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OpenTrials
Completed

NCT Number: NCT00643461

Clinical Evaluation of Three Dental Adhesive Systems in Class V Restorations

The purpose of this study is to compare the clinical performance of three dental adhesive systems used to bond Class V cavity fillings in adult teeth.

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Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alabama at Birmingham (UAB) School of Dentistry

Birmingham, Alabama, 35294, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Must be at least 19 years of age
  • Must have at least 3 qualifying noncarious Class V lesions of appropriate depth
  • Must be willing to sign consent form
  • Must be willing and able to return to UAB 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
  • Severe salivary gland dysfunction
  • Rampant caries (cavities)
  • Chronic periodontitis (gum disease)
  • Known allergies to the study materials
  • Unacceptable level of oral hygiene
  • Inability or unwillingness to attend study appointments

Treatment and study plan

Adhesive A

Device

Applied per manufacturer's instructions.

Other names: Adper Scotchbond SE (3M ESPE)

Adhesive B

Device

Applied per manufacturer's instructions.

Other names: Adper Easy Bond (3M ESPE)

Adhesive C

Device

Applied per manufacturer's instructions.

Other names: Single Bond Plus (3M ESPE)

Primary outcomes

  1. Retention of the restoration.

    Time frame: 6, 12, 24, 36 months post-placement

Sponsors and collaborators

Lead sponsor

Solventum US LLC

Industry

Collaborators

  • 3M

Registry information

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Mar 26, 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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