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Non-Invasive Oral Biofilm Characterization

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02178046
Recruitment Status : Recruiting
First Posted : June 30, 2014
Last Update Posted : February 25, 2019
Sponsor:
Collaborator:
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, 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

Condition or disease Intervention/treatment
Gingivitis Device: optical measurements

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

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Month
Official Title: Non-Invasive Oral Biofilm Characterization
Study Start Date : June 2014
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

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




Primary Outcome Measures :
  1. Changes in gingival perfusion [ Time Frame: up to 6 weeks ]
    optical measurements



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02178046


Contacts
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Contact: Petra Wilder-Smith, DDS.PhD 949-824-9265
Contact: Montana Compton, RN 949-824-9265 mocomton@uci.edu

Locations
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United States, California
Beckman Laser Institute Recruiting
Irvine, California, United States, 92612
Contact: Montana Compton, RN    949-824-9265    mocomton@uci.edu   
Principal Investigator: Petra Wilder-Smith, DDS, PhD         
Sub-Investigator: Montana Compton, RN         
Sponsors and Collaborators
University of California, Irvine
Beckman Laser Institute University of California Irvine
Investigators
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Principal Investigator: Petra Wilder-Smith, DDS. PhD Beckman Laser Institute, UCI
Additional Information:

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Responsible Party: Beckman Laser Institute and Medical Center, Petra Wilder-Smith, DDS., PhD., Professor, Director of Dentistry, University of California, Irvine
ClinicalTrials.gov Identifier: NCT02178046    
Other Study ID Numbers: NIH/LAMMP-2014-1167
First Posted: June 30, 2014    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019
Keywords provided by Beckman Laser Institute and Medical Center, University of California, Irvine:
Gingivitis
Additional relevant MeSH terms:
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Gingivitis
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases