Evaluation of the Prebiotic Effect of New Dentifrice Formulations In Healthy Adults
Effect of a Toothpaste containing Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP) and Stannous Fluoride on Supragingival Plaque Composition and Gingivitis in Healthy Adults
The University of Melbourne
40 participants
Oct 10, 2023
Interventional
Conditions
Summary
This examiner-blinded, randomized controlled clinical trial will use a two-treatment, parallel design to assess the effects of the treatments on the severity of gingivitis, accumulation of supragingival plaque and changes in the microbial composition of supragingival plaque. Participants will be randomly assigned to one of two treatments with each treatment comprising 21 days. The two treatments will be as follows: A. Tooth brushing with GC MI Paste One Perio containing 10% CPP-ACP and stannous fluoride (1100 ppm F) three times a day (after breakfast, after dinner and before bed), with no other oral hygiene procedures over 21 days. B. Tooth brushing with Colgate Total SF containing stannous fluoride (1100 ppm F) three times a day (after breakfast, after dinner and before bed), with no other oral hygiene procedures over 21 days. During the treatment period, all participants will be requested not to brush with any other toothpaste and not to consume any antibiotics or antimicrobials including antimicrobial mints, lozenges, films and chewing gums.
Eligibility
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Interventions
Participants will brush their teeth with the allocated toothpaste (i.e., one of the test products) three times per day for 21 consecutive days at the following times: after breakfast, after dinner and before retiring. Participants will use an amount of toothpaste to completely cover the bristles on their toothbrush. The participants will then brush their teeth for two minutes ensuring they brush all tooth surfaces. After toothbrushing the participants will not eat or drink for 30 minutes. A diary will be provided for each participant to record the times of administration of intervention treatment (i.e., toothbrushing with their allocated toothpaste) each day during the treatment period and returned at the completion of the study.
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ACTRN12623000893606