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Completed

NCT Number: NCT03221660

Clinical Investigation of the F-Composite 2 System in Direct Filling Therapy

The objective of this study is to evaluate the clinical performance of F-Composite 2 system in Class I and Class II cavities in permanent teeth.

The materials of the system can be polymerized in short time with a curing light which is part of the system.

The study will be carried out as a prospective study, with evaluation of the restorations after 7-10 days (baseline), at 6 months, at 12 months, at 24 months and 60 months according to defined criteria.

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Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases Unsatisfactory or Defective Restoration of Tooth

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ivoclar Vivadent

Schaan, 9494, Liechtenstein

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Indication for direct filling of Class I or II with permanent premolars or permanent molars
  • replacement of insufficient fillings (e.g., due to edge caries, filling fracture, Lack of quality of the surface, lack of aesthetics, undesirable filling material, leaky edge, edge gap, etc.)
  • extensive primary caries
  • Vital tooth (cold test)
  • One-, two- or three-surface fillings in the lateral tooth area, with a maximum of 25% single-faced (Class I) with antagonists.
  • The occlusal area of the filling must be at least 1/3 of the total area of the filling tooth. This criterion is estimated.
  • Patient wishes to receive care within the framework of the study (written consent after detailed elucidation and study of patient information).
  • Maximum of 2 restorations per patient.
  • Preoperative complaints on the tooth to be restored (maximum 3 on visual Analog scale (0 = complaint-free, 10 = maximum possible pain) to temperature or bite sensitivity
  • Sufficient language skills

Exclusion criteria

  • Unfinished hygiene phase or poor oral hygiene
  • Sufficient draining of the operating field is not possible
  • Patients with proven allergy to one of the ingredients of the materials used
  • Patient has allergies to local anesthetic agents Ultracain DS (active substance: articaine; Vasoconstrictor), if anesthesia is desired
  • Patients with severe systemic diseases
  • Devital or pulpitic teeth
  • Periodontal insufficiency
  • Supplements with cusp attachments
  • open side bite
  • missing antagonist
  • Indication for direct capping
  • Pregnancy (women of childbearing age receive a free pregnancy test for self application, the negative result of which is shown with her confirmed consent).

Treatment and study plan

F-Composite 2 system

Device

Procedures will be done using local anesthesia (if the patients wants that). The cavity is prepared according to the principles of the adhesive technique. First the adhesive will be applied and polymerized, afterwards the flowable resin-based restorative material will be applied and polymerized and then the sculptable resin-based restorative material will be applied and polymerized; all materials will be light-cured within short time with an experimental curing light.

Primary outcomes

  1. Percentage of Restored Teeth With Postoperative Sensitivity

    Time frame: 1 month

    The postoperative sensitivity is assessed by tests with thermal stimuli and occlusal forces (during biting) determined by VAS (Visual Analog Scale, from 0 "no pain" to 10 "maximum pain") following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable".

    A maximum of 10% postoperative hypersensitivities are defined as acceptable after one month.

Secondary outcomes

  1. Number of Restored Teeth With Loss of Vitality

    Time frame: 12 months

    The loss of vitality of restored teeth is assessed by a cold stimuli test (cotton pellet and refrigerating spray) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable".

    A maximum of 1 tooth with loss of vitality within 12 months is determined to be acceptable.

  2. Replacement of Filling

    Time frame: 2 years

    maximum of 3 fillings which have to be replaced due to a lack of quality after 2 years

Other outcomes

  1. FDI 1 Surface Luster, FDI Score 1-5

    Time frame: 60 months

    assessed on patient teeth (comparing surface of filling with enamel) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"

  2. FDI 2 Surface Staining, FDI Score 1-5

    Time frame: 60 month

    assessed on patient teeth by checking surface staining of restoration following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"

  3. FDI 3 Translucency, FDI Score 1-5

    Time frame: 60 month

    assessed on patient teeth by checking differences in shade and translucency following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"

  4. FDI 5 Retention/Fracture of Restorations, FDI Score 1-5

    Time frame: 60 month

    assessed on patient teeth (checking irestorations for fractures, cracks, small hairline cracks, chip fractures, material damage) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"

  5. FDI 6 Marginal Adaption, FDI Score 1-5

    Time frame: 60 month

    assessed on patient teeth (checking for hamonious outline, gaps and white/discolored lines)) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"

  6. FDI 10 Patient's View, FDI Scire 1-5

    Time frame: 60 month

    assessed by discussion with the patient (satisfied with esthetics and function) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"

  7. FDI 11 Postoperative Hypersensitivity and Tooth Vitality, FDI Scores 1-5

    Time frame: 60 month

    Hypersensitivity was assessed by tests with thermal stimuli and occlusal forces (during biting) determined by VAS (Visual Analog Scale) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable".

    Tooth vtality assessed by a cold stimuli test on the patient teeth (cotton pellet and refrigerating spray) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"

  8. FDI 12 Recurrence of Caries (CAR), Erosion, Abfraction, FDI Scores 1-5

    Time frame: 60 month

    assessed on patient teeth (primary caries, areas of demineralization erosion or abfraction)) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"

  9. FDI 13 Tooth Integrity, FDI Scores 1-5

    Time frame: 60 month

    assessed on patient teeth by checking tooth integrity (looking for enamel cracks, tooth fractures) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"

Sponsors and collaborators

Lead sponsor

Ivoclar Vivadent AG

Industry

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2023
First posted
Jul 18, 2017
Registry last updated
Apr 13, 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.

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