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

Last updated: January 10, 2025
Sponsor: Ivoclar Vivadent AG
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

N/A

Treatment

TM Fill and TM Flow

TM Fill in combination with TM Flow

Clinical Study ID

NCT06369779
OTCS 36406866
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Informed Consent signed by the subject

  • Age: 18-65 years

  • Indication Class I or II direct restorations in premolars or molars (Replacement ofinsufficient fillings due to secondary caries, fractures, insufficient marginaladaptation, 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 andbiting

Exclusion

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

Total Participants: 65
Treatment Group(s): 2
Primary Treatment: TM Fill and TM Flow
Phase:
Study Start date:
May 13, 2024
Estimated Completion Date:
December 31, 2030

Connect with a study center

  • Ivoclar Vivadent AG

    Schaan, 9494
    Liechtenstein

    Site Not Available

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