Clinical Evaluation of a New Flowable and a New Sculptable Universal Bulk-fill Composite for Direct Restorative Treatment
Not Applicable
Active, not recruiting
- Conditions
- Insufficient Dental Filling or Primary Caries (Class I or II Cavities in Premolars or Molars)
- Interventions
- Device: TM Fill in combination with TM Flow
- Registration Number
- NCT06369779
- Lead Sponsor
- Ivoclar Vivadent AG
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 65
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Test group (TM Fill in combination with TM Flow) TM Fill in combination with TM Flow TM Fill an TM Flow are used for restoration of class I and class II cavities
- Primary Outcome Measures
Name Time Method Postoperative hypersensitivity 1 month will be assessed according to FDI criteria (grade 1-5)
- Secondary Outcome Measures
Name Time Method 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 will be assessed according to FDI criteria (grade 1-5)
Trial Locations
- Locations (1)
Ivoclar Vivadent AG
🇱🇮Schaan, Liechtenstein