Trial Outcomes & Findings for Adhese One F Upgrade in Direct Filling Therapy (NCT NCT02175368)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

28 participants

Primary outcome timeframe

1 week

Results posted on

2025-04-01

Participant Flow

Participant milestones

Participant milestones
Measure	Adhese One F Upgrade Adhese One F Upgrade (AOFU) is administered after phosphoric acid etching (etch-and-rinse protocol). Adhese One F Upgrade
Overall Study STARTED	28
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Adhese One F Upgrade Adhese One F Upgrade (AOFU) is administered after phosphoric acid etching (etch-and-rinse protocol). Adhese One F Upgrade
Overall Study Lost to Follow-up	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Adhese One F Upgrade n=28 Participants Adhese One F Upgrade (AOFU) is administered after phosphoric acid etching (etch-and-rinse protocol). Adhese One F Upgrade
Age, Categorical <=18 years	0 Participants n=28 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=28 Participants
Age, Categorical >=65 years	0 Participants n=28 Participants
Sex: Female, Male Female	14 Participants n=28 Participants
Sex: Female, Male Male	14 Participants n=28 Participants
Region of Enrollment Liechtenstein	28 Participants n=28 Participants

PRIMARY outcome

Timeframe: 1 week

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

Outcome measures

Outcome measures
Measure	Adhese One F Upgrade n=28 Participants Adhese One F Upgrade (AOFU) is administered after phosphoric acid etching (etch-and-rinse protocol). Adhese One F Upgrade
Number of Participants With Clinical Success	28 Participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Adhese One F Upgrade n=28 Participants Adhese One F Upgrade (AOFU) is administered after phosphoric acid etching (etch-and-rinse protocol). Adhese One F Upgrade
Clinical Quality Patients with satisfactory clinical outcome	28 Participants
Clinical Quality Patients with unsatisfactory clinical outcome	0 Participants

Adverse Events

Adhese One F Upgrade

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Erik Braziulis

Ivoclar Vivadent AG

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place