A Clinical Study to Evaluate Experimental Children's Toothpastes in an In-Situ Caries Model

NCT01607411 | Completed Phase 3 Results

• 1 other identifier: RH01390
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

An in situ model will be used to evaluate and compare enamel remineralization of human enamel specimens after single use of experimental children's toothpastes.

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (1)

• Percentage Surface Microhardness Recovery of Test Dentifrices Relative to Placebo Dentifrice

  Surface microhardness recovery (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 demineralization challenge (D1) using formula: \[(D1-R)/ (D1-B)\]\*100.

  Baseline to 4 hours

Secondary Outcomes (3)

• %SMHR of Enamel Specimens Exposed to Test Treatments

  Baseline to 4 hours

• Percent Net Acid Resistance (%NAR) of Enamel Specimens

  Baseline to 4 hours

• Enamel Fluoride Uptake

  Baseline to 4 hours

Study Arms (4)

Fluoride free toothpaste

PLACEBO COMPARATOR

toothpaste with no fluoride

Drug: Placebo

1426ppm Fluoride Toothpaste

EXPERIMENTAL

Experimental toothpaste containing 1426 ppm Fluoride

Drug: Fluoride

1000 ppm Fluoride Toothpaste

EXPERIMENTAL

Experimental toothpaste containing 1000 ppm Fluoride

Drug: Fluoride

500 ppm Toothpaste

EXPERIMENTAL

Experimental toothpaste containing 500 ppm Fluoride

Drug: Fluoride

Interventions

Fluoride DRUG

Fluoride Toothpaste

1000 ppm Fluoride Toothpaste; 1426ppm Fluoride Toothpaste; 500 ppm Toothpaste

Placebo DRUG

Fluoride free toothpaste

Fluoride free toothpaste

Eligibility Criteria

• Age: 11 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy males and females aged 11 to 14 inclusive who have an unstimulated salivary flow rate of at least 0.2 mL/minute and a stimulated salivary flow rate of at least 0.8 mL/minute (Screening Visit 1).

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

Indiana University School of Dentistry

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

• Newby EE, Martinez-Mier EA, Hara A, Lippert F, Kelly SA, Fleming N, Butler A, Bosma ML, Zero DT. A randomised clinical study to evaluate experimental children's toothpastes in an in-situ palatal caries model in children aged 11-14 years. Int Dent J. 2013 Dec;63 Suppl 2(Suppl 2):31-8. doi: 10.1111/idj.12073.

  PMID: 24283282 RESULT

MeSH Terms

Conditions

Dental Caries

Interventions

Fluorides

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Anions; Ions; Electrolytes; Inorganic Chemicals; Hydrofluoric Acid; Fluorine Compounds

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 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2012
• First Posted: May 30, 2012
• Study Start: February 1, 2012
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: August 11, 2014
• Results First Posted: August 26, 2013

Record last verified: 2014-07

Locations

US (1)