Non-Invasive Oral Biofilm Characterization

NCT02178046 | Withdrawn

• 1 other identifier: 20141167
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Gingivitis

Keywords

Gingivitis

Outcome Measures

Primary Outcomes (1)

• Changes in gingival perfusion

  optical measurements

  up to 6 weeks

Study Arms (1)

Gingivitis

optical measurements

Device: optical measurements

Interventions

optical measurements DEVICE

Laser Speckle Imaging, Optical Coherence Tomography and Multiphoton Microscopy

Gingivitis

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Adult male or female 18-25 years of age
• Volunteers with gingivitis but no periodontitis

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Irvine: lead
• Beckman Laser Institute University of California Irvine: collaborator

Study Sites (1)

Beckman Laser Institute

Irvine, California, 92612, United States

Location

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Petra Wilder-Smith, DDS. PhD

  Beckman Laser Institute, UCI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Petra Wilder-Smith, DDS., PhD., Professor, Director of Dentistry

Study Record Dates

• First Submitted: June 26, 2014
• First Posted: June 30, 2014
• Study Start: May 23, 2014
• Primary Completion: August 12, 2019
• Study Completion: August 12, 2019
• Last Updated: November 1, 2022

Record last verified: 2022-10

Locations

US (1)