Enamel Remineralization Potential of Dentifrices in Situ

NCT01128946 | Completed Phase 4 Results

• 1 other identifier: T3500690
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

This study will use an oral in-situ caries model to study remineralization of enamel due to the action of different combinations of fluoride salts delivered from dentifrices.

Conditions

Dental Caries

Keywords

Enamel remineralization; Fluoride; caries

Outcome Measures

Primary Outcomes (1)

• Percentage Surface Microhardness Recovery (%SMHR) of Enamel Specimens Exposed to NaF Toothpaste (1450ppmF) and SnF/NaF Toothpaste (1450ppmF)

  SMH test was used to assess mineral status of partially demineralized enamel specimens using 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/demineralization, while decrease in the indentation represents rehardening/ remineralization of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline(B), after intra-oral exposure(R) and after in-vitro demineralization(D) using formula: \[(D-R)/(D-B)\]\*100.

  Baseline to 14 days

Secondary Outcomes (2)

• %SMHR of Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), SnF/NaF Toothpaste (1450ppmF), NaMFP/NaF Toothpaste (1450ppmF) and NaF Toothpaste (675ppmF)

  Baseline to 14 days

• Change From Baseline in Enamel Fluoride Uptake Upon Exposure to NaF Toothpaste (1450ppmF), SnF/NaF Toothpaste (1450ppmF), NaMFP/NaF Toothpaste (1450ppmF) and NaF Toothpaste (675ppmF)

  Baseline to 14 days

Study Arms (4)

Fluoride Toothpaste 1

EXPERIMENTAL

Fluoride toothpaste containing sodium fluoride (NaF)

Drug: NaF

Fluoride Toothpaste 2

EXPERIMENTAL

Fluoride toothpaste containing stannous fluoride (SnF) and NaF.

Drug: NaF; Drug: SnF

Fluoride Toothpaste 3

EXPERIMENTAL

Fluoride toothpaste containing sodium monofluorophosphate (NaMFP) and NaF.

Drug: NaF; Drug: NaMFP

Reference Dentifrice

ACTIVE COMPARATOR

Low fluoride toothpaste containing NaF

Drug: NaF

Interventions

NaF DRUG

Fluoride toothpaste containing sodium fluoride as 1450 parts per million (ppm) F, 675 ppmF, 450 ppmF, 350ppmF.

Fluoride Toothpaste 1; Fluoride Toothpaste 2; Fluoride Toothpaste 3; Reference Dentifrice

SnF DRUG

Fluoride toothpaste containing stannous fluoride (1100 ppmF)

Fluoride Toothpaste 2

NaMFP DRUG

Fluoride toothpaste containing sodium monofluorophosphate (1000 ppmF)

Fluoride Toothpaste 3

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical or oral health.
• No current active caries or periodontal disease that may compromise the study or health of the subject.
• All restorations in a good state of repair
• Currently wearing a removable mandibular partial denture with sufficient room in the posterior buccal flange area to accomodate two enamel specimens required dimensions 12 x 7 mm.
• Willing to have their denture modified to accomodate enamel test specimens
• Willing and capable of wearing removable mandibular partial dentures 24 hours per day during the treatment periods.
• Salivary flow rate in the range of normal values (unstimulated whole saliva flow rate greater than or equal to 0.2 mL/ minute; gum base stimulated whole saliva flow rate greater than or equal to 0.8 mL/minute.

You may not qualify if:

• Individuals currently taking antibiotics, or who have taken antibiotics within 30 days prior to the first treatment visit.
• Current active caries or periodontal disease that may compromise the study or health of the subject.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

Indiana University School of Dentistry

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

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 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2010
• First Posted: May 24, 2010
• Study Start: November 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: January 1, 2015
• Results First Posted: November 4, 2013

Record last verified: 2014-12

Locations

US (1)