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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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6 July 2015 |
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Main ID: |
ISRCTN79212143 |
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Date of registration:
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04/11/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effects of different toothpastes on fluorides kinetics release to saliva in healthy adult subjects
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Scientific title:
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Effects of different toothpastes on fluorides kinetics release to saliva in healthy adult subjects: a three-arm parallel single-centre randomised controlled trial |
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Date of first enrolment:
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19/03/2014 |
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Target sample size:
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66 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN79212143 |
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Study type:
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Interventional |
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Study design:
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Three-arm parallel single-centre blind randomised controlled trial (Screening)
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Phase:
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Countries of recruitment
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Portugal
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Contacts
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Name:
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António
Duarte Sola Pereira da Mata |
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Address:
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Calçada dos Mestres nº3 4ºFrente
1070-175
Lisbon
Portugal |
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Telephone:
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Email:
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Affiliation:
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Name:
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Key inclusion & exclusion criteria
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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: 1. Pregnant
2. Medication that induce xerostomia
3. Does not meet inclusion criteria
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Healthy adult volunteers
Oral Health
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Intervention(s)
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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. Intervention arm: fluoride highly concentrated dentifrices such as Fluor aid 250® (Dentaid S.L., Spain) and Colgate Duraphat® (Colgate-Palmolive Unipessoal, LDA, Portugal)
2. Control arm: traditional dentifrice, sold freely, Colgate Total® (Colgate-Palmolive Unipessoal, Lda; 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 body.
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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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
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Source(s) of Monetary Support
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University of Lisbon (Portugal) - School of Dental Medicine; GIBBO research unit
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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