| Eligibility |
Inclusion Criteria:
1. Be between the ages of 18 and 65, ambulatory and in good general health as determined
by the Study Examiner, based upon clinical observation and the Medical/Dental History;
2. Be able to understand and sign the Informed Consent, complete a Medical History form,
understand and comply with all study directions, and be available for all exam
periods;
3. Present with adequate oral hygiene (i.e. brush teeth daily and exhibit no signs of
oral neglect) and continue to meet the inclusion criteria and not fall into the
categories of exclusion during the period of the study;
4. Have at least 16 natural teeth in a good state of repair and at least 8 of the 12
anterior teeth free from full crowns or extensive restorations;
5. Have a mean Macpherson Modified Lobene Stain Index (MLSI) score of = 1.5 on the labial
surfaces of at least 8 of 12 anterior teeth;
6. Have had a dental prophylaxis within the past 18 months, but not within the past 3
months;
7. Agree to refrain from using all oral care products (other dentifrices and
toothbrushes, dental floss, and mouth rinses) other than their assigned products for
the duration of the study.
8. Agree to comply with the conditions and schedule of the study; and
9. Approximately 50% of study participants will be regular power brush users, with the
remaining 50% of study participants regular manual brush users.
Exclusion Criteria:
1. Have a history of serious medical conditions or transmittable diseases including but
not limited to COVID-19, active hepatitis, heart irregularities, conditions requiring
pre-medication for dental procedures, rheumatic heart disease, untreated diabetes
mellitus, cirrhosis, leukemia, phenylketonuria, renal disease, sarcoidosis,
tuberculosis, bleeding disorder, vascular disease, AIDS, history of drug allergies or
idiosyncrasies, or any other medical condition that may preclude successful
participation in the trial, at the discretion of the Study Examiner;
2. Have had prior significant adverse effects following use of oral hygiene products;
3. Have the presence of orthodontic bands, retainers, fixed appliances, large
restorations, or removable partial dentures, which may interfere with clinical
assessments of the evaluable teeth;
4. Show evidence of neglected dental health in need of prompt professional attention
(i.e. gross calculus deposits or rampant caries), significant oral soft tissue
pathology, systemically-related gingival enlargement, generalized recession, tissue
damage due to ill-fitting appliances or restorations or extreme crowding or
overlapping of teeth;
5. Have moderate/advanced periodontitis (ADA Class III or IV), e.g. more than two teeth
with periodontal pockets >4 mm as evidenced by purulent exudate, tooth mobility, and
other signs indicating that the integrity of the data collected might be compromised;
6. Have medication therapy that is current and ongoing or within the past 4 weeks, which
might interfere with the outcome of the study by affecting oral tissue condition,
salivation, or stain formation (particularly chronic long-term medication therapy);
7. Are nursing (breast-feeding) or pregnant;
8. Present at baseline with any reported sensory reactions, observed gum irritation or
any condition that would interfere with subsequent clinical assessments, or subjects
with a history of allergy to oral care products, severe oral cavity sensitivity, or
excessive oral irritation;
9. Have participated in tooth bleaching or whitening dentifrice trials within the last
three months; and
10. Have had professional or at-home bleaching during the last 6 months.
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