In Situ Remineralisation Response of Different Artificial Caries-like Enamel Lesions to Home-care and Professional Fluoride Treatments
NCT ID: NCT02637830
Last Updated: 2015-12-24
Study Results
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Basic Information
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COMPLETED
NA
12 participants
INTERVENTIONAL
2012-01-31
2012-12-31
Brief Summary
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The lesions were then remineralised in an in situ model, with crossover and double blind design. Fifteen volunteers wore intra-oral appliances containing 2 bovine enamel samples of each demineralising protocol during 3 experimental phases (3 days each). The experimental phases/treatments were: Control (Placebo dentifrice, saliva effect only), Home-care (fluoride dentifrice, 1,100 ppm F, NaF), and Professional/Home-care (varnish- 22,600 ppm F and dentifrice- 1,100 ppm F, NaF).
During the 3-day phase, the appliance was only removed during the main meals (four times a day, maximum 1 h duration each, interval between meals 2-3 h). Immediately after the meals, before replacing the appliance in the mouth, the subjects were advised to perform oral hygiene using a soft end-rounded toothbrush (Colgate® 360º Sensitive Pro-Relief TM) and dentifrice (non-fluoridated from IceFresh, Bauru, SP, Brazil or fluoridated dentifrice from Crest Procter \& Gamble, Cincinnati, OH, USA) according to the phase and dental floss (Sanifill, São Paulo, Brazil).
The remineralising treatment with dentifrices was done ex vivo, 1 min twice a day (after the first and last oral hygiene of the day) using slurry of the dentifrice (1:3 water, 1 drop of solution/specimen). Thereafter, the appliance was replaced in the mouth and the subjects were advised to rinse with 10 ml of water for 5 s and to expectorate. In respect to Professional/Home-care phase, the varnish (Duraphat, Colgate, SP, Brazil) was applied before the in situ study for 6h and then removed.
The enamel remineralization was quantified using transverse microradiography (% mineral recovery and lesion depth, TMR), surface and cross-sectional hardness. The data were submitted to statistical analysis (p\<0.05).
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Fluoride varnish and fluoride toothpaste
Application of fluoride varnish (Duraphat) at the begining of the study. Application of fluoride toothpaste (Crest) twice a day for 3 days.
Application of fluoride varnish (22600 ppm F, Duraphat) at the begining of the study
Application of fluoride toothpaste (1500 ppm F, Crest) twice a day for 3 days of the study
placebo toothpaste
Application of placebo toothpaste twice a day for 3 days
Application of placebo toothpaste (0 ppm F, Ice Fresh) twice a day for 3 days of the study
Fluoride toothpaste
Application of fluoride toothpaste (Crest) twice a day for 3 days
Application of fluoride toothpaste (1500 ppm F, Crest) twice a day for 3 days of the study
Interventions
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Application of placebo toothpaste (0 ppm F, Ice Fresh) twice a day for 3 days of the study
Application of fluoride varnish (22600 ppm F, Duraphat) at the begining of the study
Application of fluoride toothpaste (1500 ppm F, Crest) twice a day for 3 days of the study
Eligibility Criteria
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Inclusion Criteria
* a non-stimulated physiological salivary flow rate of \>0.25 ml.min-1
* good oral health (i.e. no cavities or significant gingivitis/periodontitis)
Exclusion Criteria
* pregnancy or breastfeeding
* use of fixed or removable orthodontic appliances
* use of fluoride mouthrinse or professional fluoride application in the last 2 months.
18 Years
30 Years
ALL
Yes
Sponsors
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University of Sao Paulo
OTHER
Responsible Party
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Ana Carolina Magalhães
Prof. Dr.
Other Identifiers
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036/2011
Identifier Type: -
Identifier Source: org_study_id