Dental Adhesive
Conditions
Keywords
total etch protocol, direct filling therapy
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.
Interventions
DEVICEAdhese One F Upgrade
Sponsors
Ivoclar Vivadent AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinical Success | 1 week | Clinical success is defined as no postoperative hypersensitivity and no loss of the restoration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Quality | 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). |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Adhese One F Upgrade Adhese One F Upgrade (AOFU) is administered after phosphoric acid etching (etch-and-rinse protocol).
Adhese One F Upgrade | 28 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Adhese One F Upgrade | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 28 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Liechtenstein | 28 Participants | — |
| Sex: Female, Male Female | 14 Participants | — |
| Sex: Female, Male Male | 14 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 28 |
| other Total, other adverse events | 0 / 28 |
| serious Total, serious adverse events | 0 / 28 |
Outcome results
Primary
Number of Participants With Clinical Success
Clinical success is defined as no postoperative hypersensitivity and no loss of the restoration.
Time frame: 1 week
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Adhese One F Upgrade | Number of Participants With Clinical Success | 28 Participants |
Secondary
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).
Time frame: 3 years
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Adhese One F Upgrade | Clinical Quality | Patients with satisfactory clinical outcome | 28 Participants |
| Adhese One F Upgrade | Clinical Quality | Patients with unsatisfactory clinical outcome | 0 Participants |