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OpenTrials
Completed

NCT Number: NCT02885064

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

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.

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Key information

Conditions

Dental Caries Gingival Diseases Gingivitis Infections Mouth Diseases Periodontal Diseases Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

8 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UNC School of Dentistry

Chapel Hill, North Carolina, 27599, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  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 outcomes

  1. Change in gingival index

    Time frame: Baseline, Month 6

  2. Change in decalcification index

    Time frame: Baseline, Month 6

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Aug 31, 2016
Registry last updated
Dec 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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