Clinical Evaluation of a New Flowable Composite for Direct Restorative Treatment of Non-carious Cervical Lesions: A Prospective Randomized Split-mouth Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Ivoclar Vivadent AG
- Enrollment
- 66
- Locations
- 2
- Primary Endpoint
- Postoperative Hypersensitivity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Restoration of non-carious cervical lesions (Device)
Control group Tetric EvoFlow
The well-established Tetric EvoFlow will be used for the restorations of NCCLs in the control group.
Intervention: Restoration of non-carious cervical lesions (Device)
Outcomes
Primary Outcomes
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
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
- 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)