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

Completed

• Conditions: Gingivitis; Dental Caries

• Registration Number: NCT02885064
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-08-26
• Study First Submitted QC: 2016-08-26
• Study First Posted: 2016-08-31
• Status Verified: 2021-04
• Primary Completion: 2021-06-22
• Study Completion: 2021-06-22
• Last Update Submitted: 2021-11-29
• Last Update Posted: 2021-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change in gingival index	Baseline, Month 6
Change in decalcification index	Baseline, Month 6

Trial Locations

Locations (1)

UNC School of Dentistry; 🇺🇸 Chapel Hill, North Carolina, United States