This is a Phase III, randomized, one-center, parallel group, double blinded, clinical study to evaluate the efficacy of an alcohol-free mouthwash containing CPC+Zn as compared to dental flossing and to rising with an essential oils containing alcohol mouthwash in reducing dental plaque and gingivitis. One hundred and twenty participants, aged between 18 and 65 years, will be included and followed for 12 weeks.
This clinical study aims to evaluate the efficacy of a regimen including an alcohol-free mouthwash containing CPC+Zn as compared to dental flossing and brushing and to a regimen including a rinsing with an essential oils containing alcohol mouthwash in reducing dental plaque and gingivitis. This is a Phase III, randomized, one-center, parallel group, double blinded, involving 120 participants, aged 18 to 65. Subjects will be allocated into 3 groups: one - using the CPC+Zn mouthwash, another using the essential oils mouthwash and a control group using dental floss. Each group will also use a fluoride toothpaste and a soft-bristle toothbrush twice daily over 12 weeks. The primary efficacy variable is the reduction of gingival inflammation also Probing Depth, Bleeding on Probing, and a Plaque Index will be accessed. Subjects will undergo baseline, 4-week, and 12-week evaluations, with data analyzed using ANCOVA to assess the efficacy and safety of the products. Adverse events and compliance will be closely monitored, with strict confidentiality maintained for all participants. The study rigorous design aims to provide comprehensive insights into the effectiveness of these oral hygiene regimens.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
Universidad Autónoma de San Luis Potosí
San Luis Potosí City, San Luis Potosí, Mexico
Modified Gingival Index
The Modified Gingival Index (MGI) is used to evaluate the severity of gingivitis by measuring the extent of gingival inflammation. It categorizes gingival health/inflammation on a scale from 0 to 4, where 0 signifies normal gingiva with no inflammation, and 4 indicates severe inflammation characterized by erythema, edema, and spontaneous bleeding.
Time frame: 12 weeks
Turesky modification of Quigley-Hein Plaque Index
The Turesky modification of the Quigley-Hein Plaque Index is a method for assessing dental plaque accumulation by scoring plaque presence on six surfaces of each tooth on a scale from 0 to 5.
Time frame: 12 weeks
Bleeding on probing
Bleeding on probing (BOP) is a diagnostic technique used to assess gingival inflammation by gently probing the gum tissue; the presence of bleeding indicates inflammation and potential periodontal disease.
Time frame: 12 weeks
Probing depth
Probing depth measures the distance between the gingival margin and the bottom of the periodontal pocket using a calibrated periodontal probe, indicating the severity of periodontal disease.
Time frame: 12 weeks
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