← Back to Search

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

Select...

My tooth can be fixed and has healthy structure above the gum.

Select...

My study tooth has an opposing tooth and at least one neighboring tooth.

Select...

My study teeth are healthy or properly treated and symptom-free.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2-year followup assessments (approximately 2 years from baseline)

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Kerr CorporationLead Sponsor

1 Previous Clinical Trials

24 Total Patients Enrolled

Sibel AntonsonPrincipal InvestigatorNSU CDM

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this investigation accept participants aged 18 and above?

"Prospective participants should take note that the age requirement for this medical trial ranges from 18 to 100 years old."

Answered by AI

What qualifications are needed to be included in this trial?

"To take part in this medical study, applicants must have a history of tooth sensitivity and fall within the age range between 18 and 100. At present, around 160 viable candidates are being sought for participation."

Answered by AI

Has the enrollment period for this experiment expired?

"This clinical investigation is actively recruiting suitable subjects, as detailed on clinicaltrials.gov. The trial was first announced on 14th July 2023 and has been recently updated 18th August of the same year."

Answered by AI

How many participants are enrolled in the current clinical experiment?

"Affirmative. According to information published on clinicaltrials.gov, this research project is presently recruiting participants and was first posted on July 14th 2023 with a most recent update occurring August 18th 2023. The ongoing study requires 160 individuals at 1 medical centre for enrollment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Clinical Evaluation of OBU When Used for Indirect Dental Restorations

Sibel Antonson 2023. "Clinical Evaluation of OBU When Used for Indirect Dental Restorations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06002880.