Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06238999

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Non-carious Cervical Lesions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ivoclar Vivadent AG

Schaan, Liechtenstein, 9494

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Restoration of non-carious cervical lesions

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.

Primary outcomes

  1. Postoperative Hypersensitivity

    Time frame: 1 month

    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

Secondary outcomes

  1. 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

    Time frame: 5 years

    will be assessed acooriding to FDI criteria

Sponsors and collaborators

Lead sponsor

Ivoclar Vivadent AG

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2029
First posted
Feb 2, 2024
Registry last updated
Oct 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.