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

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06375837
Enrollment
33
Registered
2024-04-19
Start date
2024-04-15
Completion date
2026-06-15
Last updated
2025-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tooth Diseases

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.

Interventions

DEVICEan alkasite-based restorative material

Cention N

DEVICEhybrid resin composite

Gradia Direct Anterior

DEVICEa highly filled flowable resin composite

G-aenial Universal Flo

Sponsors

Hacettepe University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Clinical performances of different restorative systems according to FDI criteria (Esthetic properties)two yearsTwo 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

MeasureTime frameDescription
Clinical performances of different restorative systems according to FDI criteria (Functional properties)two yearsTwo 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

MeasureTime frameDescription
Clinical performances of different restorative systems according to FDI criteria (Biological properties)two yearsTwo 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026