Non-Invasive Oral Biofilm Characterization

Gingivitis Clinical Trial

Official title:

Non-Invasive Oral Biofilm Characterization

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02178046
• Other study ID #: 20141167
• Status: Withdrawn
• Start date: May 23, 2014
• Est. completion date: August 12, 2019

Study information

• Verified date: October 2022
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 12, 2019
• Est. primary completion date: August 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Gingivitis

Intervention

Device:
• optical measurements
Laser Speckle Imaging, Optical Coherence Tomography and Multiphoton Microscopy

Locations

Country	Name	City	State
United States	Beckman Laser Institute	Irvine	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Irvine	Beckman Laser Institute University of California Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in gingival perfusion	optical measurements	up to 6 weeks