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

September 30, 2024 updated by: Solventum US LLC
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy
        • University of Bologna, Clinica Odontoiatrica

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adhesive A
Device: 3M ESPE Adper Scotchbond SE
To be used per manufacturer's instructions.
Other Names:
  • Dental adhesive used for bonding fillings
Active Comparator: Adhesive B
Device: 3M ESPE Adper Scotchbond 1XT
To be used per manufacturer's instructions.
Other Names:
  • Dental adhesive used for bonding fillings

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Solventum US LLC

Collaborators

3M

Investigators

  • Principal Investigator: Giovanni Dondi dall'Orologio, Professor, University of Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

April 8, 2008

First Submitted That Met QC Criteria

April 8, 2008

First Posted (Estimated)

April 14, 2008

Study Record Updates

Last Update Posted (Actual)

October 2, 2024

Last Update Submitted That Met QC Criteria

September 30, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR-07-020

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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