Induced Gingivitis & Intra-oral Imaging

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Induced Gingivitis & Intra-oral Imaging

Conditions
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Plaque Induced Gingivitis

Intervention / Treatment
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* Device: Plaque induced gingivitis
* Device: Oral hygiene maintenance


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Split-mouth
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Plaque induced gingivitis<br>Non-invasive microimaging (OTC device) of gingival tissue where plaque induced gingivitis results from a cessation of oral hygiene in a sextant using a stent-induced biofilm overgrowth model. | Device: Plaque induced gingivitis<br>* 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.<br>* Other names: Cessation of oral hygiene;|
| Active Comparator: Oral hygiene maintenance<br>Non-invasive microimaging (OTC device) of gingival tissue where oral hygiene (tooth brushing with fluoride toothpaste and flossing twice daily) is maintained. | Device: Oral hygiene maintenance<br>* Non-invasive microimaging (OTC device) of gingival tissue where oral hygiene has been maintained by tooth brushing with fluoride toothpaste and flossing twice daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline Gingivitis at Day 14 as Measured by Non-invasive Microimaging and Gingival Index. | The predictive validity of a non-invasive microimaging technique for assessing experimental gingivitis (plaque induced), as compared with gingival index is not reported. The microimaging technique was used to measure changes in the gingival thickness of the inter-dental tooth area. This area measured did not represent the clinical status of the tissue surrounding the tooth. The gingival index is reported. Loe and Silness Gingival Index (GI); scale: 0 = normal gingiva, 1 = mild inflammation, 2 = moderate inflammation, 3 = severe inflammation | Baseline to Day 14 | 
| Change From Day 14 Gingivitis at Day 28 as Measured by Non-invasive Microimaging and Gingival Index. | The predictive validity of a non-invasive microimaging technique for assessing experimental gingivitis (plaque induced), as compared with gingival index is not reported. The microimaging technique was used to measure changes in the gingival thickness of the inter-dental tooth area. This area measured did not represent the clinical status of the tissue surrounding the tooth. The gingival index is reported. Loe and Silness Gingival Index (GI); scale: 0 = normal gingiva, 1 = mild inflammation, 2 = moderate inflammation, 3 = severe inflammation | Day 14 to Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline Gingivitis at Day 14 as Measured by Non-invasive Microimaging and Plaque Index. | The predictive validity of a microimaging technique for assessing experimental gingivitis, as compared with plaque index is not reported. The microimaging technique was used to measure changes in the gingival thickness of the inter-dental tooth area. This area measured did not represent the clinical status of the tissue surrounding the tooth. The plaque index is reported. Visible Plaque Index; scoring: 0 = no plaque; 1 = visible plaque | Baseline to Day 14 | 
| Change From Day 14 Gingivitis at Day 28 as Measured by Non-invasive Microimaging and Plaque Index. | The predictive validity of a microimaging technique for assessing experimental gingivitis, as compared with plaque index is not reported. The microimaging technique was used to measure changes in the gingival thickness of the inter-dental tooth area. This area measured did not represent the clinical status of the tissue surrounding the tooth. The plaque index is reported. Visible Plaque Index; scoring: 0 = no plaque; 1 = visible plaque | Day 14 to Day 28 | 
| Change From Baseline Angiogenesis Chemokine Concentration at Day 28 | Assessment of the concentration of the angiogenesis chemokine angiopoietin-1 during experimental gingivitis. | Baseline to Day 28 |