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

NCT01128972 | Completed Phase 2 Results

• 1 other identifier: Z3480664
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tooth Erosion

Keywords

enamel erosion; tooth remineralization; tooth erosion

Outcome Measures

Primary Outcomes (1)

• Adjusted Mean Percent Net Erosion Resistance (NER) of Enamel Specimens Exposed to Test Dentifrice + Test MR Relative to: 1) Test Dentifrice+ Sterile Water Rinse 2) Reference Dentifrice+ Sterile Water Rinse 3) Placebo Dentifrice+ Sterile Water Rinse

  Enamel specimens were exposed to dietary erosive challenge and set of five indentations within each specimen was measured. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine NER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent NER was calculated by formula: \[(E1-E2)/ (E1-B)\]\*100. Smaller the negative NER, better is treatment regimen in imparting resistance to enamel.

  Baseline, 4 hours post treatment in each treatment period

Secondary Outcomes (1)

• Adjusted Mean Percentage Surface Microhardness (SMH) Recovery of Enamel Specimens Exposed to Test Dentifrice + Test MR Relative to: 1)Test Dentifrice+Sterile Water Rinse 2)Reference Dentifrice+Sterile Water Rinse 3)Placebo Dentifrice+ Sterile Water Rinse

  Baseline, 4 hours post treatment in each treatment period.

Other Outcomes (4)

• Adjusted Mean Percent NER of Enamel Specimens Exposed to a Treatment Regimen of Placebo Dentifrice + Test MR Relative to: 1) Test Dentifrice +Test MR 2) Test Dentifrice + Sterile Water Rinse 3) Reference Dentifrice +Sterile Water Rinse

  Baseline, 4 hours post treatment in each treatment period

• Adjusted Mean Percentage SMH Recovery of Enamel Specimens Exposed to Test Dentifrice + Test MR Relative to Following Treatment Regimens: 1) Test Dentifrice +Test MR 2) Test Dentifrice + Sterile Water 3) Reference Dentifrice +Sterile Water

  Baseline, 4 hours post treatment in each treatment period

• Adjusted Mean Percent NER of Enamel Specimens Exposed to Test Dentifrice +Sterile Water Rinse and Reference Dentifrice +Sterile Water Rinse

  Baseline, 4 hours post treatment in each treatment period

Study Arms (5)

Test Dentifrice + Test Mouth Rinse (MR)

EXPERIMENTAL

Test fluoride dentifrice and test fluoride MR

Drug: Sodium fluoride

Test Dentifrice + Sterile Water Rinse

EXPERIMENTAL

Test fluoride dentifrice and sterile water rinse

Drug: Sodium fluoride; Drug: Sterile water

Placebo Dentifrice + Test MR

EXPERIMENTAL

Placebo dentifrice and test fluoride rinse

Drug: Sodium fluoride

Reference Dentifrice + Sterile Water Rinse

ACTIVE COMPARATOR

Marketed fluoride dentifrice with sterile water rinse

Drug: Sodium fluoride; Drug: Sodium monoflurophosphate; Drug: Sterile water

Placebo Dentifrice + Sterile Water Rinse

PLACEBO COMPARATOR

Placebo dentifrice and sterile water rinse

Drug: Sterile water

Interventions

Sodium fluoride DRUG

Test fluoride toothpaste and test fluoride mouth rinse

Placebo Dentifrice + Test MR; Reference Dentifrice + Sterile Water Rinse; Test Dentifrice + Sterile Water Rinse; Test Dentifrice + Test Mouth Rinse (MR)

Sodium monoflurophosphate DRUG

United Kingdom marketed fluoride toothpaste

Reference Dentifrice + Sterile Water Rinse

Sterile water DRUG

Sterile water rinse

Placebo Dentifrice + Sterile Water Rinse; Reference Dentifrice + Sterile Water Rinse; Test Dentifrice + Sterile Water Rinse

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

Indiana University School of Dentistry

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

• 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.

  PMID: 21256403 BACKGROUND

MeSH Terms

Conditions

Tooth Erosion

Interventions

Sodium Fluoride

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Tooth Wear

Intervention Hierarchy (Ancestors)

Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Sodium Compounds; Cariostatic Agents; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2010
• First Posted: May 24, 2010
• Study Start: August 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: January 1, 2015
• Results First Posted: April 25, 2013

Record last verified: 2014-12

Locations

US (1)