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

NCT02187185 | Completed

• 1 other identifier: 09-0627
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammation; Periodontitis

Keywords

Inflammatory biomarkers; Periodontitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Identification of salivary biomarkers that can distinguish between and among the 5 disease categories (health, gingivitis, and 3 levels of periodontal disease).

  4 weeks

Study Arms (2)

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.

Other: Sonicare/Elite-Flexcare Toothbrush

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.

Other: Manual Toothbrush

Interventions

Sonicare/Elite-Flexcare Toothbrush OTHER

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

Sonicare Elite-Flexcare

Manual Toothbrush OTHER

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

Manual Toothbrush

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Philips Oral Healthcare: collaborator

Study Sites (1)

The University of North Carolina at Chapel Hill School of Dentistry

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Inflammation; Periodontitis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Steven Offenbacher, DDS PhD MMSc

  The University of North Carolina at Chapel Hill School of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2014
• First Posted: July 10, 2014
• Study Start: April 1, 2009
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: August 31, 2018

Record last verified: 2017-01

Locations

US (1)