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| Name | Class |
|---|---|
| Colgate Palmolive | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plaque induced gingivitis | Experimental | 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. |
|
| Oral hygiene maintenance | Active Comparator | Non-invasive microimaging (OTC device) of gingival tissue where oral hygiene (tooth brushing with fluoride toothpaste and flossing twice daily) is maintained. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plaque induced gingivitis | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
• Medical condition which requires premedication prior to dental treatments/visits
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| Name | Affiliation | Role |
|---|---|---|
| Richard P Darveau, MS, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington School of Dentistry | Seattle | Washington | 98195 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Plaque Induced Gingivitis | Plaque induced gingivitis resulting from a cessation of oral hygiene in maxillary sextant right (teeth #5 to #8) or left (#9 to #12) using a stent-induced biofilm overgrowth (SIBO) model. |
| FG001 | Oral Hygiene Maintenance | Oral hygiene (tooth brushing with fluoride toothpaste and flossing twice daily) is maintained in a maxillary right (teeth #5 to #8) or left (#9 to #12) sextant. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hygiene Phase of 2 Weeks |
|
| |||||||||||||||||||||
| Gingivitis Induction Phase of 2 Weeks |
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| Resolution Phase of 2 Weeks |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Plaque Induced Gingivitis | Plaque induced gingivitis resulting from a cessation of oral hygiene in a maxillary right (teeth #5 to #8) or left (#9 to #12) sextant using a stent-induced biofilm overgrowth model. |
| BG001 | Oral Hygiene Maintenance |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Deviation | units on a scale | Baseline to Day 14 |
|
6 weeks
Participants were questioned at each visit about adverse events since the previous visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Plaque Induced Gingivitis | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| rhinorrhea | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Diane Daubert | University of Washington | 206-685-3766 | ddaubert@uw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 18, 2018 | Nov 24, 2020 | Prot_SAP_000.pdf |
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Split-mouth
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|
|
| Oral hygiene maintenance | Device | Non-invasive microimaging (OTC device) of gingival tissue where oral hygiene has been maintained by tooth brushing with fluoride toothpaste and flossing twice daily. |
|
| 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 |
| NOT COMPLETED |
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| NOT COMPLETED |
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Oral hygiene (tooth brushing with fluoride toothpaste and flossing twice daily) is maintained in a maxillary right (teeth #5 to #8) or left (#9 to #12) sextant. |
| BG002 | Total | Total of all reporting groups |
| L(left) and R(right) Maxillary sextant |
|
| years |
| Participants |
|
| Sex/Gender, Customized | Number | participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants | Participants |
|
| Gingival Index | Loe and Silness Gingival Index (GI); scale: 0 = normal gingiva, 1 = mild inflammation, 2 = moderate inflammation, 3 = severe inflammation | Mean | Standard Deviation | units on a scale | Participants |
|
| Visible Plaque Index | Scoring: 0 = no plaque; 1 = visible plaque | Mean | Standard Deviation | units on a scale | Participants |
|
| Angiogenesis chemokine - angiopoietin-1 | Mean | Standard Deviation | picograms/milliliter | Participants |
|
| OG001 | Oral Hygiene Maintenance | Non-invasive microimaging (OTC device) of gingival tissue where oral hygiene (tooth brushing with fluoride toothpaste and flossing twice daily) is maintained. 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. |
|
|
| Primary | 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 | Posted | Mean | Standard Deviation | units on a scale | Day 14 to Day 28 |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | units on a scale | Baseline to Day 14 |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | units on a scale | Day 14 to Day 28 |
|
|
|
| Secondary | Change From Baseline Angiogenesis Chemokine Concentration at Day 28 | Assessment of the concentration of the angiogenesis chemokine angiopoietin-1 during experimental gingivitis. | Posted | Mean | Standard Deviation | picograms/milliliter | Baseline to Day 28 |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Oral Hygiene Maintenance | Non-invasive microimaging (OTC device) of gingival tissue where oral hygiene (tooth brushing with fluoride toothpaste and flossing twice daily) is maintained. | 0 | 13 | 0 | 13 | 0 | 13 |
| EG002 | Hygiene Phase | Adverse Events that occurred during the Hygiene Phase of 2 weeks (the period between enrollment and the start of the Gingivitis Induction Phase of 2 weeks). | 0 | 13 | 0 | 13 | 4 | 13 |
| EG003 | Systemic Adverse Events | Adverse Events that occurred during the Gingivitis Induction Phase of 2 weeks and the Resolution Phase 2 weeks but are not specifically attributable to either the Plaque Induced Gingivitis intervention or the Oral Hygiene Maintenance intervention as the two interventions occurred simultaneously in each participant. | 0 | 13 | 0 | 13 | 3 | 13 |
| menstrual cramps | Reproductive system and breast disorders | Systematic Assessment |
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| cold | Infections and infestations | Systematic Assessment |
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| ulcerated interdental papilla #14/15 | Injury, poisoning and procedural complications | Systematic Assessment |
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| bruised achilles tendon | Injury, poisoning and procedural complications | Systematic Assessment |
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| abraded palatal tissue left posterior | Gastrointestinal disorders | Systematic Assessment |
|
| tender maxillary left posterior buccal gingiva | Injury, poisoning and procedural complications | Systematic Assessment |
|
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