Adhese One F Upgrade in Direct Filling Therapy

Overview

Investigation on the clinical performance of a new dental adhesive when used in direct filling therapy after phosphoric acid etching. Hypothesis: The new adhesive shows an acceptable clinical performance and allows a good filling quality.

Full Title of Study: “Clinical Evaluation of AdheSE One F Upgrade in Direct Filling Therapy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2015

Interventions

  • Device: Adhese One F Upgrade

Arms, Groups and Cohorts

  • Experimental: Adhese One F Upgrade
    • Adhese One F Upgrade (AOFU) is administered after phosphoric acid etching (etch-and-rinse protocol).

Clinical Trial Outcome Measures

Primary Measures

  • Number of Participants With Clinical Success
    • Time Frame: 1 week
    • Clinical success is defined as no postoperative hypersensitivity and no loss of the restoration.

Secondary Measures

  • Clinical Quality
    • Time Frame: 3 years
    • The clinical quality of the restorations will be evaluated according to semi-quantitative clinical evaluation (SQUACE) criteria and compared at all time points and at the end of the study. SQUACE is a published semi-quantitative method to evaluate the clinical success of dental restorations that is based on the commonly used USPHS criteria. The quality of the restoration is rated according to the SQUACE scale and classified as acceptable or not acceptable.

Participating in This Clinical Trial

Inclusion Criteria

  • indication for class I or II filling – max. 2 restorations per patient – vital teeth – sufficient language skills Exclusion Criteria:

  • dry working field cannot be established – if the patient is known to be allergic to any of the materials' ingredients – severe systemic diseases – pregnancy – non-vital or pulpitic teeth – indication for indirect restoration

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ivoclar Vivadent AG
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Arnd Peschke, Dr., Principal Investigator, Ivoclar Vivadent AG

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