Caries,DentalNCT04011605
Microbial Sampling of Carious Dentin
An observational study of Caries,Dental, run by University of Utah at 1 site in United States.
Trial summary
The School of Dentistry is seeking to determine whether viable microorganisms remain within tooth structure after conventional, mechanical removal of areas of tooth decay, prior to placement or replacement of tooth restorations (fillings). Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries,Dental
- What is being tested?
- Biological Sample of Carious Dentin
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2019to 11 May 2022
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The School of Dentistry will seek dental patient volunteers to participate in the study if patient meets all inclusion and exclusion criteria and is in need of a Class II filling placement. Flyers will be placed in the reception area of the School of Dentistry clinic. Student dentists will also inform study staff if he/she has a patient who meets the inclusion and exclusion criteria of the study. Study staff will approach the patient to seek informed consent.
Who may be able to join
- Aged 18-99, Male or Female, No significant systemic illness
Who cannot join
- Diabetic, Hypertensive, Pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah School of Dentistry
Salt Lake City, Utah, 84108
About this study
The School of Dentistry is seeking to determine whether viable microorganisms remain within tooth structure after conventional, mechanical removal of areas of tooth decay, prior to placement or replacement of tooth restorations (fillings). The long-term goal of the work is to decrease the failure rate, and therefore increase the longevity, of tooth restorations (fillings) in human patients and populations.
Read the detailed description
It is proposed that with informed consent, and in a sterile operating environment (controlled, micron level-filtered environmental air flow, in addition to conventional instrument sterilization) dental patient volunteers will have either areas of decayed tooth structure or recurrent caries defective fillings removed using conventional, routine procedures, which will include: local anesthesia; tooth isolation using rubber dam; removal of superficial decay, weakened tooth structure or defective filling materials with rotary tooth cutting instruments; and then removal of softened dentin using sterile sharp spoon excavators, by hand. The limit of dentin removal will be determined by the clinician's estimate of tooth hardness, that is, using present conventional and ethical practice. This last step, removal of tissue guided by estimated hardness, is as described above the universally accepted standard.
Following removal, the exposed dentin surface will be examined visually with an 15X operating microscope to detect any areas of discolored dentin. Any such areas will be micro-sampled using ultra slow-speed, 0.2 mm diameter rotary cutting instruments and removal of resultant dentin flakes with sterile fibers. Each prepared cavity will then be restored using conventional tooth filling materials and techniques.
Immediately after removal each dentin flake will be weighed, placed into bacterial transport medium, then sonicated. The transport medium will be divided in two, and separate samples added to bacterial growth medium under anaerobic and aerobic growth conditions. Any viable microorganisms detected will be identified both by conventional plating techniques using visual identification, and by a commercial laboratory using RNA analysis.
- Conditions
- Caries,Dental
- Being tested
- Biological Sample of Carious Dentin
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological Sample of Carious DentinProcedure or surgery
Dental patient volunteers will have either areas of decayed tooth structure or recurrent caries defective fillings removed using conventional, routine procedures, which will include: local anesthesia; tooth isolation using rubber dam; removal of superficial decay, weakened tooth structure or defective filling materials with rotary tooth cutting instruments; and then removal of softened dentin using sterile sharp spoon excavators, by hand. The limit of dentin removal will be determined by the clinician's estimate of tooth hardness, that is, using present conventional and ethical practice.
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of viable microorganisms
Should viable microorganisms be detected within tooth structure after conventional, mechanical removal of decayed areas, future studies into the potential effectiveness of various topical antibacterial agents may well follow.
Measured: 1 year from study start date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start8 Jul 2019
- Primary completion11 May 2022
- Study completion11 May 2022
Why it stopped: No longer moving forward with study as of May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caries,DentalStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wyatt R. Hume, DDS PhD, University of Utah
- Investigators
- Wyatt R. Hume, DDS, PhD, Principal investigator, University of Utah School of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04011605
- Sponsor's protocol ID
- 00121555
- Status last verified
- May 2023
- First submitted
- 3 Jul 2019
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbial Sampling of Carious Dentin
- ClinicalTrials.gov ID
- NCT04011605
- Acronym / sponsor ID
- 00121555
- Conditions
- Caries,Dental
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No longer moving forward with study as of May 2022
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 8 Jul 2019 (actual)
- Primary completion
- 11 May 2022 (actual)
- Study completion
- 11 May 2022 (actual)
- First posted
- 8 Jul 2019 (actual)
- 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 School of Dentistry is seeking to determine whether viable microorganisms remain within tooth structure after conventional, mechanical removal of areas of tooth decay, prior to placement or replacement of tooth restorations (fillings). The long-term goal of the work is to decrease the failure rate, and therefore increase the longevity, of tooth restorations (fillings) in human patients and populations.
Detailed description
It is proposed that with informed consent, and in a sterile operating environment (controlled, micron level-filtered environmental air flow, in addition to conventional instrument sterilization) dental patient volunteers will have either areas of decayed tooth structure or recurrent caries defective fillings removed using conventional, routine procedures, which will include: local anesthesia; tooth isolation using rubber dam; removal of superficial decay, weakened tooth structure or defective filling materials with rotary tooth cutting instruments; and then removal of softened dentin using sterile sharp spoon excavators, by hand. The limit of dentin removal will be determined by the clinician's estimate of tooth hardness, that is, using present conventional and ethical practice. This last step, removal of tissue guided by estimated hardness, is as described above the universally accepted standard.
Following removal, the exposed dentin surface will be examined visually with an 15X operating microscope to detect any areas of discolored dentin. Any such areas will be micro-sampled using ultra slow-speed, 0.2 mm diameter rotary cutting instruments and removal of resultant dentin flakes with sterile fibers. Each prepared cavity will then be restored using conventional tooth filling materials and techniques.
Immediately after removal each dentin flake will be weighed, placed into bacterial transport medium, then sonicated. The transport medium will be divided in two, and separate samples added to bacterial growth medium under anaerobic and aerobic growth conditions. Any viable microorganisms detected will be identified both by conventional plating techniques using visual identification, and by a commercial laboratory using RNA analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The School of Dentistry will seek dental patient volunteers to participate in the study if patient meets all inclusion and exclusion criteria and is in need of a Class II filling placement. Flyers will be placed in the reception area of the School of Dentistry clinic. Student dentists will also inform study staff if he/she has a patient who meets the inclusion and exclusion criteria of the study. Study staff will approach the patient to seek informed consent.
Key inclusion criteria (1 listed)
- Aged 18-99, Male or Female, No significant systemic illness
Key exclusion criteria (1 listed)
- Diabetic, Hypertensive, Pregnant
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 |
|---|---|---|
| Biological Sample of Carious DentinDental patient volunteers will have either areas of decayed tooth structure or recurrent caries defective fillings removed using conventional, routine procedures, which will include: local anesthesia; tooth isolation using rubber dam; removal of superficial decay, weakened tooth structure or defective filling materials with rotary tooth cutting instruments; and then removal of softened dentin using sterile sharp spoon excavators, by hand. The limit of dentin removal will be determined by the clinician's estimate of tooth hardness, that is, using present conventional and ethical practice. | Procedure or surgery | – |
Primary outcome
Detection of viable microorganisms
Time frame: 1 year from study start date
Should viable microorganisms be detected within tooth structure after conventional, mechanical removal of decayed areas, future studies into the potential effectiveness of various topical antibacterial agents may well follow.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Individual participant dataSharing planned: Undecided
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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.
Wyatt R. Hume, DDS, PhD principal investigator
University of Utah 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 Caries,Dental, run by University of Utah 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 10 May 2023. 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 was withdrawn before enrolling participants, so there are no results.
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?
Detection of viable microorganisms (time frame: 1 year from study start date). 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 10 May 2023.