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).

Study Overview

• Status: Completed
• Conditions: Dental Caries
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fluoride varnish and fluoride toothpaste; 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 Comparator: placebo toothpaste; 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
Active Comparator: Fluoride toothpaste; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Sao Paulo

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: December 8, 2015
• First Submitted That Met QC Criteria: December 21, 2015
• First Posted (Estimate): December 22, 2015

Study Record Updates

• Last Update Posted (Estimate): December 24, 2015
• Last Update Submitted That Met QC Criteria: December 22, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries; Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides; Fluorides, Topical; Sodium fluoride topical preparation
• Other Study ID Numbers: 036/2011