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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02885064

Enrollment

Registered

2016-08-31

Start date

2016-08-31

Completion date

2021-06-22

Last updated

2021-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries, Gingivitis

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

8 Years to 99 Years

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)

Design outcomes

Primary

Measure	Time frame
Change in Shannon diversity index from Baseline to Month 6	Baseline, Month 6
Change from Baseline to Month 6 in Clusters Of Orthologous Groups of proteins	Baseline, Month 6

Secondary

Measure	Time frame
Change in gingival index	Baseline, Month 6
Change in decalcification index	Baseline, Month 6

Countries

United States

Outcome results