Clinical Evaluation of a New Flowable and a New Sculptable Universal Bulk-fill Composite for Direct Restorative Treatment

Clinical Evaluation of Class I and II Cavities Restored With the Combination of a New Flowable and a New Sculptable Universal Bulk-fill Composite: A Prospective Single Arm Study

The overall objective of this clinical investigation is to evaluate the clinical safety and performance of the new flowable composite TM Flow and the new sculptable composite TM Fill for restoration of class I and class II cavities. The fillings are assessed according to selected FDI (Fédération Dentaire Internationale) criteria at baseline (7-10 days after placement of filling) and after 1, 6, 12, 24, 36 and 60 months.

Inclusion Criteria:

• Informed Consent signed by the subject
• Age: 18-65 years
• Indication Class I or II direct restorations in premolars or molars (Replacement of insufficient fillings due to secondary caries, fractures, insufficient marginal adaptation, loss of filling or primary caries)
• Cavity width must be at least half of the cusp tip distance
• Vital teeth, regular sensitivity
• Sufficient language skills
• No active periodontits
• Preoperative VAS (visual analogue scale) values < 3 regarding tooth sensitivity and biting

Exclusion Criteria:

• Sufficient isolation of the cavity not possible
• Not completed hygiene phase or poor oral hygiene
• Missing antagonist, non-occlusion
• Missing tooth adjacent to the tooth to be treated
• Restorations replacing more than 1 cusp
• Caries profunda or very deep cavity
• Patients with a proven allergy to ingredients of the used materials (methacrylates) or local anesthetics (Articain, sulfite)
• Patients with severe systemic diseases
• Pregnancy