Evaluate Inflammation Caused by Gingivitis in Adults



Status:Completed
Conditions:Dental
Therapuetic Areas:Dental / Maxillofacial Surgery
Healthy:No
Age Range:18 - 60
Updated:4/21/2016
Start Date:January 2007
End Date:August 2008

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The purpose of this study is to compare the anti-inflammatory efficacy of a dentifrice


Inclusion Criteria:

- Subjects must be adult males or females 18 to 60 years old

- Subjects must be able and willing to follow study procedures and instructions

- Subjects must have generalized, moderate plaque-associated gingivitis as determined
by the Investigator or designee during the screening examination

- Subjects must present with at least 20 teeth in the functional dentition, excluding
third molars

- Each subject must have at least four teeth with probing depths of 4-5 millimeters and
at least 30% of sites bleeding to gentle probing

Exclusion Criteria:

- Subjects who have chronically used (two weeks or more) Total (Triclosan/Copolymer)
dentifrice within 6 months prior to enrollment

- Subjects with gross oral pathology, including widespread caries or chronic neglect,
extensive restoration, pre-existing gross plaque and calculus, or soft or hard tissue
tumor of the oral cavity

- Subjects with periodontitis as indicated by periodontal pocketing 6 millimeters at
screening

- Subjects with a history of early onset periodontitis or acute necrotizing ulcerative
gingivitis

- Subjects with concomitant endodontic or periodontal therapy other than prophylaxis
within 6 months prior to enrollment

- Subjects with orthodontic appliances or removable partial dentures

- Subjects chronically treated (two weeks or more) with any medication known to affect
inflammation or periodontal status or (aspirin, nonsteroidal anti-inflammatory drugs,
steroids, statins, phenytoin, calcium antagonists, cyclosporin and coumadin) within
one month of the screening examination. All other medications for chronic medical
conditions should be initiated at least three months prior to enrollment

- Subjects who currently smoke or who report using tobacco products within one year of
screening.

- Subjects who have been treated with antibiotics for medical or dental reasons within
3 months prior to enrollment

- Subjects having clinically significant or unstable organic disease; subjects having
compromised healing potential such as those with diabetes mellitus or connective
tissue disorders; subjects having heart murmurs, histories of rheumatic fever,
valvular disease or prosthetic joint replacement necessitating antibiotic prophylaxis

- Female subjects who report being pregnant

- Subjects who use hormonal contraceptives must have started the method 30 days prior
to the screening examination.

- Subjects with active infectious diseases such as hepatitis, human immunodeficiency
virus or Tuberculosis

- Subjects diagnosed with human immunodeficiency virus (HIV) or subjects that are
immunocompromised as determined by the Investigator

- Medical condition which precludes not eating/drinking for approximately 8 hours.
We found this trial at
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Chapel Hill, North Carolina 27599
(919) 962-2211
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