Status:
TERMINATED
Clinical Evaluation of OBU When Used for Indirect Dental Restorations
Lead Sponsor:
Kerr Corporation
Conditions:
Sensitivity, Tooth
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
The objective of this study is to evaluate the clinical safety and performance of Optibond Universal (OBU), a single component universal dental adhesive intended for indirect dental restorations accor...
Detailed Description
The device used in the study, Optibond Universal (OBU) is a single component universal dental adhesive intended for direct and indirect dental restorations. OBU is formulated to provide reliable bond ...
Eligibility Criteria
Inclusion
- Is willing to provide voluntary written informed consent in English.
- Is in good medical health and able to tolerate the dental procedures.
- Has 1 qualifying either vital or endodontically treated molar and/or premolar that requires an endodontic post and or core build-ups with subsequent indirect restoration or an indirect restoration only. Only 1 tooth per quadrant can be included in the study if more than 1 tooth in need of restoration. The maximum number of restorations will not exceed two per patient.
- The tooth must be restorable, i.e. without subgingival caries and must have a minimum of 2-3 mm healthy supragingival tooth structure.
- Study teeth must have an antagonist in the opposite jaw and have a neighboring tooth on at least one side.
- Study teeth must be vital and without any symptoms suggesting irreversible damage of the pulp, or endodontically treated and hermetically filled according to standards of care (i.e., free of clinical signs and symptoms of periapical pathology).
Exclusion
- Is currently taking part in an evaluation of other dental procedures.
- Has chronic periodontitis or rampant caries.
- The study tooth exhibits clinical signs of periapical pathology.
- The study tooth has a history of self-reported preoperative pulpal problems.
- The study tooth that has been restored using eugenol containing materials.
- Study Subjects with severe parafunctional habits or occlusal issues affecting the subject teeth.
- Women who are pregnant (self-reported). It is standard of care to postpone routine dental procedures and radiographed until after pregnancy.
- Women who are breast feeding.
- Known allergy to methacrylates or other components of resin composites, local anesthetics, or metals used for dental restorations.
- An employee of the sponsor or members of their immediate family.
- Condition affecting salivary flow (e.g., salivary gland disorder, Sjögren's Syndrome, xerogenic medications).
- Are unwilling or unable to have dental radiographs or photographs taken of their dentition and soft tissues.
- Unable to return to the recall visits.
- Any other condition which is the view of the investigator may affect the ability of a patient to complete the study.
- Teeth with implant restorations.
- Third molars.
Key Trial Info
Start Date :
July 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 8 2024
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT06002880
Start Date
July 14 2023
End Date
February 8 2024
Last Update
February 12 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Nova Southeastern University, College of dental Medicine
Fort Lauderdale, Florida, United States, 33328