Sensitivity, ToothNCT06002880
Clinical Evaluation of OBU When Used for Indirect Dental Restorations
A study testing Optibond Universal in people with Sensitivity, Tooth, run by Kerr Corporation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Sensitivity, Tooth
- What is being tested?
- Optibond Universal
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2023to 8 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nova Southeastern University, College of dental Medicine
Fort Lauderdale, Florida, 33328
About this study
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.
Read the 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%.
- Conditions
- Sensitivity, Tooth
- Being tested
- Optibond Universal
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optibond UniversalDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Post/Core-Total Etch | Experimental | Endodontic posts and/or cores-Total etch Receives: Device: Optibond Universal |
| Ceramic-Total Etch | Experimental | Glass-ceramics-Total etch Receives: Device: Optibond Universal |
| Metal/Zi-Total Etch | Experimental | Metal-Zi-Total etch Receives: Device: Optibond Universal |
| Composite-Total Etch | Experimental | Composite-Total etch Receives: Device: Optibond Universal |
| Post/Core-Self Etch | Experimental | Endodontic posts and/or cores-Self etch Receives: Device: Optibond Universal |
| Ceramic-Self Etch | Experimental | Glass-ceramics-Self etch Receives: Device: Optibond Universal |
| Metal/Zi-Self Etch | Experimental | Metal-Zi-Self etch Receives: Device: Optibond Universal |
| Composite-Self Etch | Experimental | Composite-Self etch Receives: Device: Optibond Universal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity Questionnaire-Visual Analog Scale 0 to 10 (0=No pain, 10=Worst pain possible)
Preoperative sensitivity
Measured: Screening
Sensitivity Questionnaire-Visual Analog Scale 0 to 10 (0=No pain, 10=Worst pain possible)
Preoperative sensitivity
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: Baseline Followup Assessments
FDI (World Dental Federation) Clinical Evaluation Criteria-Modified
Functional Properties, Biological Properties, Aesthetic Properties (1 clinically excellent-5 clinically poor Scale)
Measured: 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)
Measured: 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)
Measured: 2-Year Followup Assessments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start14 Jul 2023
- Primary completion8 Feb 2024
- Study completion8 Feb 2024
Why it stopped: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sensitivity, ToothStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kerr Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Sibel Antonson, Nova Southeastern University
- Investigators
- Sibel Antonson, Principal investigator, NSU CDM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06002880
- Sponsor's protocol ID
- Kerr 04-2022
- Status last verified
- Feb 2024
- First submitted
- 24 Jul 2023
- Last updated
- 12 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 17586148Alharbi 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.
PubMed 24341472Hickel 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.
PubMed 20628774
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of OBU When Used for Indirect Dental Restorations
- ClinicalTrials.gov ID
- NCT06002880
- Acronym / sponsor ID
- Kerr 04-2022
- Conditions
- Sensitivity, Tooth
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Kerr CorporationIndustry (pharma, biotech, devices)
- Study start
- 14 Jul 2023 (actual)
- Primary completion
- 8 Feb 2024 (actual)
- Study completion
- 8 Feb 2024 (actual)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Post/Core-Total Etch | Experimental | Device: Optibond UniversalEndodontic posts and/or cores-Total etch |
| Ceramic-Total Etch | Experimental | Device: Optibond UniversalGlass-ceramics-Total etch |
| Metal/Zi-Total Etch | Experimental | Device: Optibond UniversalMetal-Zi-Total etch |
| Composite-Total Etch | Experimental | Device: Optibond UniversalComposite-Total etch |
| Post/Core-Self Etch | Experimental | Device: Optibond UniversalEndodontic posts and/or cores-Self etch |
| Ceramic-Self Etch | Experimental | Device: Optibond UniversalGlass-ceramics-Self etch |
| Metal/Zi-Self Etch | Experimental | Device: Optibond UniversalMetal-Zi-Self etch |
| Composite-Self Etch | Experimental | Device: Optibond UniversalComposite-Self etch |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optibond UniversalOBU™ 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. | Device | Ceramic-Self Etch, Ceramic-Total Etch, Composite-Self Etch, Composite-Total Etch, Metal/Zi-Self Etch, Metal/Zi-Total Etch, Post/Core-Self Etch, Post/Core-Total Etch |
Primary outcome
Sensitivity Questionnaire-Visual Analog Scale 0 to 10 (0=No pain, 10=Worst pain possible)
Time frame: Screening
Preoperative sensitivity
Sensitivity Questionnaire-Visual Analog Scale 0 to 10 (0=No pain, 10=Worst pain possible)
Time frame: Preparation, Provisional Restoration (up to 6 weeks from Screening)
Preoperative sensitivity
Sensitivity Questionnaire-Visual Analog Scale 0 to 10 (0=No pain, 10=Worst pain possible)
Time frame: 48 hours after Cementation (up to 4 weeks from Preparation)
Postoperative sensitivity
Sensitivity Questionnaire-Visual Analog Scale 1 to 5 (1=No pain, 5=Worst pain possible)
Time frame: Baseline Followup Assessments (approximately 3 weeks from Cementation)
Postoperative sensitivity
Sensitivity Questionnaire-Visual Analog Scale 1 to 5 (1=No pain, 5=Worst pain possible)
Time frame: 6-months Followup Assessments (approximately 6 months from Baseline)
Postoperative sensitivity
Sensitivity Questionnaire-Visual Analog Scale 1 to 5 (1=No pain, 5=Worst pain possible)
Time frame: 1-year Followup Assessments (approximately 1 year from Baseline)
Postoperative sensitivity
Sensitivity Questionnaire-Visual Analog Scale 1 to 5 (1=No pain, 5=Worst pain possible)
Time frame: 2-Year Followup Assessments (approximately 2 years from Baseline)
Postoperative sensitivity
FDI (World Dental Federation) Clinical Evaluation Criteria-Modified
Time frame: Baseline Followup Assessments
Functional Properties, Biological Properties, Aesthetic Properties (1 clinically excellent-5 clinically poor Scale)
FDI (World Dental Federation) Clinical Evaluation Criteria-Modified
Time frame: 6-months Followup Assessments
Functional Properties, Biological Properties, Aesthetic Properties (1 clinically excellent-5 clinically poor Scale)
FDI (World Dental Federation) Clinical Evaluation Criteria-Modified
Time frame: 1-year Followup Assessments
Functional Properties, Biological Properties, Aesthetic Properties (1 clinically excellent-5 clinically poor Scale)
FDI (World Dental Federation) Clinical Evaluation Criteria-Modified
Time frame: 2-Year Followup Assessments
Functional Properties, Biological Properties, Aesthetic Properties (1 clinically excellent-5 clinically poor Scale)
Results and safety
The study was stopped early (reason given: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
- Background: PubMed 17586148Hill 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.
- Background: PubMed 24341472Alharbi 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.
- Background: PubMed 20628774Hickel 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sibel Antonson principal investigator
NSU CDM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optibond Universal in people with Sensitivity, Tooth, run by Kerr Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity Questionnaire-Visual Analog Scale 0 to 10 (0=No pain, 10=Worst pain possible) (time frame: Screening). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06002880, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2024.