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Induced Gingivitis & Intra-oral Imaging

NCT03750955 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2021-03-09

Study results available
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Summary

Using an experimental, non-invasive intra-oral imaging device, this study evaluates the effects on the gingival tissue when oral hygiene is stopped in a section of the mouth for two weeks and gingivitis develops. The effects on the gingival tissue continues to be evaluated as oral hygiene is resumed and the gingival tissue returns to health.

Conditions

  • Plaque Induced Gingivitis

Interventions

DEVICE

Plaque induced gingivitis

Non-invasive microimaging (OTC device) of gingival tissue where oral hygiene cessation utilizing localized stent-induced biofilm overgrowth model (SIBO), will manipulate the participants' oral environment by leading to reversible inflammation of the gingival tissues.

DEVICE

Oral hygiene maintenance

Non-invasive microimaging (OTC device) of gingival tissue where oral hygiene has been maintained by tooth brushing with fluoride toothpaste and flossing twice daily.

Sponsors & Collaborators

Principal Investigators

  • Richard P Darveau, MS, PhD · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-05
Primary Completion
2019-06-03
Completion
2019-06-03
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03750955 on ClinicalTrials.gov