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Clinical Trials/NCT02885064
NCT02885064
Completed
Not Applicable

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

University of North Carolina, Chapel Hill1 site in 1 country34 target enrollmentAugust 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dental Caries
Sponsor
University of North Carolina, Chapel Hill
Enrollment
34
Locations
1
Primary Endpoint
Change from Baseline to Month 6 in Clusters Of Orthologous Groups of proteins
Status
Completed
Last Updated
4 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
August 2016
End Date
June 22, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Change from Baseline to Month 6 in Clusters Of Orthologous Groups of proteins

Time Frame: Baseline, Month 6

Change in Shannon diversity index from Baseline to Month 6

Time Frame: Baseline, Month 6

Secondary Outcomes

  • Change in gingival index(Baseline, Month 6)
  • Change in decalcification index(Baseline, Month 6)

Study Sites (1)

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