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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Insufficient Dental Filling or Primary Caries (Class I or II Cavities in Premolars or Molars)
- Sponsor
- Ivoclar Vivadent AG
- Enrollment
- 65
- Locations
- 1
- Primary Endpoint
- Postoperative Hypersensitivity
- Status
- Active, not recruiting
- Last Updated
- 6 months ago
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 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.
Investigators
Eligibility Criteria
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
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
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)