Clinical Evaluation of OBU When Used for Indirect Dental Restorations
NCT ID: NCT06002880
Last Updated: 2024-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
13 participants
INTERVENTIONAL
2023-07-14
2024-02-08
Brief Summary
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Detailed Description
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OBU contains an acidic component to etch the tooth surface in order to allow the adhesive to mechanically adhere to the prepared tooth surface. The adhesive can be used with light or without light cured prior to application of the restorative material. This allows for the adhesive to mechanically and chemically bond to the applied restorative material. OBU is formulated to provide a reliable bond strength, and it's compatible with all etching modes (self-etch, selective etch, and total etch).
Aim/Hypothesis/Objective The primary objective of this study is to evaluate the clinical performance of OBU used in the intended clinical conditions.
The device will undergo evaluation in the following categories:
Functional Properties Endodontic posts Ceramic restorations Composite and metal crowns Pretreatment for indirect restorations Core build-ups
Endpoints:
Primary endpoints:
Evaluation of clinical safety and performance of OBU, a single component universal dental adhesive intended for indirect dental restorations according to manufacturer's Instruction For Use.
(Indirect metal restoration is defined as any restoration made of precious or non-precious alloy such as inlays, onlays, porcelain fused to metal, metal full coverage crown, metal full coverage fixed partial denture). All implant restorations are excluded.
Secondary endpoints:
Post-operative sensitivity, retention, general periodontal health, and general optical properties after baseline, 6 months, 1 year and 2 years post-placement.
The hypothesis to be tested is that OBU is safe and effective in clinical settings when the device is used according to manufacturer's instructions:
H0: P ̂\_T-P ̂\_C≥ ∆ HA: P ̂\_T-P ̂\_C\< ∆ Where ∆ (delta) refers to the non-inferiority margin set at 10%.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Post/Core-Total Etch
Endodontic posts and/or cores-Total etch
Optibond Universal
OBU™ will be used used for the cementation of indirect restorations (ceramic restorations, composite, zirconia and metal crowns) and pretreatment for indirect restoration, according to manufacturer's Instruction For Use in self-etch and total-etch modes.
Ceramic-Total Etch
Glass-ceramics-Total etch
Optibond Universal
OBU™ will be used used for the cementation of indirect restorations (ceramic restorations, composite, zirconia and metal crowns) and pretreatment for indirect restoration, according to manufacturer's Instruction For Use in self-etch and total-etch modes.
Metal/Zi-Total Etch
Metal-Zi-Total etch
Optibond Universal
OBU™ will be used used for the cementation of indirect restorations (ceramic restorations, composite, zirconia and metal crowns) and pretreatment for indirect restoration, according to manufacturer's Instruction For Use in self-etch and total-etch modes.
Composite-Total Etch
Composite-Total etch
Optibond Universal
OBU™ will be used used for the cementation of indirect restorations (ceramic restorations, composite, zirconia and metal crowns) and pretreatment for indirect restoration, according to manufacturer's Instruction For Use in self-etch and total-etch modes.
Post/Core-Self Etch
Endodontic posts and/or cores-Self etch
Optibond Universal
OBU™ will be used used for the cementation of indirect restorations (ceramic restorations, composite, zirconia and metal crowns) and pretreatment for indirect restoration, according to manufacturer's Instruction For Use in self-etch and total-etch modes.
Ceramic-Self Etch
Glass-ceramics-Self etch
Optibond Universal
OBU™ will be used used for the cementation of indirect restorations (ceramic restorations, composite, zirconia and metal crowns) and pretreatment for indirect restoration, according to manufacturer's Instruction For Use in self-etch and total-etch modes.
Metal/Zi-Self Etch
Metal-Zi-Self etch
Optibond Universal
OBU™ will be used used for the cementation of indirect restorations (ceramic restorations, composite, zirconia and metal crowns) and pretreatment for indirect restoration, according to manufacturer's Instruction For Use in self-etch and total-etch modes.
Composite-Self Etch
Composite-Self etch
Optibond Universal
OBU™ will be used used for the cementation of indirect restorations (ceramic restorations, composite, zirconia and metal crowns) and pretreatment for indirect restoration, according to manufacturer's Instruction For Use in self-etch and total-etch modes.
Interventions
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Optibond Universal
OBU™ will be used used for the cementation of indirect restorations (ceramic restorations, composite, zirconia and metal crowns) and pretreatment for indirect restoration, according to manufacturer's Instruction For Use in self-etch and total-etch modes.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
100 Years
ALL
Yes
Sponsors
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Kerr Corporation
INDUSTRY
Responsible Party
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Sibel Antonson
Professor and Assistant Dean for Research and Development
Principal Investigators
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Sibel Antonson
Role: PRINCIPAL_INVESTIGATOR
NSU CDM
Locations
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Nova Southeastern University, College of dental Medicine
Fort Lauderdale, Florida, United States
Countries
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References
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Hill EE. Dental cements for definitive luting: a review and practical clinical considerations. Dent Clin North Am. 2007 Jul;51(3):643-58, vi. doi: 10.1016/j.cden.2007.04.002.
Alharbi A, Rocca GT, Dietschi D, Krejci I. Semidirect composite onlay with cavity sealing: a review of clinical procedures. J Esthet Restor Dent. 2014 Mar-Apr;26(2):97-106. doi: 10.1111/jerd.12067. Epub 2013 Dec 17.
Hickel R, Peschke A, Tyas M, Mjor I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation: clinical criteria for the evaluation of direct and indirect restorations-update and clinical examples. Clin Oral Investig. 2010 Aug;14(4):349-66. doi: 10.1007/s00784-010-0432-8. Epub 2010 Jul 14.
Other Identifiers
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Kerr 04-2022
Identifier Type: -
Identifier Source: org_study_id
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