Status:
COMPLETED
Salivary Inflammatory Biomarkers: Predictors & Comparative Effects of Sonicare/Elite-Flexcare in Stages of Perio Disease
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Philips Oral Healthcare
Conditions:
Inflammation
Periodontitis
Eligibility:
All Genders
18-75 years
Phase:
NA
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 s...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
175 Patients enrolled
Trial Details
Trial ID
NCT02187185
Start Date
April 1 2009
End Date
March 1 2012
Last Update
August 31 2018
Active Locations (1)
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1
The University of North Carolina at Chapel Hill School of Dentistry
Chapel Hill, North Carolina, United States, 27599