Non-Invasive Oral Biofilm Characterization

October 28, 2022 updated by: Beckman Laser Institute and Medical Center, University of California, Irvine
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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Irvine, California, United States, 92612
        • Beckman Laser Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 25 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Study population will be selected from UCI Medical Center a referral base for dentists in the greater Orange County area for diagnosis of patients with suspected intra-oral lesions. The UCI student dental health clinic caters to UCI students, staff and faculty.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Gingivitis
optical measurements
Device: optical measurements
Laser Speckle Imaging, Optical Coherence Tomography and Multiphoton Microscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in gingival perfusion
Time Frame: up to 6 weeks
optical measurements
up to 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Irvine

Collaborators

Beckman Laser Institute University of California Irvine

Investigators

  • Principal Investigator: Petra Wilder-Smith, DDS. PhD, Beckman Laser Institute, UCI

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2014

Primary Completion (Actual)

August 12, 2019

Study Completion (Actual)

August 12, 2019

Study Registration Dates

First Submitted

June 26, 2014

First Submitted That Met QC Criteria

June 26, 2014

First Posted (Estimate)

June 30, 2014

Study Record Updates

Last Update Posted (Actual)

November 1, 2022

Last Update Submitted That Met QC Criteria

October 28, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20141167

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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