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CompletedNCT00643461Updated Oct 2, 2024

Clinical Evaluation of Three Dental Adhesive Systems in Class V Restorations

An observational study in Dental Caries, sponsored by Solventum US LLC. Completed at 1 site in United States. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2024-10-02.

Sponsored by Solventum US LLC · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
46
Ages
19 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Dental Caries

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03

In context

Dental Caries

1,109 studies on the registry are indexed under Dental Caries; 197 are open to participants now.

This study's enrollment of 46 is below the median of 180 across 177 observational studies indexed under Dental Caries.

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Lead sponsor

Solventum US LLC is the lead sponsor of 62 studies on the registry; 2 are open to participants now.

Of its 18 completed or terminated interventional studies of FDA-regulated products, 16 (89%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Class V cavities

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
46 participants (actual)
Patient registry
No

Groups and cohorts

  • Adhesive A

    Device: Adhesive A

  • Adhesive B

    Device: Adhesive B

  • Adhesive C

    Device: Adhesive C

Interventions

  • DeviceAdhesive A

    Applied per manufacturer's instructions.

    Also known as: Adper Scotchbond SE (3M ESPE)

  • DeviceAdhesive B

    Applied per manufacturer's instructions.

    Also known as: Adper Easy Bond (3M ESPE)

  • DeviceAdhesive C

    Applied per manufacturer's instructions.

    Also known as: Single Bond Plus (3M ESPE)

06

What researchers measure

Primary outcomes

  1. Retention of the restoration.

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

07

Study locations

1 site
  • University of Alabama at Birmingham (UAB) School of Dentistry
    Birmingham, Alabama 35294, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00643461
Lead sponsor
Solventum US LLC
Collaborators
3M
Responsible party
Sponsor
First posted
Mar 26, 2008
Start date
Apr 2008
Primary completion
Feb 2012
Completion
Jun 2012
Last update
Oct 2, 2024

Study contacts

John O Burgess, MS, DDS
principal investigator · University of Alabama at Birmingham (UAB) School of Dentistry

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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