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N/A N=61 Randomized Single-blind Treatment

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

Dental Caries

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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