Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Philips Oral Healthcare | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This research study has 2 aims. One aim is to see if saliva testing can show if a person has healthy gum tissue, gingivitis, or one of three degrees of periodontitis - mild, moderate, or severe. The second aim is to examine the effect of the Sonicare Elite/Flexcare toothbrush on periodontitis.
Randomized controlled trial to determine clinical and inflammatory benefits of Sonicare Flexcare tooth brushing following experimental induction of biofilm overgrowth in various periodontal conditions.
This research study has both a Diagnostic Aim and a Treatment Aim. Aim #1 is to examine the utility of candidate inflammatory biomarkers within saliva to discriminate between health, gingivitis, mild, moderate and severe periodontis; and to discriminate between active versus inactive states of periodontal disease to see if these basal levels can predict the clinical response to biofilm overgrowth among various periodontal conditions; Aim #2 is to extend the claim of the anti-inflammatory and anti-infective efficacy of the Sonicare/Elite-Flexcare as compared to manual brushing to include 4 levels of periodontal disease [BGI-G, P1, P2 and P3].
The devices used in this study are subject only to Class I (general controls) and considered exempt from the premarket notification procedures and not subject to section 510(k), 515, or 520(m,) of the FDC Act in order to be legally marketed. Thus, the study does not meet the definition of an Applicable Clinical Trial.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sonicare Elite-Flexcare | Active Comparator | Arm 1 participants will abstain from brushing and flossing teeth in selected sites which will typically be one maxillary and mandibular posterior sextant during a three week, no-hygiene phase via placement of acrylic stents. After the stent-induced biofilm overgrowth (SIBO) induction, the resolution phase of the study will involve a randomization that places half of the subjects on the Sonicare/Elite/Flexcare toothbrush. Thus, the resolution phase is a RCT designed to treat SIBO in subjects with varying levels of disease. Participants will reinstate normal full mouth oral hygiene and daily plaque control, exclusive of flossing, with dispensed dentifrice and toothbrush. Participants will be followed for four weeks during SIBO resolution. |
|
| Manual Toothbrush | Active Comparator | Arm 2 participants will abstain from brushing and flossing teeth in selected sites which will typically be one maxillary and mandibular posterior sextant during a three week, no-hygiene phase via placement of acrylic stents. After the stent-induced biofilm overgrowth (SIBO) induction, the resolution phase of the study will involve a randomization that places half of the subjects on the manual toothbrush. Thus, the resolution phase is a RCT designed to treat SIBO in subjects with varying levels of disease. Participants will reinstate normal full mouth oral hygiene and daily plaque control, exclusive of flossing, with dispensed dentifrice and toothbrush. Participants will be followed for four weeks during SIBO resolution. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sonicare/Elite-Flexcare Toothbrush | Other | Philips Oral Healthcare product - battery powered menchanic toothbrush with nylon bristles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in (inflammatory biomarkers?) among a range of periodontal disease groups after using Sonicare Elite/Flexcare versus manual toothbrush for four weeks. | Four weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Identification of salivary biomarkers that can distinguish between and among the 5 disease categories (health, gingivitis, and 3 levels of periodontal disease). | 4 weeks |
Not provided
Inclusion Criteria:
adult males or females between the ages of 18 and 75 years (inclusive).
able and willing to follow study procedures and instructions.
read, understood and signed an informed consent form.
present with at least 8 teeth in the functional dentition with a minimum of 3 adjacent teeth with interproximal papilla in each posterior sextant that will have the stent.
be in good general health.
present with one of the following five categories to be considered for enrollment
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Steven Offenbacher, DDS PhD MMSc | The University of North Carolina at Chapel Hill School of Dentistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of North Carolina at Chapel Hill School of Dentistry | Chapel Hill | North Carolina | 27599 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
| Manual Toothbrush | Other | traditional (non-mechanical) toothbrush with nylon bristles and plastic handle |
|
| ID | Term |
|---|---|
| D007249 | Inflammation |
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided