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Active, not recruitingNCT06375837Updated Dec 3, 2025

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

An interventional study of an alkasite-based restorative material and hybrid resin composite in Tooth Diseases, sponsored by Hacettepe University. Active, not recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-03.

Sponsored by Hacettepe University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
33
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Tooth Diseases

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03

In context

Tooth Diseases

79 studies on the registry are indexed under Tooth Diseases; 11 are open to participants now.

This study's enrollment of 33 is below the median of 49 across 63 interventional studies indexed under Tooth Diseases.

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Lead sponsor

Hacettepe University is the lead sponsor of 1,007 studies on the registry; 214 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
33 participants (actual)

Study arms

  • Experimental
    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.

    Device: an alkasite-based restorative material

  • Experimental
    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.

    Device: hybrid resin composite

  • Experimental
    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.

    Device: a highly filled flowable resin composite

Interventions

  • Devicean alkasite-based restorative material

    Cention N

  • Devicehybrid resin composite

    Gradia Direct Anterior

  • Devicea highly filled flowable resin composite

    G-aenial Universal Flo

06

What researchers measure

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.

    Time frame: two years

Secondary outcomes

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

    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.

    Time frame: two years

Other outcomes

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

    Two year results according to FDI criteria. (Biological properties) The evaluations will be carried out using FDI criteria. Biological 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.

    Time frame: two years

07

Study locations

1 site
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06375837
Responsible party
Dr. Fatma Dilşad Öz (Assoc. Prof. Dr., Hacettepe University) — Principal investigator
First posted
Apr 19, 2024
Start date
Apr 15, 2024
Primary completion
Jun 15, 2024
Completion
Jun 15, 2026 (estimated)
Last update
Dec 3, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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