

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.

Device: a highly filled flowable resin composite

Interventions

hybrid resin composite DEVICE

Gradia Direct Anterior

hybrid resin composite

a highly filled flowable resin composite DEVICE

G-aenial Universal Flo

a highly filled flowable resin composite

an alkasite-based restorative material DEVICE

Cention N

an alkasite-based restorative material

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tooth Diseases

Condition Hierarchy (Ancestors)

Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Dr.

Study Record Dates

• First Submitted: October 2, 2023
• First Posted: April 19, 2024
• Study Start: April 15, 2024
• Primary Completion: June 15, 2024
• Study Completion (Estimated): June 15, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)