To assess the efficacy of a toothpaste containing chitosan in reducing plaque, gingivitis, and gingival bleeding, compared with Colgate Cavity Protection Toothpaste
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
90
Toothpaste containing chitosan and a commercially available soft-bristled toothbrush
Fluoride Toothpaste and a commercially available soft-bristled toothbrush
West China Dental Institute of Chengdu
Chengdu, Sichuan, China
Modified Gingival Index (MGI_ Lobene)
Clinical assessments will be carried out using the Modified Gingival Index (MGI; Lobene et al., 1986).MGI scoring criteria: 0: Absence of inflammation 1. Mild inflammation; slight change in color, little change in texture of any portion of, but not the entire, marginal or papillary gingival unit 2. Mild inflammation; as above, but involving the entire marginal or papillary gingival unit 3. Moderate inflammation; glazing, redness, edema, and/or hypertrophy of the marginal or papillary gingival unit 4. Severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration
Time frame: Baseline, 2 week, 1 month & 3 month
Modified Plaque Index (MPI_ Turesky)
Using a red disclosing solution, a Modified Plaque Index (Turesky et al, 1970) score of 0-5 will be assigned to all scorable disclosed surfaces of the maxillary and mandibular teeth using a dental light and dental mirror. A whole-mouth score will be determined by summing the values for all scorable surfaces and dividing by the total number of surfaces scored. Modified Plaque Index (Turesky) scoring criteria: 0: No plaque 1. Separate flecks of plaque at the cervical margin 2. A thin, continuous band of plaque (up to 1 mm) at the cervical margin 3. A band of plaque wider than 1 mm but covering less than one-third of the crown 4. Plaque covering at least one-third but less than two-thirds of the crown 5. Plaque covering two-thirds or more of the crown
Time frame: Baseline, 2 week, 1 month & 3 month
Gingival Bleeding Index (GBI_ Saxton)
The examiner will conduct the Gingival Bleeding Index (GBI) examinations using the Saxton and van der Ouderaa methodology and a CPITN periodontal probe (0.5 mm ball end). Findings and GBI score calculations (including bleeding severity) will be recorded on the Gingival Bleeding Index Examination Form.
Time frame: Baseline, 2 week, 1 month & 3 month
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