Salivary Inflammatory Biomarkers: Predictors & Comparative Effects of Sonicare/Elite-Flexcare in Stages of Perio Disease

Studies of Salivary Inflammatory Biomarkers During Biofilm Overgrowth: Confirmation of Predictors and Comparative Effects of Sonicare/Elite-Flexcare in Various Stages of Periodontal Disease

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.

Study Overview

• Status: Completed
• Conditions: Inflammation; Periodontitis
• Intervention / Treatment: Other: Sonicare/Elite-Flexcare Toothbrush; Other: Manual Toothbrush

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.

• Study Type: Interventional
• Enrollment (Actual): 175
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • The University of North Carolina at Chapel Hill School of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. adult males or females between the ages of 18 and 75 years (inclusive).
2. able and willing to follow study procedures and instructions.
3. read, understood and signed an informed consent form.
4. 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.
5. be in good general health.

6. 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:

1. chronic disease with oral manifestations or active infectious diseases such as hepatitis, HIV or tuberculosis.
2. gross oral pathology.
3. treatment with antibiotics for any medical or dental condition within 1 month prior to the screening examination.
4. 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.
5. 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).
6. clinically significant organ disease including impaired renal function, and/or any bleeding disorder.
7. severe unrestored caries, or any condition that is likely to require antibiotic treatment during the study, including the need for prophylactic antibiotic.
8. use any tobacco products or who have used tobacco products within the previous six months of the screening examination.
9. pregnant, or expect to become pregnant within the next three months and individuals nursing.
10. dental appliances that will interfere with stent construction.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sonicare Elite-Flexcare; 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.	Other: Sonicare/Elite-Flexcare Toothbrush; Philips Oral Healthcare product - battery powered menchanic toothbrush with nylon bristles
Active Comparator: Manual Toothbrush; 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.	Other: Manual Toothbrush; traditional (non-mechanical) toothbrush with nylon bristles and plastic handle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Philips Oral Healthcare
• Investigators: Principal Investigator: Steven Offenbacher, DDS PhD MMSc, The University of North Carolina at Chapel Hill School of Dentistry

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: July 8, 2014
• First Submitted That Met QC Criteria: July 8, 2014
• First Posted (Estimate): July 10, 2014

Study Record Updates

• Last Update Posted (Actual): August 31, 2018
• Last Update Submitted That Met QC Criteria: August 28, 2018
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Periodontitis; Inflammatory biomarkers
• Additional Relevant MeSH Terms: Pathologic Processes; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Inflammation
• Other Study ID Numbers: 09-0627