Split-mouth Study of a New Flowable Composite in Non-carious Cervical Lesions

Ivoclar Vivadent

Status: Active, not recruiting

Conditions: Non-carious Cervical Lesions

Treatments: Device: Restoration of non-carious cervical lesions

Study type: Interventional

Funder types: Industry

Identifiers

NCT06238999

OTCS 36427036

Details and patient eligibility

About

The overall objective of this clinical investigation is to evaluate the clinical safety and performance of the new flowable composite TM Flow for treatment of non-carious cervical lesions. Each participant receives two different fillings (test- and control material) in two different teeth. The fillings are assessed according to selected FDI criteria at baseline (7-10 days after filling placement) and after 1, 6, 12, 24, 36 and 60 months.

Enrollment: 66 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Informed Consent signed by the subject
• Age: 18-65 years
• 2 NCCL needing treatment, comparable in extend and size, preferably located in different quadrants
• Vital teeth, regular sensitivity
• Sufficient language skills
• No active periodontitis
• Preoperative VAS values < 3 regarding tooth sensitivity on biting. Tooth sensitivity on temperature or touching (tooth brushing, probing) originating in the area of the NCCL is accepted.
• Subject wishes to have a restoration as part of the study (written declaration of consent after detailed explanation)

Exclusion criteria

• Not completed hygiene phase or poor oral hygiene
• Sufficient isolation of the cavity not possible
• Patients with a proven allergy to one of the ingredients (methacrylates)
• Patients with severe systemic diseases
• Periodontally insufficient dentition
• Pregnancy
• Part of the development project team of TM Flow
• Staff of the study management team
• Staff of the internal clinic

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

66 participants in 2 patient groups

Test goup TM Flow

Experimental group

Description:

The newly developed flowable composite TM Flow will be used for the restoration of NCCLs in the test group. The treatment workflow is very similar to other flowable composites.

Treatment:

Device: Restoration of non-carious cervical lesions

Control group Tetric EvoFlow

Active Comparator group

Description:

The well-established Tetric EvoFlow will be used for the restorations of NCCLs in the control group.

Treatment:

Device: Restoration of non-carious cervical lesions