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Clinical Trials/NCT02178046
NCT02178046
Withdrawn
N/A

Non-Invasive Oral Biofilm Characterization

University of California, Irvine1 site in 1 countryMay 23, 2014
ConditionsGingivitis

Overview

Phase
N/A
Intervention
Not specified
Conditions
Gingivitis
Sponsor
University of California, Irvine
Locations
1
Primary Endpoint
Changes in gingival perfusion
Status
Withdrawn
Last Updated
3 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
May 23, 2014
End Date
August 12, 2019
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Beckman Laser Institute and Medical Center

Petra Wilder-Smith, DDS., PhD., Professor, Director of Dentistry

University of California, Irvine

Eligibility Criteria

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

Outcomes

Primary Outcomes

Changes in gingival perfusion

Time Frame: up to 6 weeks

optical measurements

Study Sites (1)

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