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
- 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
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
- 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Bologna, Clinica Odontoiatrica
🇮🇹Bologna, Italy
University of Bologna, Clinica Odontoiatrica🇮🇹Bologna, Italy