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NCT Number: NCT06375837

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Tooth Diseases Stomatognathic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University

Ankara, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

an alkasite-based restorative material

Device

Cention N

hybrid resin composite

Device

Gradia Direct Anterior

a highly filled flowable resin composite

Device

G-aenial Universal Flo

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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.

Other outcomes

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

    Time frame: two years

    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.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

Comparative Evaluation of an Alkasite-based Restorative Material and Two Different Resin Composites in Non-carious Cervical Lesions

Important dates

Study start
2024
Primary completion
2024
Study completion
2026
First posted
Apr 19, 2024
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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