NCT02175368

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2012

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

June 20, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 26, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 9, 2015

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

April 9, 2018

Completed
Last Updated

April 1, 2025

Status Verified

March 1, 2025

Enrollment Period

3 years

First QC Date

June 20, 2014

Results QC Date

March 12, 2018

Last Update Submit

March 13, 2025

Conditions

Dental Adhesive

Keywords

total etch protocoldirect filling therapy

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Clinical Success

    Clinical success is defined as no postoperative hypersensitivity and no loss of the restoration.

    1 week

Secondary Outcomes (1)

  • Clinical Quality

    3 years

Study Arms (1)

Adhese One F Upgrade

EXPERIMENTAL

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

Device: Adhese One F Upgrade

Interventions

Adhese One F UpgradeDEVICE
Adhese One F Upgrade

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Results Point of Contact

Title
Dr. Erik Braziulis
Organization
Ivoclar Vivadent AG
erik.braziulis@ivoclarvivadent.com

Study Officials

  • Arnd Peschke, Dr.

    Ivoclar Vivadent AG

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2014

First Posted

June 26, 2014

Study Start

June 1, 2012

Primary Completion

June 1, 2015

Study Completion

September 9, 2015

Last Updated

April 1, 2025

Results First Posted

April 9, 2018

Record last verified: 2025-03