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

Not Applicable

Completed

• Conditions: Dental Caries
• Interventions: 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; Other: Application of placebo toothpaste (0 ppm F, Ice Fresh) twice a day for 3 days of the study

• Registration Number: NCT02637830
• Lead Sponsor: University of Sao Paulo

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2012-06
• Study Completion: 2012-12
• Status Verified: 2015-12
• Study First Submitted: 2015-12-08
• Study First Submitted QC: 2015-12-21
• Study First Posted: 2015-12-22
• Last Update Submitted: 2015-12-22
• Last Update Posted: 2015-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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)

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Fluoride varnish and fluoride toothpaste	Application of fluoride varnish (22600 ppm F, Duraphat) at the begining of the study	Application of fluoride varnish (Duraphat) at the begining of the study. Application of fluoride toothpaste (Crest) twice a day for 3 days.
Fluoride toothpaste	Application of fluoride toothpaste (1500 ppm F, Crest) twice a day for 3 days of the study	Application of fluoride toothpaste (Crest) twice a day for 3 days
Fluoride varnish and fluoride toothpaste	Application of fluoride toothpaste (1500 ppm F, Crest) twice a day for 3 days of the study	Application of fluoride varnish (Duraphat) at the begining of the study. Application of fluoride toothpaste (Crest) twice a day for 3 days.
placebo toothpaste	Application of placebo toothpaste (0 ppm F, Ice Fresh) twice a day for 3 days of the study	Application of placebo toothpaste twice a day for 3 days

Primary Outcome Measures

Name	Time	Method
The increase of mineral content (% mineral volume) using transverse microradiography	3 days
The increase of hardness (KHN or KgF/mm2) artificial caries lesions using surface and cross-sectional hardness	3 days
Decrease of lesion depth (microns) of artificial caries lesions using transverse microradiography	3 days