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Non-Invasive Oral Biofilm Characterization

Non-Invasive Oral Biofilm Characterization

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02178046
Enrollment
0
Registered
2014-06-30
Start date
2014-05-23
Completion date
2019-08-12
Last updated
2022-11-01

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

Conditions

Gingivitis

Keywords

Gingivitis

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

Interventions

DEVICEoptical measurements

Laser Speckle Imaging, Optical Coherence Tomography and Multiphoton Microscopy

Sponsors

Beckman Laser Institute University of California Irvine
CollaboratorOTHER
University of California, Irvine
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in gingival perfusionup to 6 weeksoptical measurements

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026