Back to resultsClinical Evaluation of 3M™ ESPE™ Adper™ Scotchbond™ SE Self-Etch Adhesive in Class I and Class II Restorations in Adults
Primary Purpose
Dental Caries
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
3M ESPE Adper Scotchbond SE
3M ESPE Adper Scotchbond 1XT
Sponsored by
About this trial
This is an interventional treatment trial for Dental Caries
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
Sites / Locations
- University of Bologna, Clinica Odontoiatrica
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Adhesive A
Adhesive B
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00658138
Brief Title
Clinical Evaluation of 3M™ ESPE™ Adper™ Scotchbond™ SE Self-Etch Adhesive in Class I and Class II Restorations in Adults
Official Title
Clinical Evaluation of 3M™ ESPE™ Adper™ Scotchbond™ SE Self-Etch Adhesive in Class I and Class II Restorations in Adults
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
3M
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Adhesive A
Arm Type
Experimental
Arm Title
Adhesive B
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
3M ESPE Adper Scotchbond SE
Other Intervention Name(s)
Dental adhesive used for bonding fillings
Intervention Description
To be used per manufacturer's instructions.
Intervention Type
Device
Intervention Name(s)
3M ESPE Adper Scotchbond 1XT
Other Intervention Name(s)
Dental adhesive used for bonding fillings
Intervention Description
To be used per manufacturer's instructions.
Primary Outcome Measure Information:
Title
Percentage of Restorations Scoring Alpha
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giovanni Dondi dall'Orologio, Professor
Organizational Affiliation
University of Bologna
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Bologna, Clinica Odontoiatrica
City
Bologna
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Clinical Evaluation of 3M™ ESPE™ Adper™ Scotchbond™ SE Self-Etch Adhesive in Class I and Class II Restorations in Adults
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