Non-Invasive Oral Biofilm Characterization

Sponsor

University of California, Irvine (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02178046

Collaborator

Beckman Laser Institute University of California Irvine (Other)

Enrollment

Location

62.7

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

0 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Non-Invasive Oral Biofilm Characterization

Actual Study Start Date :

May 23, 2014

Actual Primary Completion Date :

Aug 12, 2019

Actual Study Completion Date :

Aug 12, 2019

Arms and Interventions

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

Arm

Intervention/Treatment

Gingivitis

optical measurements

Device: optical measurements

Laser Speckle Imaging, Optical Coherence Tomography and Multiphoton Microscopy

Outcome Measures

Primary Outcome Measures

Changes in gingival perfusion [up to 6 weeks]
optical measurements

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 25 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beckman Laser Institute	Irvine	California	United States	92612

Sponsors and Collaborators

University of California, Irvine
Beckman Laser Institute University of California Irvine

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of California, Irvine

ClinicalTrials.gov Identifier:

NCT02178046

Other Study ID Numbers:

NIH/LAMMP-2014-1167

First Posted:

Jun 30, 2014

Last Update Posted:

Mar 30, 2021

Last Verified:

Mar 1, 2021

Keywords provided by University of California, Irvine

Gingivitis

Additional relevant MeSH terms:

Gingivitis

Study Results

No Results Posted as of Mar 30, 2021