Adhese One F Upgrade in Direct Filling Therapy

March 13, 2025 updated by: Ivoclar Vivadent AG

Clinical Evaluation of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ivoclar Vivadent AG

Investigators

  • Principal Investigator: Arnd Peschke, Dr., Ivoclar Vivadent AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

September 9, 2015

Study Registration Dates

First Submitted

June 20, 2014

First Submitted That Met QC Criteria

June 25, 2014

First Posted (Estimated)

June 26, 2014

Study Record Updates

Last Update Posted (Actual)

April 1, 2025

Last Update Submitted That Met QC Criteria

March 13, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AOFU 2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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