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Adhese One F Upgrade in Direct Filling Therapy

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ClinicalTrials.gov Identifier: NCT02175368
Recruitment Status : Completed
First Posted : June 26, 2014
Results First Posted : April 9, 2018
Last Update Posted : April 9, 2019
Sponsor:
Information provided by (Responsible Party):
Ivoclar Vivadent AG

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Dental Adhesive Device: Adhese One F Upgrade Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of AdheSE One F Upgrade in Direct Filling Therapy
Study Start Date : June 2012
Actual Primary Completion Date : June 2015
Actual Study Completion Date : September 9, 2015

Arm Intervention/treatment
Experimental: Adhese One F Upgrade
Adhese One F Upgrade (AOFU) is administered after phosphoric acid etching (etch-and-rinse protocol).
Device: Adhese One F Upgrade



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02175368


Sponsors and Collaborators
Ivoclar Vivadent AG
Investigators
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Principal Investigator: Arnd Peschke, Dr. Ivoclar Vivadent AG
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Responsible Party: Ivoclar Vivadent AG
ClinicalTrials.gov Identifier: NCT02175368    
Other Study ID Numbers: AOFU 2012
First Posted: June 26, 2014    Key Record Dates
Results First Posted: April 9, 2018
Last Update Posted: April 9, 2019
Last Verified: March 2019
Keywords provided by Ivoclar Vivadent AG:
total etch protocol
direct filling therapy