Clinical Evaluation of 3M™ ESPE™ Adper™ Scotchbond™ SE Self-Etch Adhesive in Class I and Class II Restorations in Adults
1 other identifier
interventional
61
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2008
Typical duration for not_applicable
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
First Submitted
Initial submission to the registry
April 8, 2008
CompletedFirst Posted
Study publicly available on registry
April 14, 2008
CompletedStudy Start
First participant enrolled
December 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedResults Posted
Study results publicly available
March 26, 2012
CompletedOctober 2, 2024
September 1, 2024
1.9 years
April 8, 2008
December 29, 2011
September 30, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Restorations Scoring Alpha
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
Study Arms (2)
Adhesive A
EXPERIMENTALAdhesive B
ACTIVE COMPARATORInterventions
To be used per manufacturer's instructions.
To be used per manufacturer's instructions.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Solventum US LLClead
- 3Mcollaborator
Study Sites (1)
University of Bologna, Clinica Odontoiatrica
Bologna, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Main limitation of study was small sample size and short duratrion. Study was a pilot of one year's duration.
Results Point of Contact
- Title
- Professor Giovanni Dondi dall'Orologio
- Organization
- University of Bologna, Italy
Study Officials
- PRINCIPAL INVESTIGATOR
Giovanni Dondi dall'Orologio, Professor
University of Bologna
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2008
First Posted
April 14, 2008
Study Start
December 1, 2008
Primary Completion
November 1, 2010
Study Completion
December 1, 2011
Last Updated
October 2, 2024
Results First Posted
March 26, 2012
Record last verified: 2024-09