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Clinical Trials/NCT06375837
NCT06375837Active, not recruitingNot 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 enrollmentStarted: April 15, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
33
Locations
1
Primary Endpoint
Clinical performances of different restorative systems according to FDI criteria (Esthetic properties)

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dr. Fatma Dilşad Öz

Assoc. Prof. Dr.

Hacettepe University

Study Sites (1)

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