Conditions: Dental Erosion Acid Wear
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 56
Healthy volunteers: yes

Brief summary:
The purpose of this study is to compare and evaluate the ability of two European Union (EU) regulated gel to foam toothpaste formulations versus a non-fluoride toothpaste using a modified in-situ model of dental erosion and remineralization. A positive control i.e fluoride containing toothpaste marketed in EU will also be compared to non-fluoride toothpaste.

Detailed description:
The aim of this study is to assess the remineralization effects of two EU gel to foam toothpaste formulations with 1450 parts per million (ppm) of fluoride as sodium fluoride (NaF) and 5% potassium nitrate (KNO3) versus a non-fluoride (0 ppm F)/KNO3 toothpaste as a negative control. The two experimental gel to foam toothpaste formulations differ in their relative dentine abrasivity (RDA) values which is an in-vitro measure of a toothpaste abrasivity to the dentinal tissues. A marketed toothpaste containing NaF and KNO3 will serve as a positive control.

Arms:
arm 1: Participants to brush with 1.5 g of low RDA gel to foam toothpaste containing 1450 ppm F - EU level as NaF. All study treatments contain 5% weight by weight (w/w) KNO3. arm 2: Participants to brush with 1.5 g of medium RDA gel to foam toothpaste containing 1450 ppm F - EU level as NaF. All study treatments contain 5% w/w KNO3. arm 3: Participants to brush with 1.5 g of NaF/KNO3 toothpaste containing 1450 ppm F - EU level as NaF. All study treatments contain 5% w/w KNO3. arm 4: Participants to brush with a fluoride free toothpaste (0 ppmF). All study treatments contain 5% w/w KNO3.

Interventions: intervention 1: Sodium Fluoride intervention 2: Potassium nitrate
Intervention descriptions: intervention 1: Toothpaste containing 1450 ppm F - EU level as NaF. intervention 2: All study treatments contain 5% w/w KNO3.

Protocol document: