Plaque Induced Gingivitis
Conditions
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).
Interventions
DEVICEPlaque 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.
DEVICEOral 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.
Sponsors
Colgate Palmolive
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Split-mouth
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Gingivitis at Day 14 as Measured by Non-invasive Microimaging and Gingival Index. | Baseline to Day 14 | 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 |
| Change From Day 14 Gingivitis at Day 28 as Measured by Non-invasive Microimaging and Gingival Index. | Day 14 to Day 28 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Gingivitis at Day 14 as Measured by Non-invasive Microimaging and Plaque Index. | Baseline to Day 14 | 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 |
| Change From Day 14 Gingivitis at Day 28 as Measured by Non-invasive Microimaging and Plaque Index. | Day 14 to Day 28 | 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 |
| Change From Baseline Angiogenesis Chemokine Concentration at Day 28 | Baseline to Day 28 | Assessment of the concentration of the angiogenesis chemokine angiopoietin-1 during experimental gingivitis. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 13 |
| 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. | 13 |
| 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. | 13 |
| 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. | 13 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Hygiene Phase of 2 Weeks | Not eligible at Baseline (start of gingivitis induction phase) | 1 | 1 |
| Hygiene Phase of 2 Weeks | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | Oral Hygiene Maintenance | Total | Plaque Induced Gingivitis |
|---|---|---|---|
| Age, Continuous | 23.3 years | 23.3 years | 23.3 years |
| Angiogenesis chemokine - angiopoietin-1 | 165053.91 picograms/milliliter STANDARD_DEVIATION 408314.93 | 153133.62 picograms/milliliter STANDARD_DEVIATION 367653.68 | 141213.37 picograms/milliliter STANDARD_DEVIATION 338487.23 |
| Gingival Index | 0.055 units on a scale STANDARD_DEVIATION 0.3 | 0.077 units on a scale STANDARD_DEVIATION 0.12 | 0.085 units on a scale STANDARD_DEVIATION 0.3 |
| Race/Ethnicity, Customized American Indian or Alaska Native, Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native, Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian, Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian, Not Hispanic or Latino | 8 Participants | 8 Participants | 8 Participants |
| Race/Ethnicity, Customized Black or African American, Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American, Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized More than one race, Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized More than one race, Not Hispanic or Latino | 2 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander, Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander, Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Unknown or Not Reported, Hispanic or Latino | 1 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Unknown or Not Reported, Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White, Hispanic or Latino | 1 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White, Not Hispanic or Latino | 1 Participants | 1 Participants | 1 Participants |
| Sex/Gender, Customized Female | 7 participants | 7 participants | 7 participants |
| Sex/Gender, Customized Male | 6 participants | 6 participants | 6 participants |
| Visible Plaque Index | 0.05 units on a scale STANDARD_DEVIATION 0.2 | 0.067 units on a scale STANDARD_DEVIATION 0.12 | 0.078 units on a scale STANDARD_DEVIATION 0.3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 13 | 0 / 13 | 0 / 13 |
| other Total, other adverse events | 0 / 13 | 0 / 13 | 4 / 13 | 3 / 13 |
| serious Total, serious adverse events | 0 / 13 | 0 / 13 | 0 / 13 | 0 / 13 |
Outcome results
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
Time frame: Baseline to Day 14
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Plaque Induced Gingivitis | Change From Baseline Gingivitis at Day 14 as Measured by Non-invasive Microimaging and Gingival Index. | 0.6 units on a scale | Standard Deviation 1.2 |
| Oral Hygiene Maintenance | Change From Baseline Gingivitis at Day 14 as Measured by Non-invasive Microimaging and Gingival Index. | 0.15 units on a scale | Standard Deviation 0.3 |
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
Time frame: Day 14 to Day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Plaque Induced Gingivitis | Change From Day 14 Gingivitis at Day 28 as Measured by Non-invasive Microimaging and Gingival Index. | 0.08 units on a scale | Standard Deviation 0.4 |
| Oral Hygiene Maintenance | Change From Day 14 Gingivitis at Day 28 as Measured by Non-invasive Microimaging and Gingival Index. | 0.08 units on a scale | Standard Deviation 0.2 |
Secondary
Change From Baseline Angiogenesis Chemokine Concentration at Day 28
Assessment of the concentration of the angiogenesis chemokine angiopoietin-1 during experimental gingivitis.
Time frame: Baseline to Day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Plaque Induced Gingivitis | Change From Baseline Angiogenesis Chemokine Concentration at Day 28 | 137825.56 picograms/milliliter | Standard Deviation 339893.64 |
| Oral Hygiene Maintenance | Change From Baseline Angiogenesis Chemokine Concentration at Day 28 | 164411.80 picograms/milliliter | Standard Deviation 408590.49 |
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
Time frame: Baseline to Day 14
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Plaque Induced Gingivitis | Change From Baseline Gingivitis at Day 14 as Measured by Non-invasive Microimaging and Plaque Index. | 0.84 units on a scale | Standard Deviation 1.4 |
| Oral Hygiene Maintenance | Change From Baseline Gingivitis at Day 14 as Measured by Non-invasive Microimaging and Plaque Index. | 0.17 units on a scale | Standard Deviation 0.24 |
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
Time frame: Day 14 to Day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Plaque Induced Gingivitis | Change From Day 14 Gingivitis at Day 28 as Measured by Non-invasive Microimaging and Plaque Index. | 0.11 units on a scale | Standard Deviation 0.18 |
| Oral Hygiene Maintenance | Change From Day 14 Gingivitis at Day 28 as Measured by Non-invasive Microimaging and Plaque Index. | 0.105 units on a scale | Standard Deviation 0.5 |