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

NCT ID: NCT06369779

Last Updated: 2025-10-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-13
• Study Completion Date: 2030-12-31

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.

Conditions

Insufficient Dental Filling or Primary Caries (Class I or II Cavities in Premolars or Molars)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Test group (TM Fill in combination with TM Flow)

TM Fill an TM Flow are used for restoration of class I and class II cavities

Group Type: EXPERIMENTAL

TM Fill in combination with TM Flow

Intervention Type: DEVICE

The newly developed resin composites (TM Flow in combination with TM Fill) will be used for the restoration of class I and II cavities (3 seconds light-curing mode, 3000 milliwatt per square centimeter).

Interventions

TM Fill in combination with TM Flow

The newly developed resin composites (TM Flow in combination with TM Fill) will be used for the restoration of class I and II cavities (3 seconds light-curing mode, 3000 milliwatt per square centimeter).

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ivoclar Vivadent AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ivoclar Vivadent AG

Schaan, Liechtenstein, Liechtenstein

Countries

Liechtenstein

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

OTCS 36406866

Identifier Type: -

Identifier Source: org_study_id