Split-mouth Study of a New Flowable Composite in Non-carious Cervical Lesions (NCT06238999) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Split-mouth Study of a New Flowable Composite in Non-carious Cervical Lesions
Liechtenstein66 participantsStarted 2024-02-20
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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