N/A
N=61
Clinical Evaluation of 3M™ ESPE™ Adper™ Scotchbond™ SE Self-Etch Adhesive in Class I and Class II Restorations in Adults
Dental Caries
Bottom Line
View on ClinicalTrials.gov: NCT00658138 ↗Enrolled (actual)
61
Serious AEs
0.0%
Results posted
Mar 2012
Primary outcome: Primary: Percentage of Restorations Scoring Alpha — 100; 96 percentage of Alpha scores — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 3M ESPE Adper Scotchbond SE (Device); 3M ESPE Adper Scotchbond 1XT (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Solventum US LLC
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Restorations Scoring Alpha |
100; 96 | 0.05 |
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.
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
Data sourced from ClinicalTrials.gov (NCT00658138). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.