Clinical Evaluation of a Self-etch Adhesive Using a Selective Etch Technique
Clinical Evaluation of 3M ESPE Adper Easy Bond Self-Etch Adhesive Using a Selective Etch Technique
1 other identifier
observational
40
1 country
1
Brief Summary
Study hypothesis: Etching the enamel followed by use of a self-etching adhesive on enamel and dentin is as effective as a one-step etch and rinse approach.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2011
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 7, 2011
CompletedFirst Posted
Study publicly available on registry
June 8, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedOctober 2, 2024
September 1, 2024
2.1 years
June 7, 2011
September 30, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Retention of the Restoration
Bonded filling still in place
one year
Secondary Outcomes (1)
Clinical performance of the study restoration
one year
Interventions
Bonding composite to restore Class I or Class II cavities
Eligibility Criteria
Dental patients
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Solventum US LLClead
- 3Mcollaborator
Study Sites (1)
School of Dental Medicine
Buffalo, New York, 14214, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carlos Munoz, DDS
Dental Clinic Research Center, School of Dental Medicine, 215 Squire Hall, 3435 Main St, Buffalo, NY 14214
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2011
First Posted
June 8, 2011
Study Start
January 1, 2011
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
October 2, 2024
Record last verified: 2024-09