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Trial record 46 of 292 for:    Sodium Fluoride OR Duraphat

Effect of Fluoride in a Dentifrice on Remineralization of Erosive Lesions

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ClinicalTrials.gov Identifier: NCT01641237
Recruitment Status : Completed
First Posted : July 16, 2012
Results First Posted : July 31, 2013
Last Update Posted : July 24, 2014
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
The proposed study will evaluate the performance of fluoride delivered from a new dentifrice formulation without potassium nitrate. It will also evaluate the dose-response to fluoride by testing four dentifrices covering a range of sodium fluoride concentration.

Condition or disease Intervention/treatment Phase
Enamel Erosion Drug: sodium fluoride Drug: no added fluoride in a silica base Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Fluoride in an Experimental Dentifrice on Remineralization of Erosive Lesions In-Situ
Study Start Date : March 2012
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Low ppm fluoride dentifrice
Low ppm fluoride as sodium fluoride in a silica base dentifrice
Drug: sodium fluoride
fluoride as sodium fluoride

Experimental: Medium ppm fluoride dentifrice
Medium ppm fluoride as sodium fluoride in a silica base dentifrice
Drug: sodium fluoride
fluoride as sodium fluoride

Experimental: High ppm fluoride dentifrice
High ppm fluoride as sodium fluoride in a silica base dentifrice
Drug: sodium fluoride
fluoride as sodium fluoride

Placebo Comparator: No fluoride dentifrice
no added fluoride in a silica base dentifrice
Drug: no added fluoride in a silica base
no added fluoride




Primary Outcome Measures :
  1. Percentage Surface Microhardness Recovery (%SMHR) Dose Response Relationship [ Time Frame: Baseline to 4 hours ]
    SMHR test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1-R)/ (E1-B)]*100.


Secondary Outcome Measures :
  1. %SMHR [ Time Frame: Baseline to 4 hours ]
    SMHR test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1-R)/ (E1-B)]*100.

  2. Percentage Relative Erosion Resistance [ Time Frame: Baseline to 4 hours ]
    Changes in mineral content of enamel specimens exposed to dietary erosive challenge were determined by measuring the length of the indentations. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine relative erosion resistance which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent relative erosion resistance was calculated by formula: [(E1-E2)/ (E1-B)]*100.

  3. Enamel Fluoride Uptake (Corrected Data) [ Time Frame: Baseline to 4 hours ]
    Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on amount of fluoride divided by area of the enamel cores. Data analysis was based on corrected data.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • intact maxillary dental arch suitable to retain a palatal appliance, an intact mandibular dental arch and a stimulated/unstimulated saliva flow rate of ≥ 0.8 milliliter/minute (ml/min) and ≥ 0.2 ml/min respectively.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01641237


Locations
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United States, Indiana
Indiana University School of Dentistry
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01641237     History of Changes
Other Study ID Numbers: RH01299
First Posted: July 16, 2012    Key Record Dates
Results First Posted: July 31, 2013
Last Update Posted: July 24, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
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Listerine
Fluorides
Sodium Fluoride
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents