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

Solventum US LLC61 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Dental Caries

Interventions

3M ESPE Adper Scotchbond SEDEVICE

To be used per manufacturer's instructions.

3M ESPE Adper Scotchbond 1XTDEVICE

To be used per manufacturer's instructions.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Bologna, Clinica Odontoiatrica

Bologna, Italy

Outcomes

Primary Outcomes

Percentage of Restorations Scoring Alpha

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.

Time frame: 12 months

Data from ClinicalTrials.gov

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