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

Not Applicable

Active, not recruiting

• Conditions: Non-carious Cervical Lesions

• Registration Number: NCT06238999
• Lead Sponsor: Ivoclar Vivadent AG

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-26
• Study First Submitted QC: 2024-01-26
• Study First Posted: 2024-02-02
• Study Start: 2024-02-20
• Primary Completion: 2024-04-30
• Status Verified: 2025-05
• Results First Submitted: 2025-05-14
• Results First Submitted QC: 2025-05-14
• Last Update Submitted: 2025-05-14
• Results First Posted: 2025-05-31
• Last Update Posted: 2025-05-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 66

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Postoperative Hypersensitivity	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"

Secondary Outcome Measures

Name	Time	Method
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	5 years	will be assessed acooriding to FDI criteria

Trial Locations

Locations (1)

Ivoclar Vivadent AG; 🇱🇮 Schaan, Liechtenstein