OBJECTIVE: The elmex SENSITIVE extra soft toothbrush, with soft conical filaments designed for plaque removal specifically in the cervical area and interdental spaces, and gentleness for hypersensitive teeth with exposed dentine, was evaluated for plaque removal effectiveness, safety, and subjective satisfaction. METHODS:One-hundred and seven healthy adults participated in the clinical trial designed according to American Dental Association (ADA) guidelines, and were randomly divided into a test group (N = 54) using the elmex brush, and a control group (N = 53) using the ADA reference brush. Subjects were chosen with gingival recession resulting in exposed dental necks and reported sensitivity, and were given a pre-study cleaning by a hygienist. Clinical examinations included the Rustogi plaque index (before and after brushing), and an examination for any soft lesion adverse effects, at baseline, 30, and 60 days. A subjective questionnaire, measuring satisfaction, sensitivity, and painless brushing, was administered at 30 and 60 days. An ANCOVA model, with baseline level as the covariate, was employed for testing clinical differences between groups at one and two months. The Mann-Whitney test measured differences in the satisfaction questionnaires. RESULTS: The total plaque index, after brushing and at one and two months, demonstrated a significantly higher mean level for the control compared to the test group (3.05 vs. 2.16; p = 0.001 and 3.47 vs. 2.56; p = 0.0003, respectively). Similar significant differences were detected for plaque levels at the gingival margin and the proximal dental surfaces, after brushing at one and two months. No significant differences were found pre-brushing at any of the measurement points. Most subjective assessments of the two brushes at one and two months revealed significant differences in favor of the test brush. CONCLUSION: These results indicate an effective toothbrush for promoting oral health, and patient acceptance of a toothbrush with soft conical filaments intended specifically for sensitive teeth.
RCT Entities:
OBJECTIVE: The elmex SENSITIVE extra soft toothbrush, with soft conical filaments designed for plaque removal specifically in the cervical area and interdental spaces, and gentleness for hypersensitive teeth with exposed dentine, was evaluated for plaque removal effectiveness, safety, and subjective satisfaction. METHODS: One-hundred and seven healthy adults participated in the clinical trial designed according to American Dental Association (ADA) guidelines, and were randomly divided into a test group (N = 54) using the elmex brush, and a control group (N = 53) using the ADA reference brush. Subjects were chosen with gingival recession resulting in exposed dental necks and reported sensitivity, and were given a pre-study cleaning by a hygienist. Clinical examinations included the Rustogi plaque index (before and after brushing), and an examination for any soft lesion adverse effects, at baseline, 30, and 60 days. A subjective questionnaire, measuring satisfaction, sensitivity, and painless brushing, was administered at 30 and 60 days. An ANCOVA model, with baseline level as the covariate, was employed for testing clinical differences between groups at one and two months. The Mann-Whitney test measured differences in the satisfaction questionnaires. RESULTS: The total plaque index, after brushing and at one and two months, demonstrated a significantly higher mean level for the control compared to the test group (3.05 vs. 2.16; p = 0.001 and 3.47 vs. 2.56; p = 0.0003, respectively). Similar significant differences were detected for plaque levels at the gingival margin and the proximal dental surfaces, after brushing at one and two months. No significant differences were found pre-brushing at any of the measurement points. Most subjective assessments of the two brushes at one and two months revealed significant differences in favor of the test brush. CONCLUSION: These results indicate an effective toothbrush for promoting oral health, and patient acceptance of a toothbrush with soft conical filaments intended specifically for sensitive teeth.