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

NCT ID: NCT02187185

Last Updated: 2018-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 175 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2012-03-31

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.

Conditions

Inflammation; Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Sonicare/Elite-Flexcare Toothbrush

Intervention Type: OTHER

Philips Oral Healthcare product - battery powered menchanic toothbrush with nylon bristles

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.

Group Type: ACTIVE_COMPARATOR

Manual Toothbrush

Intervention Type: OTHER

traditional (non-mechanical) toothbrush with nylon bristles and plastic handle

Interventions

Sonicare/Elite-Flexcare Toothbrush

Philips Oral Healthcare product - battery powered menchanic toothbrush with nylon bristles

Intervention Type: OTHER

Manual Toothbrush

traditional (non-mechanical) toothbrush with nylon bristles and plastic handle

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Philips Oral Healthcare

INDUSTRY

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven Offenbacher, DDS PhD MMSc

Role: PRINCIPAL_INVESTIGATOR

The University of North Carolina at Chapel Hill School of Dentistry

Locations

The University of North Carolina at Chapel Hill School of Dentistry

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

09-0627

Identifier Type: -

Identifier Source: org_study_id