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| ID | Type | Description | Link |
|---|---|---|---|
| 10438 | Other Identifier | TUSDM IRB |
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Terminated by financier due to low accrual & high number of protocol deviations.
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| Name | Class |
|---|---|
| Philips Oral Healthcare | INDUSTRY |
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In the current study, Sonicare AirFloss (AF) will be used in combination with a Manual Toothbrush (MTB) in a population of manual toothbrush users who are irregular flossers and who exhibit signs of moderate gingivitis. The alternate test arm will be allocated to a No Intervention group and will be given no test products or instruction other than to change none of their typical at home oral hygiene habits.
The aim of this study is to investigate how an AF and MTB oral hygiene intervention will affect a population of irregular flossers using the residual protein concentration method as an interproximal plaque efficacy assessment. Gingivitis reduction will be assessed using the Modified Gingival Index (MGI) and Gingival Bleeding Index (GBI) indices
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Airflosser | Experimental | Use of Airflosser |
|
| Manual Floss | Active Comparator | Normal Routine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Airflosser | Device | Use of Philips Airflosser |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The Effect of Sonicare AirFloss + MTB Treatment Versus the Control Group | The primary objective of the study is to compare the effect of Sonicare AirFloss + MTB treatment versus the Control Group on gingival inflammation (as measure by number of bleeding sites, and reduction in MGI) after four weeks of use. | Four Months |
| Measure | Description | Time Frame |
|---|---|---|
| Gingival Inflammation | Evaluate the effect of the Sonicare AirFloss + MTB treatment on gingival inflammation as measured after 2 and 4 weeks versus baseline. | 4 weeks |
| Number of Bleeding Sites |
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4.1 Inclusion Criteria
Subjects accepted into the study must meet the following requirements:
4.2 Exclusion Criteria Subjects will be excluded from the study if they;
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| Name | Affiliation | Role |
|---|---|---|
| Gerard Kugel, DMD, MS, PhD | TUSDM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tufts University School of Dental Medicine | Boston | Massachusetts | 02111 | United States |
Of the 257 subjects who signed consent forms, 140 (54.5% were classified as screen failures). 1 additional subject declined to participate after screening but before randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Enrolled Subjects | Airflosser & Manual Floss |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Data cannot be provided for each arm separately, but only in aggregate
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| ID | Title | Description |
|---|---|---|
| BG000 | All Randomized Subjects | The study was terminated early, data were not analyzed and the plaque samples were destroyed. Data cannot be provided for each arm separately, but only in aggregate. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | The Effect of Sonicare AirFloss + MTB Treatment Versus the Control Group | The primary objective of the study is to compare the effect of Sonicare AirFloss + MTB treatment versus the Control Group on gingival inflammation (as measure by number of bleeding sites, and reduction in MGI) after four weeks of use. | Terminated by financier due to low accrual & high number of protocol deviations. | Posted | Four Months |
|
|
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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 | All Randomized Subjects | Summary of AEs for All Randomized Subjects |
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Terminated by sponsor due to:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marcia Delaurenti, Clinical Project Manager | Philips Oral Healthcare, Inc | 425-908-1212 | marcia.delaurenti@philips.com |
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| ID | Term |
|---|---|
| D005891 | Gingivitis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
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| Manual Floss | Device | Active Comparator |
|
Compare the number of bleeding sites in Modified Gingival Index following 2 weeks of use of the Sonicare AirFloss + Manual Toothbrush versus the Control Group.
| 2 Weeks |
| Plaque | Compare plaque as measured by the reduction and percent reduction in Residual Protein Concentration (RPC) following 2 and 4 weeks of use of the Sonicare AirFloss + MTB and Control Group. | 4 Weeks |
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | Assess the safety of the Sonicare AirFloss + MTB treatment. | 4 Months |
| Percentage of Bleeding Sites | Compare the percentage of bleeding sites in Modified Gingival Index following 2 weeks of use of the Sonicare AirFloss + Manual Toothbrush versus the Control Group. | 2 Weeks |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Number of Missing Teeth | Mean | Standard Deviation | missing teeth |
|
| Average Modified Gingival Index Score | The Modified Gingival Index (MGI) scale 0 = absence of inflammation;
| Mean | Standard Deviation | units on a scale |
|
| Number of Bleeding Sites | Mean | Standard Deviation | number of sites |
|
| Percent of Site Bleeding | Mean | Standard Deviation | percent of sites |
|
|
| Secondary | Gingival Inflammation | Evaluate the effect of the Sonicare AirFloss + MTB treatment on gingival inflammation as measured after 2 and 4 weeks versus baseline. | The study was terminated early, data were not analyzed and the plaque samples were destroyed. | Posted | 4 weeks |
|
|
| Secondary | Number of Bleeding Sites | Compare the number of bleeding sites in Modified Gingival Index following 2 weeks of use of the Sonicare AirFloss + Manual Toothbrush versus the Control Group. | The study was terminated early, data were not analyzed and the plaque samples were destroyed. | Posted | 2 Weeks |
|
|
| Secondary | Plaque | Compare plaque as measured by the reduction and percent reduction in Residual Protein Concentration (RPC) following 2 and 4 weeks of use of the Sonicare AirFloss + MTB and Control Group. | The study was terminated early, data were not analyzed and the plaque samples were destroyed. | Posted | 4 Weeks |
|
|
| Secondary | Number of Participants With Adverse Events as a Measure of Safety and Tolerability | Assess the safety of the Sonicare AirFloss + MTB treatment. | The study was terminated early, data were not analyzed and the plaque samples were destroyed. | Posted | 4 Months |
|
|
| Secondary | Percentage of Bleeding Sites | Compare the percentage of bleeding sites in Modified Gingival Index following 2 weeks of use of the Sonicare AirFloss + Manual Toothbrush versus the Control Group. | The study was terminated early, data were not analyzed and the plaque samples were destroyed. | Posted | 2 Weeks |
|
|
| 0 |
| 116 |
| 0 |
| 116 |
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| D009057 |
| Stomatognathic Diseases |