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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01369134 |
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Date of registration:
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07/06/2011 |
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Primary sponsor: |
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Public title:
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Clinical Evaluation of a Self-etch Adhesive Using a Selective Etch Technique
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Scientific title:
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Clinical Evaluation of 3M ESPE Adper Easy Bond Self-Etch Adhesive Using a Selective Etch Technique |
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Date of first enrolment:
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January 2011 |
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Target sample size:
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40 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01369134 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Carlos Munoz, DDS |
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Address:
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Telephone:
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Email:
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Affiliation:
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Dental Clinic Research Center, School of Dental Medicine, 215 Squire Hall, 3435 Main St, Buffalo, NY 14214 |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 18 years or older
- written informed consent
- regular dental attender, can return to clinic for study recalls
- good medical health
- normal saliva flow
- has one or two pairs of back teeth that require a Class I or II restoration of
appropriate size
- study teeth that are vital
Exclusion Criteria:
- currently in an evaluation of other dental materials
- an irregular dental attender
- has unacceptable oral hygiene standards
- has chronic periodontitis or rampant caries
- has teeth with signs of periapical pathology
- has history of pulp problems, and/or needs pulp treatment
- women who are pregnant or breast-feeding
- has known allergy to resin composite or latex
- has serious chronic disease requiring hospitalization
- has oral soft tissue pathologies
- takes medications which, in the opinion of the investigator, could interfere with the
conduct of the study
- has current or recent history of alcohol or other substance abuse
- is an employee of the sponsor or the study site, or members of their immediate family
- has had any restorative treatment of teeth involved in the study in the last twelve
months
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Dental Caries
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Intervention(s)
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Device: Adper Easy Bond Self-etch dental adhesive
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Primary Outcome(s)
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Retention of the Restoration
[Time Frame: one year]
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Secondary Outcome(s)
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Clinical performance of the study restoration
[Time Frame: one year]
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Secondary ID(s)
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CR-10-014
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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