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OpenTrials
Completed

NCT Number: NCT00658138

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

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.

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Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Bologna, Clinica Odontoiatrica

Bologna, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3M ESPE Adper Scotchbond SE

Device

To be used per manufacturer's instructions.

Other names: Dental adhesive used for bonding fillings

3M ESPE Adper Scotchbond 1XT

Device

To be used per manufacturer's instructions.

Other names: Dental adhesive used for bonding fillings

Primary outcomes

  1. Percentage of Restorations Scoring Alpha

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Solventum US LLC

Industry

Collaborators

  • 3M

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Apr 14, 2008
Registry last updated
Oct 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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