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

Dental Caries Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02637830
• Other study ID #: 036/2011
• Status: Completed
• Phase: N/A
• First received: December 8, 2015
• Last updated: December 22, 2015
• Start date: January 2012
• Est. completion date: December 2012

Study information

• Verified date: December 2015
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 30 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Caries

Intervention

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

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

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The increase of mineral content (% mineral volume) using transverse microradiography		3 days	No
Primary	The increase of hardness (KHN or KgF/mm2) artificial caries lesions using surface and cross-sectional hardness		3 days	No
Primary	Decrease of lesion depth (microns) of artificial caries lesions using transverse microradiography		3 days	No