Conditions: Dentin Sensitivity
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 240
Healthy volunteers: yes

Brief summary:
This study will investigate the longitudinal efficacy of two experimental oral rinses containing 1.5% weight/weight (w/w) dipotassium oxalate monohydride (KOX), formulated at pH 4.5 and pH 7 respectively, for the relief of dentinal hypersensitivity (DH), compared to a placebo oral rinse, when used as an adjunct to twice daily brushing with a standard fluoride toothpaste.

Detailed description:

Arms:
arm 1: Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 ml of Experimental Oral Rinse 1 for 1 minute. This regimen will be performed twice daily for 8 weeks. arm 2: Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 ml of Experimental Oral Rinse 2 for 1 minute. This regimen will be performed twice daily for 8 weeks. arm 3: Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 ml of Placebo Oral Rinse 2 for 1 minute. This regimen will be performed twice daily for 8 weeks.

Interventions: intervention 1: Experimental Oral Rinse 1 intervention 2: Experimental Oral Rinse 2 intervention 3: Placebo Oral Rinse intervention 4: Standard fluoride toothpaste
Intervention descriptions: intervention 1: (1.5% w/w KOX, pH 4.5) intervention 2: (1.5% w/w KOX, pH 7) intervention 3: (0% w/w KOX, pH 4.5) intervention 4: 1000ppm fluoride as sodium monofluorophosphate

Protocol document: