Dental CariesNCT00643461
Clinical Evaluation of Three Dental Adhesive Systems in Class V Restorations
An observational study of Dental Caries, run by Solventum US LLC at 1 site in United States.
Trial summary
The purpose of this study is to compare the clinical performance of three dental adhesive systems used to bond Class V cavity fillings in adult teeth. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Dental Caries
- What is being tested?
- Adhesive A, Adhesive B and Adhesive C
- Type of treatment
- Medical device
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Jun 2012
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Class V cavities
Who may be able to join
- Must be at least 19 years of age
- Must have at least 3 qualifying noncarious Class V lesions of appropriate depth
- Must be willing to sign consent form
- Must be willing and able to return to UAB 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
- Severe salivary gland dysfunction
- Rampant caries (cavities)
- Chronic periodontitis (gum disease)
- Known allergies to the study materials
- Unacceptable level of oral hygiene
- Inability or unwillingness to attend study appointments
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham (UAB) School of Dentistry
Birmingham, Alabama, 35294
About this study
The purpose of this study is to compare the clinical performance of three dental adhesive systems used to bond Class V cavity fillings in adult teeth.
- Conditions
- Dental Caries
- Being tested
- Adhesive A, Adhesive B, Adhesive C
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adhesive ADevice
Also called Adper Scotchbond SE (3M ESPE)
Applied per manufacturer's instructions.
Adhesive BDevice
Also called Adper Easy Bond (3M ESPE)
Applied per manufacturer's instructions.
Adhesive CDevice
Also called Single Bond Plus (3M ESPE)
Applied per manufacturer's instructions.
| Study group | Role | What they receive |
|---|---|---|
| Adhesive A | Not described Receives: Device: Adhesive A | |
| Adhesive B | Not described Receives: Device: Adhesive B | |
| Adhesive C | Not described Receives: Device: Adhesive C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention of the restoration.
Measured: 6, 12, 24, 36 months post-placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2008 (estimated)
- Study startApr 2008
- Primary completionFeb 2012
- Study completionJun 2012
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solventum US LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- 3M
- Responsible party
- Sponsor
- Investigators
- John O Burgess, MS, DDS, Principal investigator, University of Alabama at Birmingham (UAB) School of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00643461
- Sponsor's protocol ID
- CR-07-009
- Status last verified
- Sep 2024
- First submitted
- 20 Mar 2008
- 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 Three Dental Adhesive Systems in Class V Restorations
- ClinicalTrials.gov ID
- NCT00643461
- Acronym / sponsor ID
- CR-07-009
- Conditions
- Dental Caries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Solventum US LLCIndustry (pharma, biotech, devices)
- Collaborators
- 3M
- Study start
- Apr 2008
- Primary completion
- Feb 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 26 Mar 2008 (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.
The purpose of this study is to compare the clinical performance of three dental adhesive systems used to bond Class V cavity fillings in adult teeth.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Adhesive A | – | Device: Adhesive A |
| Adhesive B | – | Device: Adhesive B |
| Adhesive C | – | Device: Adhesive C |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Class V cavities
Key inclusion criteria (5 listed)
- Must be at least 19 years of age
- Must have at least 3 qualifying noncarious Class V lesions of appropriate depth
- Must be willing to sign consent form
- Must be willing and able to return to UAB 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
- Severe salivary gland dysfunction
- Rampant caries (cavities)
- Chronic periodontitis (gum disease)
- Known allergies to the study materials
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 |
|---|---|---|
| Adhesive AAlso: Adper Scotchbond SE (3M ESPE)Applied per manufacturer's instructions. | Device | Adhesive A |
| Adhesive BAlso: Adper Easy Bond (3M ESPE)Applied per manufacturer's instructions. | Device | Adhesive B |
| Adhesive CAlso: Single Bond Plus (3M ESPE)Applied per manufacturer's instructions. | Device | Adhesive C |
Primary outcome
Retention of the restoration.
Time frame: 6, 12, 24, 36 months post-placement
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.
John O Burgess, MS, DDS principal investigator
University of Alabama at Birmingham (UAB) School of Dentistry
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 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 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: 6, 12, 24, 36 months post-placement). 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.