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Microbial Sampling of Carious Dentin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04011605
Recruitment Status : Not yet recruiting
First Posted : July 8, 2019
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Wyatt R. Hume, DDS PhD, University of Utah

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
Caries,Dental 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.

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Microbial Sampling of Carious Dentin
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : August 2020

Intervention Details:
  • 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.


Primary Outcome Measures :
  1. 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
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Diabetic, Hypertensive, Pregnant

Information from the National Library of Medicine

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


Contacts
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Contact: Lisa Cannon 801-587-3639 lisa.cannon@hsc.utah.edu

Locations
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United States, Utah
University of Utah School of Dentistry
Salt Lake City, Utah, United States, 84108
Contact: Lisa Cannon    801-587-3639    lisa.cannon@hsc.utah.edu   
Principal Investigator: Wyatt R Hume, DDS, PhD         
Sponsors and Collaborators
University of Utah
Investigators
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Principal Investigator: Wyatt R. Hume, DDS, PhD University of Utah School of Dentistry
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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: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases