Back to resultsSalivary Inflammatory Biomarkers: Predictors & Comparative Effects of Sonicare/Elite-Flexcare in Stages of Perio Disease
Primary Purpose
Inflammation, Periodontitis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sonicare/Elite-Flexcare Toothbrush
Manual Toothbrush
Sponsored by
About this trial
This is an interventional other trial for Inflammation focused on measuring Inflammatory biomarkers, Periodontitis
Eligibility Criteria
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
- BGI health (all PD<3mm, BOP<10%)
- BGI-gingivitis (all PD≤3mm, BOP≥10%)
- BGI-P1 (1+ site with PD>3mm, BOP≤10%)
- BGI-P2 (1+ site with PD>3mm, BOP>10% but BOP≤50%)
- BGI-P3 (1+ site with PD>3mm, BOP>50%)
Exclusion Criteria:
- chronic disease with oral manifestations or active infectious diseases such as hepatitis, HIV or tuberculosis.
- gross oral pathology.
- treatment with antibiotics for any medical or dental condition within 1 month prior to the screening examination.
- chronic treatment (i.e., two weeks or more) with any medication known to affect periodontal status (e.g., phenytoin, calcium antagonists, cyclosporin, anticoagulants, non-steroidal anti-inflammatory drugs, high dose aspirin such as >100mg per day) within one month of the screening examination.
- ongoing medications initiated less than three months prior to enrollment (i.e., medications for chronic medical conditions must be initiated at least three months prior to enrollment).
- clinically significant organ disease including impaired renal function, and/or any bleeding disorder.
- severe unrestored caries, or any condition that is likely to require antibiotic treatment during the study, including the need for prophylactic antibiotic.
- use any tobacco products or who have used tobacco products within the previous six months of the screening examination.
- pregnant, or expect to become pregnant within the next three months and individuals nursing.
- dental appliances that will interfere with stent construction.
Sites / Locations
- The University of North Carolina at Chapel Hill School of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Sonicare Elite-Flexcare
Manual Toothbrush
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change from baseline in (inflammatory biomarkers?) among a range of periodontal disease groups after using Sonicare Elite/Flexcare versus manual toothbrush for four weeks.
Secondary Outcome Measures
Identification of salivary biomarkers that can distinguish between and among the 5 disease categories (health, gingivitis, and 3 levels of periodontal disease).
Full Information
NCT ID
NCT02187185
First Posted
July 8, 2014
Last Updated
August 28, 2018
Sponsor
University of North Carolina, Chapel Hill
Collaborators
Philips Oral Healthcare
1. Study Identification
Unique Protocol Identification Number
NCT02187185
Brief Title
Salivary Inflammatory Biomarkers: Predictors & Comparative Effects of Sonicare/Elite-Flexcare in Stages of Perio Disease
Official Title
Studies of Salivary Inflammatory Biomarkers During Biofilm Overgrowth: Confirmation of Predictors and Comparative Effects of Sonicare/Elite-Flexcare in Various Stages of Periodontal Disease
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
Philips Oral Healthcare
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation, Periodontitis
Keywords
Inflammatory biomarkers, Periodontitis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
175 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sonicare Elite-Flexcare
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Manual Toothbrush
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Sonicare/Elite-Flexcare Toothbrush
Intervention Description
Philips Oral Healthcare product - battery powered menchanic toothbrush with nylon bristles
Intervention Type
Other
Intervention Name(s)
Manual Toothbrush
Intervention Description
traditional (non-mechanical) toothbrush with nylon bristles and plastic handle
Primary Outcome Measure Information:
Title
Change from baseline in (inflammatory biomarkers?) among a range of periodontal disease groups after using Sonicare Elite/Flexcare versus manual toothbrush for four weeks.
Time Frame
Four weeks
Secondary Outcome Measure Information:
Title
Identification of salivary biomarkers that can distinguish between and among the 5 disease categories (health, gingivitis, and 3 levels of periodontal disease).
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
BGI health (all PD<3mm, BOP<10%)
BGI-gingivitis (all PD≤3mm, BOP≥10%)
BGI-P1 (1+ site with PD>3mm, BOP≤10%)
BGI-P2 (1+ site with PD>3mm, BOP>10% but BOP≤50%)
BGI-P3 (1+ site with PD>3mm, BOP>50%)
Exclusion Criteria:
chronic disease with oral manifestations or active infectious diseases such as hepatitis, HIV or tuberculosis.
gross oral pathology.
treatment with antibiotics for any medical or dental condition within 1 month prior to the screening examination.
chronic treatment (i.e., two weeks or more) with any medication known to affect periodontal status (e.g., phenytoin, calcium antagonists, cyclosporin, anticoagulants, non-steroidal anti-inflammatory drugs, high dose aspirin such as >100mg per day) within one month of the screening examination.
ongoing medications initiated less than three months prior to enrollment (i.e., medications for chronic medical conditions must be initiated at least three months prior to enrollment).
clinically significant organ disease including impaired renal function, and/or any bleeding disorder.
severe unrestored caries, or any condition that is likely to require antibiotic treatment during the study, including the need for prophylactic antibiotic.
use any tobacco products or who have used tobacco products within the previous six months of the screening examination.
pregnant, or expect to become pregnant within the next three months and individuals nursing.
dental appliances that will interfere with stent construction.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Offenbacher, DDS PhD MMSc
Organizational Affiliation
The University of North Carolina at Chapel Hill School of Dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of North Carolina at Chapel Hill School of Dentistry
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
12. IPD Sharing Statement
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Salivary Inflammatory Biomarkers: Predictors & Comparative Effects of Sonicare/Elite-Flexcare in Stages of Perio Disease
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