Dental CariesNCT00658138
Clinical Evaluation of 3M™ ESPE™ Adper™ Scotchbond™ SE Self-Etch Adhesive in Class I and Class II Restorations in Adults
A study testing 3M ESPE Adper Scotchbond SE and 3M ESPE Adper Scotchbond 1XT in people with Dental Caries, run by Solventum US LLC at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Caries
- What is being tested?
- 3M ESPE Adper Scotchbond SE and 3M ESPE Adper Scotchbond 1XT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2008to Dec 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Dental Caries
- Being tested
- 3M ESPE Adper Scotchbond SE, 3M ESPE Adper Scotchbond 1XT
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3M ESPE Adper Scotchbond SEDevice
Also called Dental adhesive used for bonding fillings
To be used per manufacturer's instructions.
3M ESPE Adper Scotchbond 1XTDevice
Also called Dental adhesive used for bonding fillings
To be used per manufacturer's instructions.
| Study group | Role | What they receive |
|---|---|---|
| Adhesive A | Experimental | Not described Receives: Device: 3M ESPE Adper Scotchbond SE |
| Adhesive B | Active comparator | Not described Receives: Device: 3M ESPE Adper Scotchbond 1XT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2008 (estimated)
- Study startDec 2008
- Primary completionNov 2010
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solventum US LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- 3M
- Responsible party
- Sponsor
- Investigators
- Giovanni Dondi dall'Orologio, Professor, Principal investigator, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00658138
- Sponsor's protocol ID
- CR-07-020
- Status last verified
- Sep 2024
- First submitted
- 8 Apr 2008
- Last updated
- 2 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of 3M™ ESPE™ Adper™ Scotchbond™ SE Self-Etch Adhesive in Class I and Class II Restorations in Adults
- ClinicalTrials.gov ID
- NCT00658138
- Acronym / sponsor ID
- CR-07-020
- Conditions
- Dental Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Solventum US LLCIndustry (pharma, biotech, devices)
- Collaborators
- 3M
- Study start
- Dec 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 14 Apr 2008 (estimated)
- Results
- Posted 26 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adhesive A | Experimental | Device: 3M ESPE Adper Scotchbond SE |
| Adhesive B | Active comparator | Device: 3M ESPE Adper Scotchbond 1XT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- Current participation in other restorative product studies
- Known allergies to dental products
- Unacceptable level of oral hygiene
- Chronic periodontitis (gum disease)
- Rampant caries (cavities)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3M ESPE Adper Scotchbond SEAlso: Dental adhesive used for bonding fillingsTo be used per manufacturer's instructions. | Device | Adhesive A |
| 3M ESPE Adper Scotchbond 1XTAlso: Dental adhesive used for bonding fillingsTo be used per manufacturer's instructions. | Device | Adhesive B |
Primary outcome
Percentage of Restorations Scoring Alpha
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giovanni Dondi dall'Orologio, Professor principal investigator
University of Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3M ESPE Adper Scotchbond SE and 3M ESPE Adper Scotchbond 1XT in people with Dental Caries, run by Solventum US LLC at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Restorations Scoring Alpha (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024.