NCT03750955

Induced Gingivitis & Intra-oral Imaging

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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.

Detailed description

The study will include the following phases - 1) Hygiene phase of 2 weeks; 2) Gingivitis induction phase with stent lasting up to 2 weeks; and 3) Resolution phase of 2 weeks. The intervention will consist of cessation of oral hygiene versus an active control of oral hygiene with a fluoridated toothpaste. This study is a modification of classical experimental gingivitis model. The study will prospectively enroll subjects and assign a maxillary sextant to the intervention, while the other sextant will serve as control in a split-mouth design of localized experimental gingivitis, utilizing localized stent-induced biofilm overgrowth model (SIBO). The intervention, i.e. oral hygiene cessation will manipulate the participants' oral environment by leading to reversible inflammation of the gingival tissues. The purpose of this study is to evaluate the effects of oral hygiene cessation in the gingival tissues by an innovative non-invasive microimaging technique, i.e. Optical coherence tomography (OCT).

Conditions

• Plaque Induced Gingivitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-11-05
• Primary completion: 2019-06-03
• Completion: 2019-06-03
• First posted: 2018-11-23
• Last updated: 2021-03-09
• Results posted: 2021-03-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study