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Completed

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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Key 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 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

Other

Application of placebo toothpaste (0 ppm F, Ice Fresh) twice a day for 3 days of the study

Other

Primary outcomes

  1. The increase of mineral content (% mineral volume) using transverse microradiography

    Time frame: 3 days

  2. The increase of hardness (KHN or KgF/mm2) artificial caries lesions using surface and cross-sectional hardness

    Time frame: 3 days

  3. 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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