An interventional study of 3M ESPE Adper Scotchbond SE and 3M ESPE Adper Scotchbond 1XT in Dental Caries, sponsored by Solventum US LLC. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-02.
Sponsored by Solventum US LLC · Not applicable, Interventional, and Treatment
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.
1,109 studies on the registry are indexed under Dental Caries; 197 are open to participants now.
This study's enrollment of 61 is close to the median of 60 across 916 interventional studies indexed under Dental Caries.
Browse Dental Caries studies →Solventum US LLC is the lead sponsor of 62 studies on the registry; 2 are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 16 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: 3M ESPE Adper Scotchbond SE
Device: 3M ESPE Adper Scotchbond 1XT
To be used per manufacturer's instructions.
Also known as: Dental adhesive used for bonding fillings
To be used per manufacturer's instructions.
Also known as: Dental adhesive used for bonding fillings
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.
Time frame: 12 months
61 subjects were recruited from 70 patients with a total of 134 study teeth. Recruitment was from December 2008 to April 2009. Subjects were recruited from patients attending PI's clinic
| Milestone | 3M ESPE Adper Scotchbond SE and 3M ESPE Adper Scotchbond 1XT |
|---|---|
| Started | 61 |
| Completed | 40 |
| Not completed | 21 |
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.
| percentage of Alpha scores | Scotchbond SE | Scotchbond 1XT |
|---|---|---|
| Percentage of Restorations Scoring Alpha | 100 | 96 |
Collected over One year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 3M ESPE Adper Scotchbond SE and 3M ESPE Adper Scotchbond 1XT | — | 0/61 (0%) | 0/61 (0%) |
| Age, Categorical(Participants) | 3M ESPE Adper Scotchbond SE and 3M ESPE Adper Scotchbond 1XT |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 61 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | 3M ESPE Adper Scotchbond SE and 3M ESPE Adper Scotchbond 1XT |
|---|---|
| Female | 34 |
| Male | 27 |
| Region of Enrollment(participants) | 3M ESPE Adper Scotchbond SE and 3M ESPE Adper Scotchbond 1XT |
|---|---|
| Italy | 61 |
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Solventum US LLC