Conditions: Oral Health
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 15
Healthy volunteers: yes

Brief summary:
This study investigated the ability of two zinc-containing toothpaste formulations (Zinc A and Zinc B) to reduce the level of bacteria in saliva in the two-hour period after their use, compared to the effect of rinsing with water alone.

Detailed description:
This was a single centre, three treatment, randomized, blinded, cross-over study which involved rinsing with slurries of two sodium fluoride-silica dentifrices containing zinc chloride and sodium citrate, and with water alone. The study consisted of four Visits: Visit 1 (Screening), Visit 2 (Treatment 1), Visit 3 (Treatment 2), Visit 4 (Treatment 3). There was a minimum two days wash out period before the first treatment visit and between treatment visits to avoid any treatment carry-over effect. During that time participants brushed as normal (twice-daily) at home with a washout toothpaste and a toothbrush which was provided at screening. Participants were required not to brush their teeth on the morning of the treatment visits and not to eat or drink for 2 hours prior to the treatment visits.

Arms:
arm 1: In this arm, participants received Zinc-A toothpaste (test product 1) in the form of slurry. arm 2: In this arm, participants received Zinc-B toothpaste (test product 2) in the form of slurry. arm 3: In this arm, participants received mineral water.

Interventions: intervention 1: Zinc-A toothpaste intervention 2: Zinc-B toothpaste intervention 3: Mineral water
Intervention descriptions: intervention 1: Participants received 6.0 grams (g) \[± 0.3g\] of the Zinc-A toothpaste in the form of slurry, one day per treatment (with at least 2 \[generally 7\] days between treatments. Participants emptied the contents of the dosing cup into their mouth, swilled the product around their mouth for 2 timed minutes then they expectorated into a sink. intervention 2: Participants received 6.0 grams (g) \[± 0.3g\] of the Zinc-B toothpaste in the form of slurry, one day per treatment (with at least 2 \[generally 7\] days between treatments. Participants emptied the contents of the dosing cup into their mouth, swilled the product around their mouth for 2 timed minutes then they expectorated into a sink. intervention 3: Participants received 6.0g (±0.3g) of mineral water (by weighing out), one day per treatment (with at least 2 \[generally 7\] days between treatments). Participants emptied the contents of the dosing cup into their mouth, swilled the product around their mouth for 2 timed minutes then they expectorated into a sink.

Protocol document: