Clinical trial NCT04011605: Microbial Sampling of Carious Dentin
Official title: Microbial Sampling of Carious Dentin
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Caries,Dental
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2019-07-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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). 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.

Eligibility criteria: Inclusion Criteria:

* Aged 18-99, Male or Female, No significant systemic illness

Exclusion Criteria:

* Diabetic, Hypertensive, Pregnant

Primary outcomes:
measure: Detection of viable microorganisms
timeFrame: 1 year from study start date
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah School of Dentistry
state: Utah
Study officials:
affiliation: University of Utah School of Dentistry
name: Wyatt R. Hume, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: