Non-Invasive Oral Biofilm Characterization

Withdrawn

• Conditions: Gingivitis
• Interventions: Device: optical measurements

• Registration Number: NCT02178046
• Lead Sponsor: University of California, Irvine

Brief Summary

There is a need for toothpastes that more effectively remove oral plaque and prevent re-formation. The objective of this study is to map the development and resolution of clinical gingivitis using conventional clinical examination and imaging data to determine how useful imaging techniques can be for evaluating how well a toothpaste cleans the teeth

Detailed Description

The researcher can use imaging techniques to map changes in gingival blood flow during the development and resolution of fully reversible, early clinical gingivitis using standard-of-care clinical indices as gold standard

The researcher can use imaging techniques to map inflammatory microstructural changes in the oral mucosa including swelling, vasodilation and edema during the development and resolution of fully reversible, early clinical gingivitis using standard-of-care clinical indices as gold standard

Study Timeline

• Study Start: 2014-05-23
• Study First Submitted: 2014-06-26
• Study First Submitted QC: 2014-06-26
• Study First Posted: 2014-06-30
• Primary Completion: 2019-08-12
• Study Completion: 2019-08-12
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-28
• Last Update Posted: 2022-11-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Adult male or female 18-25 years of age
• Volunteers with gingivitis but no periodontitis

Exclusion Criteria

• Subjects who must receive dental treatment during the study dates.
• History of significant adverse effects following use of oral hygiene products such as toothpastes and mouth rinses. Allergy to personal care/consumer products or their ingredients.
• Individuals who have taken antibiotics in the previous 3 months
• Individuals who are pregnant or nursing

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Gingivitis	optical measurements	optical measurements

Primary Outcome Measures

Name	Time	Method
Changes in gingival perfusion	up to 6 weeks	optical measurements

Trial Locations

Locations (1)

Beckman Laser Institute; 🇺🇸 Irvine, California, United States