RecruitingACTRN12623000893606

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


Sponsor

The University of Melbourne

Enrollment

40 participants

Start Date

Oct 10, 2023

Study Type

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

Sex: Both males and femalesMin Age: 18 YearssMax Age: 75 Yearss

Plain Language Summary

Simplified for easier understanding

Gum disease (gingivitis) is caused by a buildup of plaque on teeth and the bacteria that live in it. This study is testing whether a special toothpaste called GC MI Paste One Perio — which contains a milk-derived protein complex (CPP-ACP) plus stannous fluoride — has a different effect on gum health and the bacteria in your mouth compared to a standard stannous fluoride toothpaste (Colgate Total SF). Participants will be randomly assigned to brush with one of the two toothpastes three times a day for 21 days, with no other oral hygiene products allowed during this time. Gum health, plaque levels, and the types of bacteria present in the mouth will all be measured before and after. The idea is that the CPP-ACP ingredient might act like a prebiotic, encouraging a healthier mix of mouth bacteria. You may be eligible if you are aged 18 to 75, have at least 20 natural teeth, have some gum inflammation and plaque build-up, and are in good general health. People with orthodontic braces, crowns on most front teeth, gum disease requiring clinical treatment, or allergies to milk protein or tin are not eligible. The study is based at the University of Melbourne.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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

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.


Locations(1)

VIC, Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12623000893606


Related Trials