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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
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    December 8, 2015
    Last Updated
    December 22, 2015
    Sponsor
    University of Sao Paulo
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    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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