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

Dental Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00658138
• Other study ID #: CR-07-020
• Status: Completed
• Phase: N/A
• First received: April 8, 2008
• Last updated: February 23, 2012
• Start date: December 2008
• Est. completion date: December 2011

Study information

• Verified date: February 2012
• Source: 3M
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: December 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Caries

Intervention

Device:
• 3M ESPE Adper Scotchbond SE
To be used per manufacturer's instructions.
• 3M ESPE Adper Scotchbond 1XT
To be used per manufacturer's instructions.

Locations

Country	Name	City	State
Italy	University of Bologna, Clinica Odontoiatrica	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
3M

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months	No