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Clinical Trials/NCT06375837
NCT06375837
Active, not recruiting
Not Applicable

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

Hacettepe University1 site in 1 country33 target enrollmentApril 15, 2024
ConditionsTooth Diseases

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tooth Diseases
Sponsor
Hacettepe University
Enrollment
33
Locations
1
Primary Endpoint
Clinical performances of different restorative systems according to FDI criteria (Esthetic properties)
Status
Active, not recruiting
Last Updated
5 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 15, 2024
End Date
June 15, 2026
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Fatma Dilşad Öz

Assoc. Prof. Dr.

Hacettepe University

Eligibility Criteria

Inclusion Criteria

  • Age range will be 18 to
  • 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

Outcomes

Primary Outcomes

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

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

Study Sites (1)

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