Evaluation of Efficacy of Experimental Gel to Foam Dentifrices in Dental Erosion

NCT01657903 | Completed Results

• 1 other identifier: Z6961385
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare and evaluate the ability of two European Union (EU) regulated gel to foam toothpaste formulations versus a non-fluoride toothpaste using a modified in-situ model of dental erosion and remineralization. A positive control i.e fluoride containing toothpaste marketed in EU will also be compared to non-fluoride toothpaste.

Conditions

Dental Erosion; Acid Wear

Outcome Measures

Primary Outcomes (2)

• Relative Erosion Resistance (RER) of Enamel Specimens Post 4 Hours of Treatment Exposure

  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 RER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent RER was calculated by formula: \[(E1-E2)/ (E1-B)\]\*100. Smaller the negative RER, better is treatment regimen in imparting resistance to enamel.

  Baseline, 4 hours post treatment in each treatment period

• Surface Microhardness (SMH) Recovery of Enamel Specimens Post 4 Hours of Treatment Exposure

  SMH test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH 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 SMH recovery 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. A higher percentage values indicate a better outcome.

  Baseline, 4 hours post treatment in each treatment period

Other Outcomes (2)

• RER of Enamel Specimens Post 2 Hours of Treatment Exposure

  Baseline, 2 hours post treatment in each treatment period

• SMH Recovery of Enamel Specimens Post 2 Hours of Treatment Exposure

  Baseline, 2 hours post treatment in each treatment period

Study Arms (4)

NaF/KNO3 toothpaste, Low RDA

EXPERIMENTAL

Participants to brush with 1.5 g of low RDA gel to foam toothpaste containing 1450 ppm F - EU level as NaF. All study treatments contain 5% weight by weight (w/w) KNO3.

Drug: Sodium Fluoride; Drug: Potassium nitrate

NaF/KNO3 toothpaste, Medium RDA

EXPERIMENTAL

Participants to brush with 1.5 g of medium RDA gel to foam toothpaste containing 1450 ppm F - EU level as NaF. All study treatments contain 5% w/w KNO3.

Drug: Sodium Fluoride; Drug: Potassium nitrate

NaF/KNO3 toothpaste

ACTIVE COMPARATOR

Participants to brush with 1.5 g of NaF/KNO3 toothpaste containing 1450 ppm F - EU level as NaF. All study treatments contain 5% w/w KNO3.

Drug: Sodium Fluoride; Drug: Potassium nitrate

No fluoride/KNO3 toothpaste

PLACEBO COMPARATOR

Participants to brush with a fluoride free toothpaste (0 ppmF). All study treatments contain 5% w/w KNO3.

Drug: Potassium nitrate

Interventions

Sodium Fluoride DRUG

Toothpaste containing 1450 ppm F - EU level as NaF.

NaF/KNO3 toothpaste; NaF/KNO3 toothpaste, Low RDA; NaF/KNO3 toothpaste, Medium RDA

Potassium nitrate DRUG

All study treatments contain 5% w/w KNO3.

NaF/KNO3 toothpaste; NaF/KNO3 toothpaste, Low RDA; NaF/KNO3 toothpaste, Medium RDA; No fluoride/KNO3 toothpaste

Eligibility Criteria

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

You may qualify if:

• General and Oral Health: Good general health with (in the opinion of the investigator) no clinically OST and OHT examinations.
• Oral Requirements:
• 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.
• A gum base stimulated whole saliva flow rate ≥ 0.8 g/min and an unstimulated whole saliva flow rate ≥ 0.2 g/min.
• Contraception: Women of childbearing potential who are, in the opinion of the investigator, practicing a reliable method of contraception.

You may not qualify if:

• Oral Health:
• Current active caries or periodontal disease that may compromise the study or the health of the subjects.
• Lesions of the oral cavity that could interfere with the study evaluations, including severe gingivitis, grossly carious lesions, periodontitis and other severe periodontal disease.
• Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
• Clinical Study/Experimental Medication:
• Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit
• Previous participation in this study
• Substance abuse: Recent history (within the last year) of alcohol or other substance abuse.
• Pregnancy: Women who are pregnant or who are intending to become pregnant over the duration of the study
• Breast-feeding: Women who are breast-feeding

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

Indiana University School of Dentistry

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Tooth Erosion

Interventions

Sodium Fluoride; potassium nitrate

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: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2012
• First Posted: August 6, 2012
• Study Start: November 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: January 26, 2015
• Results First Posted: January 26, 2015

Record last verified: 2014-07

Locations

US (1)