Dental AdhesiveNCT02175368
Adhese One F Upgrade in Direct Filling Therapy
A study testing Adhese One F Upgrade in people with Dental Adhesive, run by Ivoclar Vivadent AG.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dental Adhesive
- What is being tested?
- Adhese One F Upgrade
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to 9 Sep 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- indication for class I or II filling
- max. 2 restorations per patient
- vital teeth
- sufficient language skills
Who cannot join
- 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
About this study
Official title: 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.
- Conditions
- Dental Adhesive
- Being tested
- Adhese One F Upgrade
- Keywords
- total etch protocol, direct filling therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adhese One F UpgradeDevice
| Study group | Role | What they receive |
|---|---|---|
| Adhese One F Upgrade | Experimental | Adhese One F Upgrade (AOFU) is administered after phosphoric acid etching (etch-and-rinse protocol). Receives: Device: Adhese One F Upgrade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Clinical Success
Clinical success is defined as no postoperative hypersensitivity and no loss of the restoration.
Measured: 1 week
Secondary outcomes (1)
Clinical Quality
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).
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2014 (estimated)
- Study startJun 2012
- Primary completionJun 2015
- Study completion9 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dental AdhesiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ivoclar Vivadent AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arnd Peschke, Dr., Principal investigator, Ivoclar Vivadent AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02175368
- Sponsor's protocol ID
- AOFU 2012
- Status last verified
- Mar 2025
- First submitted
- 20 Jun 2014
- Last updated
- 1 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of AdheSE One F Upgrade in Direct Filling Therapy
- ClinicalTrials.gov ID
- NCT02175368
- Acronym / sponsor ID
- AOFU 2012
- Conditions
- Dental Adhesive
- Keywords
- total etch protocol, direct filling therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Ivoclar Vivadent AGIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- 9 Sep 2015 (actual)
- First posted
- 26 Jun 2014 (estimated)
- Results
- Posted 9 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adhese One F Upgrade | Experimental | Device: Adhese One F UpgradeAdhese One F Upgrade (AOFU) is administered after phosphoric acid etching (etch-and-rinse protocol). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- indication for class I or II filling
- max. 2 restorations per patient
- vital teeth
- sufficient language skills
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adhese One F Upgrade | Device | Adhese One F Upgrade |
Primary outcome
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 secondary outcome
Clinical Quality
Time frame: 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arnd Peschke, Dr. principal investigator
Ivoclar Vivadent AG
Questions about this trial
What is this clinical trial studying?
A study testing Adhese One F Upgrade in people with Dental Adhesive, run by Ivoclar Vivadent AG.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Clinical Success (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.