None listed
Conditions
Brief 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.
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 di
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.
Sponsors
The University of Melbourne
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion Criteria: To be eligible to participate in this study, an individual must meet all of the following criteria: 1. Ability to understand, and willingness and ability to read and sign, the informed consent form. 2. Age range: 18 to 75 years old. 3. Good general health. 4. Minimum of 20 natural teeth. 5. A gum-stimulated whole salivary flow rate greater than or equal to 1.0 ml/minute and unstimulated whole salivary flow rate greater than or equal to 0.2 ml/minute. 6. A baseline mean whole-mouth modified gingival index greater than or equal to 1.2. 7. A baseline mean whole-mouth plaque index greater than or equal to 1.5. 8. Willingness to comply with all study procedures and be available for the duration of the study.
Exclusion criteria
Exclusion Criteria: Individuals who manifest ANY of the following exclusion criteria at the time of randomization will NOT be eligible for the study: 1. Allergy to milk protein, tin or other ingredients in toothpaste products. 2. Orthodontic appliances or removable prostheses. 3. Veneers, or more than one incisor with a prosthetic crown. 4. Gross oral pathology (including periodontal disease {Community Periodontal Index of Treatment Needs [CPITN] greater than or equal to 3} and tumours of the soft or hard oral tissues). 5. Chronic disease with concomitant oral manifestations (e.g., diabetes [irrespective of level of control], human immunodeficiency virus infection or acquired immunodeficiency syndrome, use of medications associated with gingival hyperplasia). 6. Unrestored dentinal caries. 7. Treatment with antibiotics or anti-inflammatory medication in the month prior to starting the study. 8. Concomitant pharmacotherapy with drugs that may interact with test drug. 9. History of conditions requiring antibiotic coverage prior to invasive dental procedures. 10. Pregnancy/lactation.
Outcome results
None listed