Evaluation of the Antibacterial Effect of a Toothpaste Containing Zinc Lactate (NCT05628571) | Clinical Trial Compass
UnknownPhase 3
Evaluation of the Antibacterial Effect of a Toothpaste Containing Zinc Lactate
130 participantsStarted 2023-02-01
Plain-language summary
The aim of this study is to evaluate the antibacterial effect 12 hours after 4-week use of a toothpaste containing amine base, zinc lactate, and fluoride. For this, healthy people will be invited to use two different toothpaste: control - containing only fluoride; test - containing fluoride plus a combination with zinc. The primary outcome is the efficacy of the test toothpaste in the oral bacterial load reduction in samples of saliva and oral mucosa (obtained through scraping); the second outcome is effect of the test toothpaste in the expression of mucin in the oral mucosa.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Male and female subjects, ages 18-70, inclusive;
✓. Subjects are available during study duration;
✓. Subject is in good general health;
✓. A minimum of 15 natural teeth with facial and lingual scorable surfaces, excluding third molars.
✓. A willingness to read, understand, and sign the Informed Consent Form after the nature of the study has been fully explained to them.
✓. Subjects with baseline whole mouth scores of dental plaque of 1.5 or more and gingivitis index of 1.0 or more.
Exclusion criteria
✕. Participation in any other clinical study or test panel including clinical studies with oral hygiene formulations within the one month prior to entry into the study.
✕. History of dental prophylaxis or treatments in the past month or during study duration.
✕. History of medical treatments (e.g: antibiotic, anti-inflammatory, anticoagulant, etc.) during the month preceding study enrollment.
✕. Subjects scheduled for any medical procedure during the course of the study.
✕. Difficulty complying with study procedures and examinations such as excessive gagging during oral assessment etc.
✕. History of significant adverse effects following use of oral hygiene products such as toothpastes and mouthrinses. Allergies to personal care/consumer products or their ingredients.
What they're measuring
1
Change of oral bacteria load
Timeframe: Baseline (previously of the interventions) and after 4 weeks of the interventions