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

NCT ID: NCT06375837

Last Updated: 2025-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-15

Study Completion Date

2026-06-15

Brief Summary

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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

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Conditions

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Tooth Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

hybrid resin composite

Intervention Type DEVICE

Gradia Direct Anterior

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.

Group Type EXPERIMENTAL

a highly filled flowable resin composite

Intervention Type DEVICE

G-aenial Universal Flo

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.

Group Type EXPERIMENTAL

an alkasite-based restorative material

Intervention Type DEVICE

Cention N

Interventions

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an alkasite-based restorative material

Cention N

Intervention Type DEVICE

hybrid resin composite

Gradia Direct Anterior

Intervention Type DEVICE

a highly filled flowable resin composite

G-aenial Universal Flo

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Dr. Fatma Dilşad Öz

Assoc. Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hacettepe University

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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bioactive-NCCLs

Identifier Type: -

Identifier Source: org_study_id

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