Clinical trial NCT00762528: Compare Anti-inflammatory Dentifrices
Official title: Compare Anti-inflammatory Dentifrices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gingivitis
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
First posted: 2008-09-30
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Plaque induced gingivitis


Eligibility criteria: 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 read, understood and signed an informed consent form
* 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 mm and at least 30% of sites bleeding to gentle probing

Exclusion Criteria:

* Subjects who have chronically used (i.e., 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 mm 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 or lactating, or female subjects who are of childbearing potential and who report not using hormonal or barrier methods of birth control (oral or parenteral contraceptives, diaphragm plus spermicide, condoms)
* 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.

Primary outcomes:
measure: Gingival Index (GI)
timeFrame: 29 days
measure: Prostaglandin E2 (PGE2)
timeFrame: 29 days
measure: Interleukin - 1 Beta (IL-ß)
timeFrame: 29 days
measure: Interleukin-6 (IL-6)
timeFrame: 29 days
measure: Nuclear Factor Kappa B Ligand (RANK-L)
timeFrame: 29 days
measure: 8-iso-prostaglandinF2α (8-iso-PGF2α)
timeFrame: 29 days
Secondary outcomes:
measure: Dental Plaque Index (PI)
timeFrame: 29 days
measure: Bleeding on Probing (BOP)
timeFrame: 29 days
Other outcomes:
Locations:
city: Greenville
country: United States
facility: East Carolina University, Brody School of Medicine
state: North Carolina
Study officials:
name: Sara G Grossi, DDS
role: PRINCIPAL_INVESTIGATOR
References: