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

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ClinicalTrials.gov Identifier: NCT00658138
Recruitment Status : Completed
First Posted : April 14, 2008
Results First Posted : March 26, 2012
Last Update Posted : March 26, 2012
Sponsor:
Information provided by (Responsible Party):
3M

Brief 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.

Condition or disease Intervention/treatment Phase
Dental Caries Device: 3M ESPE Adper Scotchbond SE Device: 3M ESPE Adper Scotchbond 1XT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of 3M™ ESPE™ Adper™ Scotchbond™ SE Self-Etch Adhesive in Class I and Class II Restorations in Adults
Study Start Date : December 2008
Actual Primary Completion Date : November 2010
Actual Study Completion Date : December 2011

Arm Intervention/treatment
Experimental: Adhesive A Device: 3M ESPE Adper Scotchbond SE
To be used per manufacturer's instructions.
Other Name: Dental adhesive used for bonding fillings

Active Comparator: Adhesive B Device: 3M ESPE Adper Scotchbond 1XT
To be used per manufacturer's instructions.
Other Name: Dental adhesive used for bonding fillings




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00658138


Locations
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Italy
University of Bologna, Clinica Odontoiatrica
Bologna, Italy
Sponsors and Collaborators
3M
Investigators
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Principal Investigator: Giovanni Dondi dall'Orologio, Professor University of Bologna

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Responsible Party: 3M
ClinicalTrials.gov Identifier: NCT00658138     History of Changes
Other Study ID Numbers: CR-07-020
First Posted: April 14, 2008    Key Record Dates
Results First Posted: March 26, 2012
Last Update Posted: March 26, 2012
Last Verified: February 2012
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases