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)

• 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

Study Timeline

• Study First Submitted: 2024-04-12
• Study First Submitted QC: 2024-04-12
• Study First Posted: 2024-04-17
• Study Start: 2024-05-13
• Primary Completion: 2024-08-12
• Results First Submitted: 2025-05-14
• Results First Submitted QC: 2025-05-14
• Results First Posted: 2025-05-31
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-28
• Last Update Posted: 2025-08-06
• Study Completion: 2030-12-01

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

Primary Outcome Measures

Name	Time	Method
Postoperative Hypersensitivity	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 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