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

NCT02637830 | Completed

• 1 other identifier: 036/2011
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

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.

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

placebo toothpaste

PLACEBO COMPARATOR

Application of placebo toothpaste twice a day for 3 days

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

Fluoride toothpaste

ACTIVE COMPARATOR

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

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

Interventions

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

Fluoride varnish and fluoride toothpaste

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

Fluoride toothpaste; Fluoride varnish and fluoride toothpaste

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

placebo toothpaste

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

MeSH Terms

Conditions

Dental Caries

Interventions

sodium fluoride topical preparation

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: December 8, 2015
• First Posted: December 22, 2015
• Study Start: January 1, 2012
• Primary Completion: June 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 24, 2015

Record last verified: 2015-12