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 criteria at baseline (7-10 days after placement of filling) and after 1, 6, 12, 24, 36 and 60 months.

Study Overview

• Status: Not yet recruiting
• Conditions: Class I or II Cavities in Premolars or Molars
• Intervention / Treatment: Device: TM Fill and TM Flow

• Study Type: Interventional
• Enrollment (Estimated): 65
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test group (TM Fill and TM Flow); TM Fill an TM Flow are used for restoration of class I and class II cavities	Device: TM Fill and TM Flow; The newly developed resin composites TM Flow and TM Fill will be used for the restoration of class I and II cavities (3 seconds light-curing mode, 3000 mW/cm2).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative hypersensitivity	will be assessed acooriding to FDI criteria	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	will be assessed acooriding to FDI criteria	5 years

Collaborators and Investigators

• Sponsor: Ivoclar Vivadent AG

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: April 12, 2024
• First Submitted That Met QC Criteria: April 12, 2024
• First Posted (Actual): April 17, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 12, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: OTCS 36406866

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No