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.
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