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In Situ Remineralisation Response of Different Artificial Caries-like Enamel Lesions to Home-care and Professional Fluoride Treatments

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02637830
Enrollment
12
Registered
2015-12-22
Start date
2012-01-31
Completion date
2012-12-31
Last updated
2015-12-24

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

Conditions

Dental Caries

Brief summary

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).

Interventions

OTHERApplication of fluoride varnish (22600 ppm F, Duraphat) at the begining of the study
OTHERApplication 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

Sponsors

University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
The increase of mineral content (% mineral volume) using transverse microradiography3 days
The increase of hardness (KHN or KgF/mm2) artificial caries lesions using surface and cross-sectional hardness3 days
Decrease of lesion depth (microns) of artificial caries lesions using transverse microradiography3 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026