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

Solventum US LLC

Status: Completed

Conditions: Dental Caries

Treatments: Device: 3M ESPE Adper Scotchbond SE; Device: 3M ESPE Adper Scotchbond 1XT

Study type: Interventional

Funder types: Industry

Identifiers

NCT00658138

CR-07-020

Details and patient eligibility

About

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.

Enrollment: 61 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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61 participants in 2 patient groups

Adhesive A

Experimental group

Treatment:

Device: 3M ESPE Adper Scotchbond SE

Adhesive B

Active Comparator group

Treatment:

Device: 3M ESPE Adper Scotchbond 1XT