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

Not Applicable

Completed

• Conditions: Dental Caries
• Interventions: Device: 3M ESPE Adper Scotchbond SE; Device: 3M ESPE Adper Scotchbond 1XT

• Registration Number: NCT00658138
• Lead Sponsor: Solventum US LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-04-08
• Study First Submitted QC: 2008-04-08
• Study First Posted: 2008-04-14
• Study Start: 2008-12
• Primary Completion: 2010-11
• Study Completion: 2011-12
• Results First Submitted: 2011-12-29
• Results First Submitted QC: 2012-02-23
• Results First Posted: 2012-03-26
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adhesive A	3M ESPE Adper Scotchbond SE	-
Adhesive B	3M ESPE Adper Scotchbond 1XT	-

Primary Outcome Measures

Name	Time	Method
Percentage of Restorations Scoring Alpha	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.

Trial Locations

Locations (1)

University of Bologna, Clinica Odontoiatrica; 🇮🇹 Bologna, Italy