Back to resultsClinical Evaluation of OBU When Used for Indirect Dental Restorations
Primary Purpose
Sensitivity, Tooth
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Optibond Universal
Sponsored by
About this trial
This is an interventional treatment trial for Sensitivity, Tooth
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Sites / Locations
- Nova Southeastern University, College of dental MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Post/Core-Total Etch
Ceramic-Total Etch
Metal/Zi-Total Etch
Composite-Total Etch
Post/Core-Self Etch
Ceramic-Self Etch
Metal/Zi-Self Etch
Composite-Self Etch
Arm Description
Endodontic posts and/or cores-Total etch
Glass-ceramics-Total etch
Metal-Zi-Total etch
Composite-Total etch
Endodontic posts and/or cores-Self etch
Glass-ceramics-Self etch
Metal-Zi-Self etch
Composite-Self etch
Outcomes
Primary Outcome Measures
Sensitivity Questionnaire-Visual Analog Scale 0 to 10 (0=No pain, 10=Worst pain possible)
Preoperative sensitivity
Sensitivity Questionnaire-Visual Analog Scale 0 to 10 (0=No pain, 10=Worst pain possible)
Preoperative sensitivity
Sensitivity Questionnaire-Visual Analog Scale 0 to 10 (0=No pain, 10=Worst pain possible)
Postoperative sensitivity
Sensitivity Questionnaire-Visual Analog Scale 1 to 5 (1=No pain, 5=Worst pain possible)
Postoperative sensitivity
Sensitivity Questionnaire-Visual Analog Scale 1 to 5 (1=No pain, 5=Worst pain possible)
Postoperative sensitivity
Sensitivity Questionnaire-Visual Analog Scale 1 to 5 (1=No pain, 5=Worst pain possible)
Postoperative sensitivity
Sensitivity Questionnaire-Visual Analog Scale 1 to 5 (1=No pain, 5=Worst pain possible)
Postoperative sensitivity
FDI (World Dental Federation) Clinical Evaluation Criteria-Modified
Functional Properties, Biological Properties, Aesthetic Properties (1 clinically excellent-5 clinically poor Scale)
FDI (World Dental Federation) Clinical Evaluation Criteria-Modified
Functional Properties, Biological Properties, Aesthetic Properties (1 clinically excellent-5 clinically poor Scale)
FDI (World Dental Federation) Clinical Evaluation Criteria-Modified
Functional Properties, Biological Properties, Aesthetic Properties (1 clinically excellent-5 clinically poor Scale)
FDI (World Dental Federation) Clinical Evaluation Criteria-Modified
Functional Properties, Biological Properties, Aesthetic Properties (1 clinically excellent-5 clinically poor Scale)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06002880
Brief Title
Clinical Evaluation of OBU When Used for Indirect Dental Restorations
Official Title
Clinical Evaluation of OBU When Used for Indirect Dental Restorations
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 14, 2023 (Actual)
Primary Completion Date
November 30, 2025 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kerr Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
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 according to manufacturer's Instruction For Use.
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 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%.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sensitivity, Tooth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Post/Core-Total Etch
Arm Type
Experimental
Arm Description
Endodontic posts and/or cores-Total etch
Arm Title
Ceramic-Total Etch
Arm Type
Experimental
Arm Description
Glass-ceramics-Total etch
Arm Title
Metal/Zi-Total Etch
Arm Type
Experimental
Arm Description
Metal-Zi-Total etch
Arm Title
Composite-Total Etch
Arm Type
Experimental
Arm Description
Composite-Total etch
Arm Title
Post/Core-Self Etch
Arm Type
Experimental
Arm Description
Endodontic posts and/or cores-Self etch
Arm Title
Ceramic-Self Etch
Arm Type
Experimental
Arm Description
Glass-ceramics-Self etch
Arm Title
Metal/Zi-Self Etch
Arm Type
Experimental
Arm Description
Metal-Zi-Self etch
Arm Title
Composite-Self Etch
Arm Type
Experimental
Arm Description
Composite-Self etch
Intervention Type
Device
Intervention Name(s)
Optibond Universal
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sensitivity Questionnaire-Visual Analog Scale 0 to 10 (0=No pain, 10=Worst pain possible)
Description
Preoperative sensitivity
Time Frame
Screening
Title
Sensitivity Questionnaire-Visual Analog Scale 0 to 10 (0=No pain, 10=Worst pain possible)
Description
Preoperative sensitivity
Time Frame
Preparation, Provisional Restoration (up to 6 weeks from Screening)
Title
Sensitivity Questionnaire-Visual Analog Scale 0 to 10 (0=No pain, 10=Worst pain possible)
Description
Postoperative sensitivity
Time Frame
48 hours after Cementation (up to 4 weeks from Preparation)
Title
Sensitivity Questionnaire-Visual Analog Scale 1 to 5 (1=No pain, 5=Worst pain possible)
Description
Postoperative sensitivity
Time Frame
Baseline Followup Assessments (approximately 3 weeks from Cementation)
Title
Sensitivity Questionnaire-Visual Analog Scale 1 to 5 (1=No pain, 5=Worst pain possible)
Description
Postoperative sensitivity
Time Frame
6-months Followup Assessments (approximately 6 months from Baseline)
Title
Sensitivity Questionnaire-Visual Analog Scale 1 to 5 (1=No pain, 5=Worst pain possible)
Description
Postoperative sensitivity
Time Frame
1-year Followup Assessments (approximately 1 year from Baseline)
Title
Sensitivity Questionnaire-Visual Analog Scale 1 to 5 (1=No pain, 5=Worst pain possible)
Description
Postoperative sensitivity
Time Frame
2-Year Followup Assessments (approximately 2 years from Baseline)
Title
FDI (World Dental Federation) Clinical Evaluation Criteria-Modified
Description
Functional Properties, Biological Properties, Aesthetic Properties (1 clinically excellent-5 clinically poor Scale)
Time Frame
Baseline Followup Assessments
Title
FDI (World Dental Federation) Clinical Evaluation Criteria-Modified
Description
Functional Properties, Biological Properties, Aesthetic Properties (1 clinically excellent-5 clinically poor Scale)
Time Frame
6-months Followup Assessments
Title
FDI (World Dental Federation) Clinical Evaluation Criteria-Modified
Description
Functional Properties, Biological Properties, Aesthetic Properties (1 clinically excellent-5 clinically poor Scale)
Time Frame
1-year Followup Assessments
Title
FDI (World Dental Federation) Clinical Evaluation Criteria-Modified
Description
Functional Properties, Biological Properties, Aesthetic Properties (1 clinically excellent-5 clinically poor Scale)
Time Frame
2-Year Followup Assessments
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sibel Antonson
Phone
9542627604
Email
sibel.antonson@nova.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ria Achong-Bowe
Phone
(954) 262-7393
Email
rachongb@nova.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sibel Antonson
Organizational Affiliation
NSU CDM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nova Southeastern University, College of dental Medicine
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33328
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sibel Antonson
Phone
954-262-7604
Email
sibel.antonson@nova.edu
First Name & Middle Initial & Last Name & Degree
Ria Achong-Bowe
Phone
(954) 262-7393
Email
rachongb@nova.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
17586148
Citation
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.
Results Reference
background
PubMed Identifier
24341472
Citation
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.
Results Reference
background
PubMed Identifier
20628774
Citation
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.
Results Reference
background
Learn more about this trial
Clinical Evaluation of OBU When Used for Indirect Dental Restorations
We'll reach out to this number within 24 hrs