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OpenTrials
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NCT Number: NCT06369779

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ivoclar Vivadent AG

Schaan, Liechtenstein, 9494

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TM Fill in combination with TM Flow

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).

Primary outcomes

  1. Postoperative Hypersensitivity

    Time frame: 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 outcomes

  1. 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

    Time frame: 5 years

    will be assessed according to FDI criteria (grade 1-5)

Sponsors and collaborators

Lead sponsor

Ivoclar Vivadent AG

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2030
First posted
Apr 17, 2024
Registry last updated
Oct 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.