Dental Gingivitis, Dental Plaque
Conditions
Brief summary
This study assessed the efficacy of an oral hygiene regimen relative to a standard marketed toothpaste and manual toothbrush.
Interventions
DRUGChina Crest® Pro-health 7 Complete Toothpaste
Crest® pro-health manual toothbrush Crest® pro-health gum protection rinse
DRUGChina Crest® Cavity Protection Toothpaste
Crest® meliliangje manual toothbrush
Sponsors
Procter and Gamble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* give written informed consent prior to their participation; * be 18 to 65 years of age at the time of enrollment; * agree not to participate in any other oral/dental product studies; * agree to delay any elective dentistry (including a dental prophylaxis); * agree to refrain from the use of any non-study oral care products (including floss and mouthrinse) during the course of the study; * agree to return for the scheduled visits and follow study procedures; * be in good general health as determined by the investigator/designee based on a review of the health history/update for participation in the study; * have more than 10 bleeding sites at visits 1-3 * Consistency of bleeding site number at baseline may be considered; * have a minimum of 18 natural teeth with facial and lingual scorable surfaces; and * refrain from performing any oral hygiene or consuming anything by mouth (except a small amount of water) at least 4 hours prior to their appointment.
Exclusion criteria
* teeth that are grossly carious, fully crowned, extensively restored and have heavy dental calculus * antibiotic, anti-inflammatory or anti-coagulant therapy within two weeks of to the baseline exam * medical conditions that the investigator considers significant and that may compromise the evaluation of study results * currently participating in any other clinical trial * participated in a clinical trial for plaque/gingivitis within the previous 30 days * pregnant or lactating * orthodontic appliances or removable partial dentures * soft or hard tissue tumor of the oral cavity * advanced periodontal disease * history of hepatitis, diabetes, or other communicable diseases * history of rheumatic fever, heart murmur, mitral valve prolapse or other conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures * history of significant adverse effects following the use of oral hygiene products such as toothpaste * oral pathoses that could interfere with compliance and/or examinations or that need treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gingivitis | Day 0 | Gingivitis was assessed according to the Gingival Bleeding Index |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plaque Examination | Day 0 | The Modified Turesky Plaque Index was used to examine plaque. |
Outcome results
None listed