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

Tooth Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06375837
• Other study ID #: bioactive-NCCLs
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Tooth Diseases

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