Evaluation of a Test Mouthwash and Dentifrice Regimen in an In-situ Model of Dental Erosion

NCT ID: NCT01128972

Last Updated: 2015-01-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2009-10-31

Brief Summary

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An in situ model will be used to evaluate and compare enamel remineralization of bovine enamel specimens.

Detailed Description

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Conditions

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Tooth Erosion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Test Dentifrice + Test Mouth Rinse (MR)

Test fluoride dentifrice and test fluoride MR

Group Type EXPERIMENTAL

Sodium fluoride

Intervention Type DRUG

Test fluoride toothpaste and test fluoride mouth rinse

Test Dentifrice + Sterile Water Rinse

Test fluoride dentifrice and sterile water rinse

Group Type EXPERIMENTAL

Sodium fluoride

Intervention Type DRUG

Test fluoride toothpaste and test fluoride mouth rinse

Sterile water

Intervention Type DRUG

Sterile water rinse

Placebo Dentifrice + Test MR

Placebo dentifrice and test fluoride rinse

Group Type EXPERIMENTAL

Sodium fluoride

Intervention Type DRUG

Test fluoride toothpaste and test fluoride mouth rinse

Reference Dentifrice + Sterile Water Rinse

Marketed fluoride dentifrice with sterile water rinse

Group Type ACTIVE_COMPARATOR

Sodium fluoride

Intervention Type DRUG

Test fluoride toothpaste and test fluoride mouth rinse

Sodium monoflurophosphate

Intervention Type DRUG

United Kingdom marketed fluoride toothpaste

Sterile water

Intervention Type DRUG

Sterile water rinse

Placebo Dentifrice + Sterile Water Rinse

Placebo dentifrice and sterile water rinse

Group Type PLACEBO_COMPARATOR

Sterile water

Intervention Type DRUG

Sterile water rinse

Interventions

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Sodium fluoride

Test fluoride toothpaste and test fluoride mouth rinse

Intervention Type DRUG

Sodium monoflurophosphate

United Kingdom marketed fluoride toothpaste

Intervention Type DRUG

Sterile water

Sterile water rinse

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* An intact maxillary dental arch suitable for the retention of the palatal appliance and an intact mandibular dental arch - subjects may have fixed bridges replacing missing teeth
* No current active caries or periodontal disease that may compromise the study or the health of the subjects
* A gum base stimulated whole saliva flow rate greater than or equal to 0.8 mL/minute and an unstimulated whole saliva flow rate greater than or equal to 0.2 mL/minute

Exclusion Criteria

* Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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Indiana University School of Dentistry

Indianapolis, Indiana, United States

Site Status

Countries

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United States

References

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Maggio B, Guibert RG, Mason SC, Karwal R, Rees GD, Kelly S, Zero DT. Evaluation of mouthrinse and dentifrice regimens in an in situ erosion remineralisation model. J Dent. 2010 Nov;38 Suppl 3:S37-44. doi: 10.1016/S0300-5712(11)70007-0.

Reference Type BACKGROUND
PMID: 21256403 (View on PubMed)

Other Identifiers

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Z3480664

Identifier Type: -

Identifier Source: org_study_id

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