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Dental Adhesive

Dental Adhesive for Indirect Restorations

N/A
Waitlist Available
Led By Sibel Antonson
Research Sponsored by Kerr Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2-year followup assessments (approximately 2 years from baseline)
Awards & highlights

Study Summary

This trial evaluates the safety of a dental adhesive for indirect restorations, to ensure it's safe and works according to instructions.

Who is the study for?
This trial is for individuals with one qualifying molar or premolar needing a dental restoration. Eligible teeth must be restorable, vital or properly treated, and not have periapical pathology. Participants need good health, no severe oral conditions, and can't be pregnant or breastfeeding. They must consent to the study in English.Check my eligibility
What is being tested?
The trial tests Optibond Universal (OBU), an adhesive for indirect dental restorations. It assesses OBU's safety and performance when used according to the manufacturer's instructions on eligible patients' teeth.See study design
What are the potential side effects?
While specific side effects are not listed, potential risks may include tooth sensitivity, allergic reactions to materials like methacrylates used in OBU or discomfort from dental procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My tooth can be fixed and has healthy structure above the gum.
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My study tooth has an opposing tooth and at least one neighboring tooth.
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My study teeth are healthy or properly treated and symptom-free.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2-year followup assessments (approximately 2 years from baseline)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2-year followup assessments (approximately 2 years from baseline) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
FDI (World Dental Federation) Clinical Evaluation Criteria-Modified
Sensitivity Questionnaire-Visual Analog Scale 0 to 10 (0=No pain, 10=Worst pain possible)
Sensitivity Questionnaire-Visual Analog Scale 1 to 5 (1=No pain, 5=Worst pain possible)

Trial Design

8Treatment groups
Experimental Treatment
Group I: Post/Core-Total EtchExperimental Treatment1 Intervention
Endodontic posts and/or cores-Total etch
Group II: Post/Core-Self EtchExperimental Treatment1 Intervention
Endodontic posts and/or cores-Self etch
Group III: Metal/Zi-Total EtchExperimental Treatment1 Intervention
Metal-Zi-Total etch
Group IV: Metal/Zi-Self EtchExperimental Treatment1 Intervention
Metal-Zi-Self etch
Group V: Composite-Total EtchExperimental Treatment1 Intervention
Composite-Total etch
Group VI: Composite-Self EtchExperimental Treatment1 Intervention
Composite-Self etch
Group VII: Ceramic-Total EtchExperimental Treatment1 Intervention
Glass-ceramics-Total etch
Group VIII: Ceramic-Self EtchExperimental Treatment1 Intervention
Glass-ceramics-Self etch

Find a Location

Who is running the clinical trial?

Kerr CorporationLead Sponsor
1 Previous Clinical Trials
24 Total Patients Enrolled
Sibel AntonsonPrincipal InvestigatorNSU CDM
~7 spots leftby May 2025
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