Non-Invasive Oral Biofilm Characterization

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-23

Study Completion Date

2019-08-12

Brief Summary

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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

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Detailed Description

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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

Conditions

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Gingivitis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Gingivitis

optical measurements

Intervention Type DEVICE

Laser Speckle Imaging, Optical Coherence Tomography and Multiphoton Microscopy

Interventions

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optical measurements

Laser Speckle Imaging, Optical Coherence Tomography and Multiphoton Microscopy

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No