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

NCT06238999 | Active Not Recruiting Results

• 1 other identifier: OTCS 36427036
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 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

  5 years

Study Arms (2)

Test goup TM Flow

EXPERIMENTAL

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

Control group Tetric EvoFlow

ACTIVE COMPARATOR

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

Device: Restoration of non-carious cervical lesions

Interventions

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.

Control group Tetric EvoFlow; Test goup TM Flow

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed Consent signed by the subject
• Age: 18-65 years
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ivoclar Vivadent AG: lead

Study Sites (1)

Ivoclar Vivadent AG

Schaan, Liechtenstein, 9494, Liechtenstein

Location

Results Point of Contact

• Title: Team Leader Study Management
• Organization: Ivoclar Vivadent AG

patrizia.elkuch-hoch@ivoclar.com

+4232353780

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Split-Mouth Design

Study Record Dates

• First Submitted: January 26, 2024
• First Posted: February 2, 2024
• Study Start: February 20, 2024
• Primary Completion: April 30, 2024
• Study Completion (Estimated): December 31, 2029
• Last Updated: October 23, 2025
• Results First Posted: May 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

LI (1)