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

Sponsor
University of North Carolina, Chapel Hill (Other)
Overall Status
Completed
CT.gov ID
NCT02885064
Collaborator
(none)
34
Enrollment
1
Location
58.7
Actual Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    34 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Shifts in the Oral Biofilm of Patients With Known Oral Health Risk Factors
    Actual Study Start Date :
    Aug 1, 2016
    Actual Primary Completion Date :
    Jun 22, 2021
    Actual Study Completion Date :
    Jun 22, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Change in Shannon diversity index from Baseline to Month 6 [Baseline, Month 6]

    2. Change from Baseline to Month 6 in Clusters Of Orthologous Groups of proteins [Baseline, Month 6]

    Secondary Outcome Measures

    1. Change in gingival index [Baseline, Month 6]

    2. Change in decalcification index [Baseline, Month 6]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    8 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UNC School of Dentistry Chapel Hill North Carolina United States 27599

    Sponsors and Collaborators

    • University of North Carolina, Chapel Hill

    Investigators

    • Principal Investigator: Laura Jacox, DMD, PhD, MS, University of North Carolina, Chapel Hill

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of North Carolina, Chapel Hill
    ClinicalTrials.gov Identifier:
    NCT02885064
    Other Study ID Numbers:
    • 16-1624
    First Posted:
    Aug 31, 2016
    Last Update Posted:
    Dec 14, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Additional relevant MeSH terms:
    Gingivitis
    Dental Caries

    Study Results

    No Results Posted as of Dec 14, 2021