Dental Caries
Conditions
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.
Interventions
DEVICE3M ESPE Adper Scotchbond SE
To be used per manufacturer's instructions.
DEVICE3M ESPE Adper Scotchbond 1XT
To be used per manufacturer's instructions.
Sponsors
3M
Solventum US LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Restorations Scoring Alpha | 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. |
Countries
Italy
Participant flow
Recruitment details
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
Pre-assignment details
All enrolled participants took part in the study
Participants by arm
| Arm | Count |
|---|---|
| 3M ESPE Adper Scotchbond SE and 3M ESPE Adper Scotchbond 1XT 67 teeth in 61 subjects had 3M ESPE Adper Scotchbond SE 67 teeth in 61 subjects had 3M ESPE Adper Scotchbond 1XT | 61 |
| Total | 61 |
Baseline characteristics
| Characteristic | 3M ESPE Adper Scotchbond SE and 3M ESPE Adper Scotchbond 1XT |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 61 Participants |
| Region of Enrollment Italy | 61 participants |
| Sex: Female, Male Female | 34 Participants |
| Sex: Female, Male Male | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 61 |
| serious Total, serious adverse events | 0 / 61 |
Outcome results
Primary
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
Population: Analysis was based on the number of study teeth available for review at 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Scotchbond SE | Percentage of Restorations Scoring Alpha | 100 percentage of Alpha scores |
| Scotchbond 1XT | Percentage of Restorations Scoring Alpha | 96 percentage of Alpha scores |
Comparison: Hypothesis was no difference between adhesives tested at one year. Restorations were scored using USPHS subjective clinical criteria.p-value: 0.05Wilcoxon (Mann-Whitney)
Comparison: Null hypothesis is adhesives are not different in clinical performance at one yearp-value: >0.05Wilcoxon (Mann-Whitney)