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

Non-carious Cervical Lesions Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06238999
• Other study ID #: OTCS 36427036
• Status: Recruiting
• Phase: N/A
• Start date: February 20, 2024
• Est. completion date: December 31, 2029

Study information

• Verified date: April 2024
• Source: Ivoclar Vivadent AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: December 31, 2029
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Non-carious Cervical Lesions
• Uterine Cervical Diseases

Intervention

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.

Locations

Country	Name	City	State
Liechtenstein	Ivoclar Vivadent AG	Schaan

Sponsors (1)

Lead Sponsor	Collaborator
Ivoclar Vivadent AG

Country where clinical trial is conducted

Liechtenstein, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative hypersensitivity	will be assessed acooriding to FDI criteria	1 month
Secondary	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