Dental CariesNCT01369134
Clinical Evaluation of a Self-etch Adhesive Using a Selective Etch Technique
An observational study of Dental Caries, run by Solventum US LLC at 1 site in United States.
Trial 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. 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?
- Adper Easy Bond Self-etch dental adhesive
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Feb 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Dental patients
Who may be able to join
- 18 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of 3M ESPE Adper Easy Bond Self-Etch Adhesive Using a Selective Etch Technique
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.
Read the detailed description
There is scant evidence available on the performance of self-etching dental adhesive systems. This study aims to clinically evaluate a self-etch adhesive used either with an extra enamel etching step, or in a self-etch stand alone technique with no extra enamel etch.
- Conditions
- Dental Caries
- Being tested
- Adper Easy Bond Self-etch dental adhesive
- Keywords
- self-etch adhesive, selective enamel etching, Adper Easy Bond, Supreme Ultra, Molar and premolar teeth, Adult, Class I and II cavities
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adper Easy Bond Self-etch dental adhesiveDevice
Also called self etch adhesive with enamel etch
Bonding composite to restore Class I or Class II cavities
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention of the Restoration
Bonded filling still in place
Measured: one year
Secondary outcomes (1)
Clinical performance of the study restoration
Restoration in satisfactory clinical function at one year
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2011 (estimated)
- Study startJan 2011
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solventum US LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- 3M
- Responsible party
- Sponsor
- Investigators
- Carlos Munoz, DDS, Principal investigator, Dental Clinic Research Center, School of Dental Medicine, 215 Squire Hall, 3435 Main St, Buffalo, NY 14214
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01369134
- Sponsor's protocol ID
- CR-10-014
- Status last verified
- Sep 2024
- First submitted
- 7 Jun 2011
- Last updated
- 2 Oct 2024
- Results posted
- No
- 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 Easy Bond Self-Etch Adhesive Using a Selective Etch Technique
- ClinicalTrials.gov ID
- NCT01369134
- Acronym / sponsor ID
- CR-10-014
- Conditions
- Dental Caries
- Keywords
- self-etch adhesive, selective enamel etching, Adper Easy Bond, Supreme Ultra, Molar and premolar teeth, Adult, Class I and II cavities
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Solventum US LLCIndustry (pharma, biotech, devices)
- Collaborators
- 3M
- Study start
- Jan 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 8 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
There is scant evidence available on the performance of self-etching dental adhesive systems. This study aims to clinically evaluate a self-etch adhesive used either with an extra enamel etching step, or in a self-etch stand alone technique with no extra enamel etch.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Dental patients
Key inclusion criteria (7 listed)
- 18 years or older
- written informed consent
- regular dental attender, can return to clinic for study recalls
- good medical health
- normal saliva flow
Key exclusion criteria (14 listed)
- 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
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 |
|---|---|---|
| Adper Easy Bond Self-etch dental adhesiveAlso: self etch adhesive with enamel etchBonding composite to restore Class I or Class II cavities | Device | – |
Primary outcome
Retention of the Restoration
Time frame: one year
Bonded filling still in place
1 secondary outcome
Clinical performance of the study restoration
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
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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.
Carlos Munoz, DDS principal investigator
Dental Clinic Research Center, School of Dental Medicine, 215 Squire Hall, 3435 Main St, Buffalo, NY 14214
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Caries, run by Solventum US LLC at 1 site in United States.
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 7 inclusion and 14 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Retention of the Restoration (time frame: one year). 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.