In Situ Remineralisation Response of Different Artificial Caries-like Enamel Lesions to Home-care and Professional Fluoride Treatments
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Sao Paulo
- 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
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
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
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
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
Ana Carolina Magalhães
Prof. Dr.
University of Sao Paulo
