Clinical trial NCT03750955: Induced Gingivitis & Intra-oral Imaging
Official title: Induced Gingivitis & Intra-oral Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plaque Induced Gingivitis
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Colgate Palmolive
First posted: 2018-11-23
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Split-mouth
Primary purpose: DIAGNOSTIC

Brief 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).

Eligibility criteria: 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)

Primary outcomes:
measure: Change From Baseline Gingivitis at Day 14 as Measured by Non-invasive Microimaging and Gingival Index.
timeFrame: Baseline to Day 14
measure: Change From Day 14 Gingivitis at Day 28 as Measured by Non-invasive Microimaging and Gingival Index.
timeFrame: Day 14 to Day 28
Secondary outcomes:
measure: Change From Baseline Gingivitis at Day 14 as Measured by Non-invasive Microimaging and Plaque Index.
timeFrame: Baseline to Day 14
measure: Change From Day 14 Gingivitis at Day 28 as Measured by Non-invasive Microimaging and Plaque Index.
timeFrame: Day 14 to Day 28
measure: Change From Baseline Angiogenesis Chemokine Concentration at Day 28
timeFrame: Baseline to Day 28
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington School of Dentistry
state: Washington
Study officials:
affiliation: University of Washington
name: Richard P Darveau, MS, PhD
role: PRINCIPAL_INVESTIGATOR
References: