Adhese One F Upgrade in Direct Filling Therapy
|ClinicalTrials.gov Identifier: NCT02175368|
Recruitment Status : Completed
First Posted : June 26, 2014
Results First Posted : April 9, 2018
Last Update Posted : April 9, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Dental Adhesive||Device: Adhese One F Upgrade||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Evaluation of AdheSE One F Upgrade in Direct Filling Therapy|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||September 9, 2015|
Experimental: Adhese One F Upgrade
Adhese One F Upgrade (AOFU) is administered after phosphoric acid etching (etch-and-rinse protocol).
Device: Adhese One F Upgrade
- Number of Participants With Clinical Success [ Time Frame: 1 week ]Clinical success is defined as no postoperative hypersensitivity and no loss of the restoration.
- Clinical Quality [ Time Frame: 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 or not acceptable.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02175368
|Principal Investigator:||Arnd Peschke, Dr.||Ivoclar Vivadent AG|