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Clinical Trials/NCT02637830
NCT02637830CompletedNot Applicable

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

University of Sao Paulo0 sites12 target enrollmentStarted: January 1, 2012Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
12
Primary Endpoint
The increase of hardness (KHN or KgF/mm2) artificial caries lesions using surface and cross-sectional hardness

Study Overview

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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 30 Years (Adult)
Sex
All
Accepts 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.

Arms & Interventions

Fluoride varnish and fluoride toothpaste

Experimental

Application of fluoride varnish (Duraphat) at the begining of the study. Application of fluoride toothpaste (Crest) twice a day for 3 days.

Intervention: Application of fluoride toothpaste (1500 ppm F, Crest) twice a day for 3 days of the study (Other)

Fluoride varnish and fluoride toothpaste

Experimental

Application of fluoride varnish (Duraphat) at the begining of the study. Application of fluoride toothpaste (Crest) twice a day for 3 days.

Intervention: Application of fluoride varnish (22600 ppm F, Duraphat) at the begining of the study (Other)

placebo toothpaste

Placebo Comparator

Application of placebo toothpaste twice a day for 3 days

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

Fluoride toothpaste

Active Comparator

Application of fluoride toothpaste (Crest) twice a day for 3 days

Intervention: Application of fluoride toothpaste (1500 ppm F, Crest) twice a day for 3 days of the study (Other)

Outcomes

Primary Outcomes

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

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

Time Frame: 3 days

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ana Carolina Magalhães

Prof. Dr.

University of Sao Paulo

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