Clinical Evaluation of 3M™ ESPE™ Adper™ Scotchbond™ SE Self-Etch Adhesive in Class I and Class II Restorations in Adults

Solventum US LLC1 site in 1 country61 target enrollmentDecember 2008

ConditionsDental Caries

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Dental Caries
Sponsor: Solventum US LLC
Enrollment: 61
Locations: 1
Primary Endpoint: Percentage of Restorations Scoring Alpha
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the performance of a new dental adhesive system in the restoration of Class I and Class II cavities in adult teeth.

Registry

clinicaltrials.gov

Start Date

December 2008

End Date

December 2011

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Solventum US LLC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Must be at least 18 years of age
•Must have 2 or 4 qualifying Class I or Class II cavities
•Must be willing to sign consent form
•Must be willing to return to University dental clinic for 4 study appointments
•Must be in good medical health and able to tolerate dental procedures

Exclusion Criteria

•Current participation in other restorative product studies
•Known allergies to dental products
•Unacceptable level of oral hygiene
•Chronic periodontitis (gum disease)
•Rampant caries (cavities)
•Severe salivary gland problems
•Inability or unwillingness to attend study appointments

Outcomes

Primary Outcomes

Percentage of Restorations Scoring Alpha

Time Frame: 12 months

Restorations were scored Alpha, Bravo or Charlie for retention, post-operative sensitivity, anatomic form, margin integrity, color match, stain resistance, and secondary caries. Alpha score = 'excellent' Bravo = 'acceptable' Charlie = 'unsatisfactory'. Total Alpha scores were evaluated for the primary outcome.