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

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ClinicalTrials.gov Identifier: NCT02885064
Recruitment Status : Recruiting
First Posted : August 31, 2016
Last Update Posted : December 13, 2017
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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
Dental Caries Gingivitis

Study Type : Observational
Estimated Enrollment : 120 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 : August 2016
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dental Health




Primary Outcome Measures :
  1. Change in Shannon diversity index from Baseline to Month 6 [ Time Frame: Baseline, Month 6 ]
  2. Change from Baseline to Month 6 in Clusters Of Orthologous Groups of proteins [ Time Frame: Baseline, Month 6 ]

Secondary Outcome Measures :
  1. Change in gingival index [ Time Frame: Baseline, Month 6 ]
  2. Change in decalcification index [ Time Frame: Baseline, Month 6 ]

Biospecimen Retention:   Samples With DNA
bacteria isolated from plaque and saliva; human genome


Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients entering and then undergoing orthodontic treatment
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)

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): NCT02885064


Contacts
Contact: Tate Jackson, DDS, MS 919-537-3775 tatejackson@unc.edu

Locations
United States, North Carolina
UNC School of Dentistry Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Tate H Jackson, DDS, MS    919-537-3775    tatejackson@unc.edu   
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Tate Jackson, DDS, MS University of North Carolina, Chapel Hill

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02885064     History of Changes
Other Study ID Numbers: 16-1624
First Posted: August 31, 2016    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Dental Caries
Gingivitis
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Gingival Diseases
Periodontal Diseases
Mouth Diseases