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OpenTrials
Completed

NCT Number: NCT02175368

Adhese One F Upgrade in Direct Filling Therapy

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.

Completed

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Key information

Conditions

Dental Adhesive

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Adhese One F Upgrade

Device

Primary outcomes

  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 outcomes

  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 (patients with satisfactory clinical outcome) or not acceptable (patients with unsatisfactory clinical outcome).

Sponsors and collaborators

Lead sponsor

Ivoclar Vivadent AG

Industry

Registry information

Official study title

Clinical Evaluation of AdheSE One F Upgrade in Direct Filling Therapy

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jun 26, 2014
Registry last updated
Apr 1, 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.