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Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention.
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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 according to manufacturer's Instruction For Use.
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 strength with any etch technique, on all common substrates and in combination with any resin cement without auxiliary products (silane or metal primers) even in absence of light. OBU is intended for general population use by a dental professional.
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%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Post/Core-Total Etch | Experimental | Endodontic posts and/or cores-Total etch |
|
| Ceramic-Total Etch | Experimental | Glass-ceramics-Total etch |
|
| Metal/Zi-Total Etch | Experimental | Metal-Zi-Total etch |
|
| Composite-Total Etch | Experimental | Composite-Total etch |
|
| Post/Core-Self Etch | Experimental | Endodontic posts and/or cores-Self etch |
|
| Ceramic-Self Etch | Experimental | Glass-ceramics-Self etch |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optibond Universal | Device | OBUâ„¢ 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity Questionnaire-Visual Analog Scale 0 to 10 (0=No pain, 10=Worst pain possible) | Preoperative sensitivity | Screening |
| Sensitivity Questionnaire-Visual Analog Scale 0 to 10 (0=No pain, 10=Worst pain possible) | Preoperative sensitivity | Preparation, Provisional Restoration (up to 6 weeks from Screening) |
| Sensitivity Questionnaire-Visual Analog Scale 0 to 10 (0=No pain, 10=Worst pain possible) | Postoperative sensitivity | 48 hours after Cementation (up to 4 weeks from Preparation) |
| Sensitivity Questionnaire-Visual Analog Scale 1 to 5 (1=No pain, 5=Worst pain possible) | Postoperative sensitivity | Baseline Followup Assessments (approximately 3 weeks from Cementation) |
| Sensitivity Questionnaire-Visual Analog Scale 1 to 5 (1=No pain, 5=Worst pain possible) | Postoperative sensitivity | 6-months Followup Assessments (approximately 6 months from Baseline) |
| Sensitivity Questionnaire-Visual Analog Scale 1 to 5 (1=No pain, 5=Worst pain possible) | Postoperative sensitivity | 1-year Followup Assessments (approximately 1 year from Baseline) |
| Sensitivity Questionnaire-Visual Analog Scale 1 to 5 (1=No pain, 5=Worst pain possible) | Postoperative sensitivity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sibel Antonson | NSU CDM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nova Southeastern University, College of dental Medicine | Fort Lauderdale | Florida | 33328 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17586148 | Background | 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. | |
| 24341472 | Background | 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. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 9, 2024 | Jul 31, 2024 | 4 |
| ID | Term |
|---|---|
| D003807 | Dentin Sensitivity |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| Metal/Zi-Self Etch | Experimental | Metal-Zi-Self etch |
|
| Composite-Self Etch | Experimental | Composite-Self etch |
|
|
| 2-Year Followup Assessments (approximately 2 years from Baseline) |
| FDI (World Dental Federation) Clinical Evaluation Criteria-Modified | Functional Properties, Biological Properties, Aesthetic Properties (1 clinically excellent-5 clinically poor Scale) | Baseline Followup Assessments |
| FDI (World Dental Federation) Clinical Evaluation Criteria-Modified | Functional Properties, Biological Properties, Aesthetic Properties (1 clinically excellent-5 clinically poor Scale) | 6-months Followup Assessments |
| FDI (World Dental Federation) Clinical Evaluation Criteria-Modified | Functional Properties, Biological Properties, Aesthetic Properties (1 clinically excellent-5 clinically poor Scale) | 1-year Followup Assessments |
| FDI (World Dental Federation) Clinical Evaluation Criteria-Modified | Functional Properties, Biological Properties, Aesthetic Properties (1 clinically excellent-5 clinically poor Scale) | 2-Year Followup Assessments |
| 20628774 | Background | 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. |