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

NCT ID: NCT06238999

Last Updated: 2025-10-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-20
• Study Completion Date: 2029-12-31

Brief Summary

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.

Conditions

Non-carious Cervical Lesions

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Test goup TM Flow

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.

Group Type: EXPERIMENTAL

Restoration of non-carious cervical lesions

Intervention Type: DEVICE

Non-carious cervical lesions will be treated with the experimental TM Flow or the well-established Tetric EvoFlow. The treatment workflow is very similar to other flowable composites.

Control group Tetric EvoFlow

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

Group Type: ACTIVE_COMPARATOR

Restoration of non-carious cervical lesions

Intervention Type: DEVICE

Non-carious cervical lesions will be treated with the experimental TM Flow or the well-established Tetric EvoFlow. The treatment workflow is very similar to other flowable composites.

Interventions

Restoration of non-carious cervical lesions

Non-carious cervical lesions will be treated with the experimental TM Flow or the well-established Tetric EvoFlow. The treatment workflow is very similar to other flowable composites.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ivoclar Vivadent AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ivoclar Vivadent AG

Schaan, Liechtenstein, Liechtenstein

Countries

Liechtenstein

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

OTCS 36427036

Identifier Type: -

Identifier Source: org_study_id