Induced Gingivitis & Intra-oral Imaging

Therapuetic Areas:Dental / Maxillofacial Surgery
Age Range:18 - 35
Start Date:November 5, 2018
End Date:July 2019
Contact:Marilynn Rothen, RDH, MS

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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.

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).

Inclusion Criteria:

- In good general health, ASA I

- No clinical signs of gingival inflammation at >90% sites observed

- Probing Depth(PD) ≤ 3.0 mm

- Attachment Loss (AL) = 0 mm

- Gingival health at baseline visit (Day 0): Gingival Index (GI) ≤ 0.5, Bleeding on
probing (BOP)(-)

- Fluent in English

Exclusion Criteria:

- • Medical condition which requires premedication prior to dental treatments/visits

- Subjects unable or unwilling to undergo informed consent process.

- Subjects currently using anti-gingivitis oral rinses (washout period of 1 week)

- History of periodontal disease

- History of systemic inflammatory or immune conditions

- Use of antibiotic or anti-inflammatory drugs within 30 days of enrollment

- Pregnant or breastfeeding at time of screening

- Concurrent orthodontic treatment

- Untreated carious lesions and/or inadequate restorations, implants, crowns on
maxillary non-molar teeth

- Participation in any other clinical study or test panel within 1 week prior to
enrollment into this study

- Use of tobacco products

- Subjects who must receive dental treatment during the study dates

- Orthodontic bands, appliances, or crowns and bridges, or removable partial
dentures affecting the non-molar maxillary teeth

- Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
We found this trial at
Seattle, Washington 98195
Phone: 206-685-8132
Seattle, WA
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