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

H

Hacettepe University

Status

Active, not recruiting

Conditions

Tooth Diseases

Treatments

Device: an alkasite-based restorative material
Device: hybrid resin composite
Device: a highly filled flowable resin composite

Study type

Interventional

Funder types

Other

Identifiers

NCT06375837
bioactive-NCCLs

Details and patient eligibility

About

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.

Enrollment

33 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

33 participants in 3 patient groups

an alkasite-based restorative material
Experimental group
Description:
Cention N, Ivoclar Vivadent, Schaan, Liechtenstein (CN) The liquid and powder will be mixed and then applied according to manufacturer's instructions.
Treatment:
Device: an alkasite-based restorative material
hybrid resin composite
Experimental group
Description:
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.
Treatment:
Device: hybrid resin composite
a highly filled flowable resin composite
Experimental group
Description:
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.
Treatment:
Device: a highly filled flowable resin composite

Trial contacts and locations

1

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Central trial contact

Fatma Oz

Data sourced from clinicaltrials.gov

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