Microbial Sampling of Carious Dentin
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ClinicalTrials.gov Identifier: NCT04011605 |
Recruitment Status :
Withdrawn
(No longer moving forward with study as of May 2022)
First Posted : July 8, 2019
Last Update Posted : May 10, 2023
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Condition or disease | Intervention/treatment |
---|---|
Caries,Dental | Procedure: Biological Sample of Carious Dentin |
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 Type : | Observational |
Actual Enrollment : | 0 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Microbial Sampling of Carious Dentin |
Actual Study Start Date : | July 8, 2019 |
Actual Primary Completion Date : | May 11, 2022 |
Actual Study Completion Date : | May 11, 2022 |
- Procedure: Biological Sample of Carious Dentin
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.
- 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.
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Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Aged 18-99, Male or Female, No significant systemic illness
Exclusion Criteria:
- Diabetic, Hypertensive, Pregnant
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04011605
United States, Utah | |
University of Utah School of Dentistry | |
Salt Lake City, Utah, United States, 84108 |
Principal Investigator: | Wyatt R. Hume, DDS, PhD | University of Utah School of Dentistry |
Responsible Party: | Wyatt R. Hume, DDS PhD, Dean, School of Dentistry, University of Utah |
ClinicalTrials.gov Identifier: | NCT04011605 |
Other Study ID Numbers: |
00121555 |
First Posted: | July 8, 2019 Key Record Dates |
Last Update Posted: | May 10, 2023 |
Last Verified: | May 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Dental Caries Tooth Demineralization Tooth Diseases Stomatognathic Diseases |