Microbial Sampling of Carious Dentin

Sponsor
University of Utah (Other)
Overall Status
Recruiting
CT.gov ID
NCT04011605
Collaborator
(none)
20
1
59.8
0.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Biological Sample of Carious Dentin

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

Study Type:
Observational
Anticipated Enrollment :
20 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Microbial Sampling of Carious Dentin
Actual Study Start Date :
Jul 8, 2019
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Jul 1, 2024

Outcome Measures

Primary Outcome Measures

  1. Detection of viable microorganisms [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Aged 18-99, Male or Female, No significant systemic illness
Exclusion Criteria:
  • Diabetic, Hypertensive, Pregnant

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Utah School of Dentistry Salt Lake City Utah United States 84108

Sponsors and Collaborators

  • University of Utah

Investigators

  • Principal Investigator: Wyatt R. Hume, DDS, PhD, University of Utah School of Dentistry

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Jul 8, 2019
Last Update Posted:
Oct 4, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 4, 2021