NCT Number: NCT02637830
In Situ Remineralisation Response of Different Artificial Caries-like Enamel Lesions to Home-care and Professional Fluoride Treatments
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).
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Notify MeKey information
Age range
18 year–30 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- a stimulated physiological salivary flow rate of >1 ml.min-1
- 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
- systemic illness
- pregnancy or breastfeeding
- use of fixed or removable orthodontic appliances
- use of fluoride mouthrinse or professional fluoride application in the last 2 months.
Treatment and study plan
Application of fluoride toothpaste (1500 ppm F, Crest) twice a day for 3 days of the study
OtherApplication of placebo toothpaste (0 ppm F, Ice Fresh) twice a day for 3 days of the study
OtherPrimary outcomes
-
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
Sponsors and collaborators
Lead sponsor
University of Sao Paulo
Other
Registry information
Important dates
- Study start
- 2012
- Primary completion
- 2012
- Study completion
- 2012
- First posted
- Dec 22, 2015
- Registry last updated
- Dec 24, 2015
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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