Study Stopped
No longer moving forward with study as of May 2022
Microbial Sampling of Carious Dentin
1 other identifier
observational
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jul 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 3, 2019
CompletedFirst Posted
Study publicly available on registry
July 8, 2019
CompletedStudy Start
First participant enrolled
July 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 11, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 11, 2022
CompletedMay 10, 2023
May 1, 2023
2.8 years
July 3, 2019
May 8, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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.
1 year from study start date
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- Aged 18-99, Male or Female, No significant systemic illness
You may not qualify if:
- Diabetic, Hypertensive, Pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Utah School of Dentistry
Salt Lake City, Utah, 84108, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wyatt R. Hume, DDS, PhD
University of Utah School of Dentistry
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dean, School of Dentistry
Study Record Dates
First Submitted
July 3, 2019
First Posted
July 8, 2019
Study Start
July 8, 2019
Primary Completion
May 11, 2022
Study Completion
May 11, 2022
Last Updated
May 10, 2023
Record last verified: 2023-05