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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06375837
Other study ID # bioactive-NCCLs
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 15, 2024
Est. completion date June 15, 2026

Study information

Verified date April 2024
Source Hacettepe University
Contact Fatma Oz
Phone 903123052270
Email dilsadoz@hacettepe.edu.tr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 33
Est. completion date June 15, 2026
Est. primary completion date June 15, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
an alkasite-based restorative material
Cention N
hybrid resin composite
Gradia Direct Anterior
a highly filled flowable resin composite
G-aenial Universal Flo

Locations

Country Name City State
Turkey Hacettepe University Ankara

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Other 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. two years
Primary 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. two years
Secondary 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. two years
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