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NCT02885064 Clinical Trial

Shifts in the Oral Biofilm of Patients With Known Oral Health Risk Factors

Dental Caries Clinical Trial

Official title:
Shifts in the Oral Biofilm of Patients With Known Oral Health Risk Factors

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02885064
Other study ID # 16-1624
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 2016
Est. completion date June 22, 2021

Study information
Verified date April 2021
Source University of North Carolina, Chapel Hill
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study is observational only and is intended to evaluate changes in the makeup and function of bacteria naturally present in the mouth during treatment with braces to straighten teeth.

Recruitment information / eligibility
Status Completed
Enrollment 34
Est. completion date June 22, 2021
Est. primary completion date June 22, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 99 Years
Eligibility Inclusion Criteria: - ASA I or II (ASA I is a healthy patient, ASA II is patient with minor systemic disease) - Patient must be receiving orthodontic treatment at the University of North Carolina School of Dentistry and not yet be in active treatment Exclusion Criteria: - Patients who have used antibacterial therapy in the past 3 months - Patients who report current smoking - ASA III or above (Patients with severe systemic diseases)

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States UNC School of Dentistry Chapel Hill North Carolina

Sponsors (1)
Lead Sponsor Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Shannon diversity index from Baseline to Month 6 Baseline, Month 6
Primary Change from Baseline to Month 6 in Clusters Of Orthologous Groups of proteins Baseline, Month 6
Secondary Change in gingival index Baseline, Month 6
Secondary Change in decalcification index Baseline, Month 6
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