In Situ Remineralisation Response of Different Artificial Caries-like Enamel Lesions to Home-care and Professional Fluoride Treatments
Primary Purpose
Dental Caries
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
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
Sponsored by
About this trial
This is an interventional treatment trial for Dental Caries
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Active Comparator
Arm Label
Fluoride varnish and fluoride toothpaste
placebo toothpaste
Fluoride toothpaste
Arm Description
Application of fluoride varnish (Duraphat) at the begining of the study. Application of fluoride toothpaste (Crest) twice a day for 3 days.
Application of placebo toothpaste twice a day for 3 days
Application of fluoride toothpaste (Crest) twice a day for 3 days
Outcomes
Primary Outcome Measures
The increase of mineral content (% mineral volume) using transverse microradiography
The increase of hardness (KHN or KgF/mm2) artificial caries lesions using surface and cross-sectional hardness
Decrease of lesion depth (microns) of artificial caries lesions using transverse microradiography
Secondary Outcome Measures
Full Information
NCT ID
NCT02637830
First Posted
December 8, 2015
Last Updated
December 22, 2015
Sponsor
University of Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT02637830
Brief Title
In Situ Remineralisation Response of Different Artificial Caries-like Enamel Lesions to Home-care and Professional Fluoride Treatments
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fluoride varnish and fluoride toothpaste
Arm Type
Experimental
Arm Description
Application of fluoride varnish (Duraphat) at the begining of the study. Application of fluoride toothpaste (Crest) twice a day for 3 days.
Arm Title
placebo toothpaste
Arm Type
Placebo Comparator
Arm Description
Application of placebo toothpaste twice a day for 3 days
Arm Title
Fluoride toothpaste
Arm Type
Active Comparator
Arm Description
Application of fluoride toothpaste (Crest) twice a day for 3 days
Intervention Type
Other
Intervention Name(s)
Application of fluoride varnish (22600 ppm F, Duraphat) at the begining of the study
Intervention Type
Other
Intervention Name(s)
Application of fluoride toothpaste (1500 ppm F, Crest) twice a day for 3 days of the study
Intervention Type
Other
Intervention Name(s)
Application of placebo toothpaste (0 ppm F, Ice Fresh) twice a day for 3 days of the study
Primary Outcome Measure Information:
Title
The increase of mineral content (% mineral volume) using transverse microradiography
Time Frame
3 days
Title
The increase of hardness (KHN or KgF/mm2) artificial caries lesions using surface and cross-sectional hardness
Time Frame
3 days
Title
Decrease of lesion depth (microns) of artificial caries lesions using transverse microradiography
Time Frame
3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
12. IPD Sharing Statement
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In Situ Remineralisation Response of Different Artificial Caries-like Enamel Lesions to Home-care and Professional Fluoride Treatments
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