Skip to main content
TrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor about whether a trial is right for you.
RECRUITINGPhase 3INTERVENTIONAL

Efficacy of a Stannous Fluoride Toothpaste, Cetylpyridinium Chloride Mouthwash, and Battery Toothbrush Regimen in Reducing Established Dental Plaque and Gingivitis.

A 12-Week Clinical Study to Evaluate the Efficacy of a Stannous Fluoride Toothpaste, Cetylpyridinium Chloride Mouthwash, and Battery Toothbrush Regimen in Reducing Established Dental Plaque and Gingivitis.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

To evaluate the efficacy of a stannous fluoride toothpaste, Cetylpyridinium Chloride Mouthwash, and Battery Toothbrush Regimen in Reducing Established Dental Plaque and Gingivitis.

Who May Be Eligible (Plain English)

Who May Qualify: - Signed willing to sign a consent form Form. - Male and female subjects aged 18-70 years, inclusive. - Availability for the twelve-week duration of the clinical research study. - Good general health based on the opinion of the study investigator - Minimum of 20 permanent natural teeth (excluding third molars). - Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index. - Initial mean plaque index of at least 0.6 as determined by Rustogi Modification of the Navy plaque index. Who Should NOT Join This Trial: - Presence of orthodontic appliances; - Presence of partial removable dentures; - Oral pathology, chronic disease or tumor(s) of the soft or hard tissues of the oral cavity; 4. Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone); - Five or more carious lesions requiring immediate restorative treatment; - Use of anticonvulsants, sedatives, tranquilizers, anti-inflammatory or daily analgesics within one month prior to the start of the study or scheduled to start such intake during the course of the study; - Use of antibiotics any time during the one-month period prior to entry into the study; - Ongoing use of medications known to affect the gingival tissues (i.e. calcium channel blockers, phenytoin, cyclosporine) and/or on any prescription medicines that might interfere with the study outcome; - Participation in any other clinical study; - Self-reported pregnancy and/or breastfeeding; - Dental prophylaxis within the past three weeks prior to baseline examinations; - Current allergies and/or history of allergic reactions to oral care products, personal care consumer products, or any of their ingredients; - An existing medical condition that prohibits eating and/or drinking for periods up to 4 hours; - Current smokers and/or a history of alcohol or drug abuse Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Signed Informed Consent Form. * Male and female subjects aged 18-70 years, inclusive. * Availability for the twelve-week duration of the clinical research study. * Good general health based on the opinion of the study investigator * Minimum of 20 permanent natural teeth (excluding third molars). * Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index. * Initial mean plaque index of at least 0.6 as determined by Rustogi Modification of the Navy plaque index. Exclusion Criteria: * Presence of orthodontic appliances; * Presence of partial removable dentures; * Oral pathology, chronic disease or tumor(s) of the soft or hard tissues of the oral cavity; 4. Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone); * Five or more carious lesions requiring immediate restorative treatment; * Use of anticonvulsants, sedatives, tranquilizers, anti-inflammatory or daily analgesics within one month prior to the start of the study or scheduled to start such intake during the course of the study; * Use of antibiotics any time during the one-month period prior to entry into the study; * Ongoing use of medications known to affect the gingival tissues (i.e. calcium channel blockers, phenytoin, cyclosporine) and/or on any prescription medicines that might interfere with the study outcome; * Participation in any other clinical study; * Self-reported pregnancy and/or breastfeeding; * Dental prophylaxis within the past three weeks prior to baseline examinations; * Current allergies and/or history of allergic reactions to oral care products, personal care consumer products, or any of their ingredients; * An existing medical condition that prohibits eating and/or drinking for periods up to 4 hours; * Current smokers and/or a history of alcohol or drug abuse

Treatments Being Tested

DRUG

0.454%Stannous fluoride toothpaste

toothpaste

DRUG

0.075% Cetylpyridinium Chloride (CPC) and 0.28% zinc lactatmouthwashe

mouthwash

DRUG

0.76% Sodium Monofluorophosphate (Na MFP) toothpaste

toothpaste

DRUG

0.022% Sodium Fluoride mouthwash

mouthwash

Locations (1)

Consumer Research Consulting, LLC
Melbourne, Florida, United States