An interventional study of Application of fluoride varnish (22600 ppm F, Duraphat) at the begining of the study and Application of fluoride toothpaste (1500 ppm F, Crest) twice a day for 3 days of the study in Dental Caries, sponsored by University of Sao Paulo. Completed. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-12-24.
Sponsored by University of Sao Paulo · Not applicable, Interventional, and Treatment
This study mainly compared the response of the artificial carious enamel lesions to remineralisation in situ. The tested in vitro demineralising protocols were: MC gel, PA gel, MHDP and Buffer solutions.
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).
1,109 studies on the registry are indexed under Dental Caries; 197 are open to participants now.
This study's enrollment of 12 is below the median of 60 across 916 interventional studies indexed under Dental Caries.
Browse Dental Caries studies →University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Application of fluoride varnish (Duraphat) at the begining of the study. Application of fluoride toothpaste (Crest) twice a day for 3 days.
Other: Application of fluoride varnish (22600 ppm F, Duraphat) at the begining of the study · Other: Application of fluoride toothpaste (1500 ppm F, Crest) twice a day for 3 days of the study
Application of placebo toothpaste twice a day for 3 days
Other: Application of placebo toothpaste (0 ppm F, Ice Fresh) twice a day for 3 days of the study
Application of fluoride toothpaste (Crest) twice a day for 3 days
Other: Application of fluoride toothpaste (1500 ppm F, Crest) twice a day for 3 days of the study
The increase of mineral content (% mineral volume) using transverse microradiography
Time frame: 3 days
The increase of hardness (KHN or KgF/mm2) artificial caries lesions using surface and cross-sectional hardness
Time frame: 3 days
Decrease of lesion depth (microns) of artificial caries lesions using transverse microradiography
Time frame: 3 days
No study locations are listed for this record.
This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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University of Sao Paulo