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Effects of different toothpastes on fluorides kinetics release to saliva in healthy adult subjects

Effects of different toothpastes on fluorides kinetics release to saliva in healthy adult subjects: a three-arm parallel single-centre randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN79212143
Enrollment
66
Registered
2014-11-04
Start date
2014-03-19
Completion date
Unknown
Last updated
2015-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy adult volunteers Oral Health

Interventions

Salivary secretion capacity will be assessed in all participants at baseline. The participants will randomly be allocated to the control and intervention arms in equal numbers (22 in each arm): 1. I
Portugal), Salivary secretion rate and fluoride concentration will be recorded at defined time intervals (before toothbrushing at 0 and 10 minutes
after toothbrushing at 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90, 100, 110 and 120 minutes) to determine if the amount of fluoride would be able to induce toxic effects in the human bod

Sponsors

University of Lisbon (Portugal)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Above 18 years 2. An unstimulated whole saliva flow higher than 0.1 mL/min 3. Healthy volunteers, without any systemic pathologies

Exclusion criteria

Exclusion criteria: 1. Pregnant 2. Medication that induce xerostomia 3. Does not meet inclusion criteria

Design outcomes

Primary

MeasureTime frame
Amount of fluoride present in saliva during and after toothpaste use, expressed in milligrams, as the mean ± 95% confidence interval. Fluoride present in the toothbrush, mouthwash and in saliva after toothpaste use, expressed in parts per million will be determined using metric techniques and a fluoride selective electrode. This value will be converted into milligrams, according to each dentifrice and its fluoride concentration. Percentage values will be determined, considering the toothpaste placed on the toothbrush (expressed in grams, and calculated from the difference of weight of the toothbrush before and after toothpaste placement) as the total amount of fluoride, meaning 100% of fluoride of exposure. All the fluoride accumulated in saliva will be determined and, based on this value, calculation will be performed for each dentifrice to determine how many times a patient would have to brush his teeth per day to cause any deleterious effect, according to the reference values for acute and chronic fluoride toxicity in the literature.

Secondary

MeasureTime frame
1. Concentration of fluoride present in saliva before, during and after toothpaste use, expressed in parts per million, as the mean ± 95% confidence interval 2. Amount of paste placed in the toothbrush, expressed in grams, as the mean ± 95% confidence interval 3. Fluoride wasted in the toothbrush and in the mouthwash, expressed in grams, as the mean ± 95% confidence interval 4. Fluoride wasted in the toothbrush and in the mouthwash, expressed in ppm, as the mean ± 95% confidence interval 5. Fluoride present in the toothbrush, mouthwash and in saliva after toothpaste use, expressed in percentage, as the mean ± 95% confidence interval 6. Salivary flow after brushing with the dentifrices, expressed in milliliters per minute, as the mean ± 95% confidence interval

Countries

Portugal

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026