Adhese One F Upgrade in Direct Filling Therapy

Not Applicable

Completed

• Conditions: Dental Adhesive
• Interventions: Device: Adhese One F Upgrade

• Registration Number: NCT02175368
• Lead Sponsor: Ivoclar Vivadent AG

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2014-06-20
• Study First Submitted QC: 2014-06-25
• Study First Posted: 2014-06-26
• Primary Completion: 2015-06
• Study Completion: 2015-09-09
• Results First Submitted: 2018-03-12
• Results First Submitted QC: 2018-03-12
• Results First Posted: 2018-04-09
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of Participants With Clinical Success	1 week	Clinical success is defined as no postoperative hypersensitivity and no loss of the restoration.

Secondary Outcome Measures

Name	Time	Method
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).