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

Completed · Not applicable

Conditions studied: Inflammation, Periodontitis

In brief

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.

Key facts

Study ID

NCT02187185

Run by

University of North Carolina, Chapel Hill

People needed

175

Starts

2009-04-01

Expected to finish

2012-03-01

Last updated by the study team

2018-08-31

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

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

Full record on ClinicalTrials.gov

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