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Completed

NCT Number: NCT01925040

Comparison of 2 Different Resin Based Filling Materials in Posterior Teeth - a Multicenter Study

The purpose of this study is to compare the clinical performance of a new resin based filling material to an established resin-based filling material in posterior teeth at 2 different study centers.

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Key information

Conditions

Caries Unsatisfactory or Defective Restoration of Tooth

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical School Hannover, Hanover, Germany

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About this study

The objective of this study is to compare the performance of the composite resin Venus Pearl and a commercially available control composite material for the restoration of class II-cavities. Primary endpoints of the study are a mean score for each patient calculated from aesthetic, functional attribute and biological parameters. Secondary endpoints are the evaluation of secondary caries, plaque accumulation and gingival reactions and the comparison of the primary score at week 1, month 6, month 12 and month 24 after restoration. Beside this, the single components of the three categories of the primary endpoints will be compared. The study will be executed as a multi-center (Oregon Health & Science University, Portland, OR, USA and Medical School Hannover, Hannover, Germany), single-blinded and randomized clinical investigation. 90 comparable cavities per study site will be treated (45 cavities for each material at each site).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients should be 18 years and older.
  • Study teeth should have an interproximal (Class II) carious lesion or an existing defective class II restoration requiring restorative therapy on premolars or molars.
  • The maximum cavity depth determined by the radiograph will be D2 (Tyas classification).
  • The teeth included in the study need to have a proximal contact with the adjacent tooth and be in occlusion with the opposing dentition.
  • The teeth included in the study should be vital with no signs of pulpal pathology.
  • Patients that report brushing regularly without severe gingival inflammation and/or extensive caries.
  • Patients should have no allergies or systemic diseases which inhibit the treatment.
  • Patients should have voluntary participation and sign a written informed consent form.
  • Patients should be willing to participate in the recall/re-examination appointments.

Exclusion criteria

  • Simultaneous participation in another study about dental restorative materials.
  • Written informed consent form not signed.
  • Nonvital pulp / periapical lesion.
  • Insufficient oral hygiene despite detailed instructions.
  • Pregnancy/ breast feeding before placement of the study restoration.
  • Minors.
  • Severe malocclusion/ malalignment/ traumatic occlusion/ bruxism.
  • Known allergy to any components present in any of the materials that are used for this study.
  • Unclear mucosal alterations, e.g. oral lichenoid reactions/lesions.
  • Severe medical complications (organ transplants, cancer, immune-compromised, long-term antibiotic or steroid therapy).
  • Infectious diseases such as HIV/Aids, Hepatitis, etc.
  • Application of bleaching products less than 14 days before placement of the restoration.
  • Orthodontic treatment during the study.
  • Xerostomia.
  • Untreated periodontal diseases.
  • Rampant or extensive caries present.
  • Systemic diseases with potential oral manifestation.
  • Sufficient isolation according to the criteria of adhesive techniques not possible, e.g. application of rubber dam.
  • Direct adhesive restoration not indicated.
  • Replacement of more than one cusp indicated.
  • Dental fears patients.

Treatment and study plan

Placement of restoration

Device

Placement of restorations

Primary outcomes

  1. Score for Surface Luster

    Time frame: 2 years

    The primary endpoint will be a mean score calculated as following: There are three aspects to be assessed: aesthetic, functional attribute and biological parameters.

    Score of esthetic properties:

    1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for surface luster

  2. Score for Surface Staining

    Time frame: 2 years

    The primary endpoint will be a mean score calculated as following: There are three aspects to be assessed: aesthetic, functional attribute and biological parameters.

    Score of esthetic properties:

    1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for surface staining

  3. Score for Marginal Discoloration

    Time frame: 2 years

    The primary endpoint will be a mean score calculated as following: There are three aspects to be assessed: aesthetic, functional attribute and biological parameters.

    Score of esthetic properties:

    1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for marginal discoloration

  4. Score for Fracture and Retention

    Time frame: 2 years

    The primary endpoint will be a mean score calculated as following: There are three aspects to be assessed: aesthetic, functional attribute and biological parameters.

    Score of functional properties:

    1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for fracture and retention

  5. Score for Color Match

    Time frame: 2 years

    The primary endpoint will be a mean score calculated as following: There are three aspects to be assessed: aesthetic, functional attribute and biological parameters.

    Score of esthetic properties:

    1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for color match

  6. Score for Esthetic Anatomical Form

    Time frame: 2 years

    The primary endpoint will be a mean score calculated as following: There are three aspects to be assessed: aesthetic, functional attribute and biological parameters.

    Score of esthetic properties:

    1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for esthetic anatomical form

  7. Score for Marginal Adaptation

    Time frame: 2 years

    The primary endpoint will be a mean score calculated as following: There are three aspects to be assessed: aesthetic, functional attribute and biological parameters.

    Score of functional properties:

    1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for marginal adaptation

  8. Score for Abrasion

    Time frame: 2 years

    The primary endpoint will be a mean score calculated as following: There are three aspects to be assessed: aesthetic, functional attribute and biological parameters.

    Score of functional properties:

    1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for abrasion

  9. Score for Approximal Anatomical Form

    Time frame: 2 years

    The primary endpoint will be a mean score calculated as following: There are three aspects to be assessed: aesthetic, functional attribute and biological parameters.

    Score of functional properties:

    1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for approximal anatomical form

  10. Score for Satisfaction of Patient

    Time frame: 2 years

    The primary endpoint will be a mean score calculated as following: There are three aspects to be assessed: aesthetic, functional attribute and biological parameters.

    Score of functional properties:

    1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for satisfaction of patient

  11. Score for Post-operative Hypersensitivity

    Time frame: 2 years

    The primary endpoint will be a mean score calculated as following: There are three aspects to be assessed: aesthetic, functional attribute and biological parameters.

    Score of biological properties:

    1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for post-operative hypersensitivity

  12. Score for Caries, Erosion

    Time frame: 2 years

    The primary endpoint will be a mean score calculated as following: There are three aspects to be assessed: aesthetic, functional attribute and biological parameters.

    Score of biological properties:

    1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for caries, erosion

  13. Score for "Tooth Integrity"

    Time frame: 2 years

    The primary endpoint will be a mean score calculated as following: There are three aspects to be assessed: aesthetic, functional attribute and biological parameters.

    Score of biological properties:

    1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for "tooth integrity"

  14. Score for Parodontal Reaction

    Time frame: 2 years

    The primary endpoint will be a mean score calculated as following: There are three aspects to be assessed: aesthetic, functional attribute and biological parameters.

    Score of biological properties:

    1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for parodontal reaction

  15. Score for Adjacent Mucosa

    Time frame: 2 years

    The primary endpoint will be a mean score calculated as following: There are three aspects to be assessed: aesthetic, functional attribute and biological parameters.

    Score of biological properties:

    1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for adjacent mucosa

Sponsors and collaborators

Lead sponsor

Heraeus Kulzer GmbH

Industry

Registry information

Official study title

Clinical Investigation of a New Nanohybrid Resin Composite Venus Pearl in Class 2 Cavities- a Multi-center Study

Important dates

Study start
2013
Primary completion
2022
Study completion
2022
First posted
Aug 19, 2013
Registry last updated
Oct 28, 2024

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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