The goal of this clinical trial is to learn if powered toothbrushing with a side-to-side motion is more effective than powered toothbrushing with oscillating-rotation motion in removing dental plaque. It will also learn about the safety of power toothbrushing with both products. The main questions the study aims to answer are: Does side-to-side power toothbrushing remove more dental plaque than oscillating-rotation toothbrushing? Does side-to-side power toothbrushing reduce symptoms of gingivitis better than oscillating-rotation toothbrushing? Participants will: Brush their teeth twice a day with either a side-to-side or oscillating-rotation power toothbrush Visit the clinic twice during the study: once at baseline and six weeks after the study starts. Keep a diary of when they brushed their teeth
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
295
Oral-B iO Series 9
Sonicare 9900 Prestige
Salus Research, Inc.
Fort Wayne, Indiana, United States
Compare the reduction in gingival inflammation for side-to-side powered toothbrush to oscillating-rotating powered toothbrush.
Gingivitis is measured by Modified Gingival Index (MGI) (Lobene et al 1986) using six sites per tooth (distobuccal, buccal, mesiobuccal and distolingual, lingual, mesiolingual) where 0=absence of inflammation, 1. mild inflammation; slight change in color, little change in texture of the marginal or papillary gingival unit, 2. mild inflammation; criteria as shown above but involving the entire marginal or papillary gingiva, 3. moderate inflammation glazing, redness, edema, and/or hypertrophy of the marginal or papillary gingiva, 4. severe inflammation, marked redness, edema, and/or hypertrophy of the marginal or papillary gingiva, spontaneous bleeding, congestion or ulceration. Change in MGI will be calculated by subtracting follow-up MPI score from baseline MGI score. Differences in MGI will be compared between the two powered toothbrush groups.
Time frame: 6 weeks
Compare the reduction in gingival bleeding for side-to-side powered toothbrush to oscillating-rotating powered toothbrush.
Gingival bleeding is measured by Gingival Bleeding Index (GBI), (Van der Weijden et al, 1994) using six sites per tooth (distobuccal, buccal, mesiobuccal and distolingual, lingual, mesiolingual) where 0 = no bleeding, 1. = bleeding on gently probing, 2. = bleeding appears immediately upon gently probing, 3. = spontaneous bleeding which is present prior to probing. Change in GBI will be calculated by subtracting follow-up GBI score from baseline GBI score. Differences in GBI will be compared between the two powered toothbrush groups.
Time frame: 6 weeks
Compare the reduction in surface plaque for side-to-side powered toothbrush to oscillating-rotating powered toothbrush.
Surface plaque is measured by Lobene and Soparkar Modified Quigley-Hein Plaque Index (MPI) using six sites per tooth (distobuccal, buccal, mesiobuccal and distolingual, lingual, mesiolingual) where 0=no plaque, 1. separate flecks of plaque at the cervical margin of the tooth, 2. a thin continuous band of plaque (up to 1 mm) at the cervical margin of the tooth, 3. a band of plaque wider than 1 mm covering less than one third of the crown of the tooth, 4. plaque covering at least one-third but less than two-thirds of the crown of the tooth, 5. plaque covering two-thirds or more of the crown of the tooth. Change in MPI will be calculated by subtracting follow-up MPI score from baseline MPI score. Differences in MPI will be compared between the two powered toothbrush groups.
Time frame: 6 weeks
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