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

Clinical Evaluation of a New Flowable Composite for Direct Restorative Treatment of Non-carious Cervical Lesions: A Prospective Randomized Split-mouth Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Non-carious Cervical Lesions
• Intervention / Treatment: Device: Restoration of non-carious cervical lesions

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Liechtenstein
  • Liechtenstein
    • Schaan, Liechtenstein, Liechtenstein, 9494
      • Ivoclar Vivadent AG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.
Active Comparator: Control group Tetric EvoFlow; The well-established Tetric EvoFlow will be used for the restorations of NCCLs in the control group.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Hypersensitivity	assessed by tests with thermal stimuli and occlusal forces (during biting) determined by VAS (Visual Analog Scale, 0 "No pain at all" - 10 "The worst pain imaginable") following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" FDI 1: no complaint FDI 2: minor complaint FDI 3: distinct pain FDI 4: persistent pain for prolonged period of time FDI 5: treatment unavoidable	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of Functional (e.g. Fracture of the Material and Retention), Biological (e.g. Caries at Restoration Margins) and Aesthetic (e.g. Color Match) Properties of the Restorations	will be assessed acooriding to FDI criteria	5 years

Collaborators and Investigators

• Sponsor: Ivoclar Vivadent AG

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2024
• Primary Completion (Actual): April 30, 2024
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: January 26, 2024
• First Submitted That Met QC Criteria: January 26, 2024
• First Posted (Actual): February 2, 2024

Study Record Updates

• Last Update Posted (Estimated): October 23, 2025
• Last Update Submitted That Met QC Criteria: September 26, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Uterine Cervical Diseases
• Other Study ID Numbers: OTCS 36427036

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No