Enamel Remineralization Potential of Dentifrices in Situ

Phase 4

Completed

• Conditions: Dental Caries
• Interventions: Drug: NaF; Drug: SnF; Drug: NaMFP

• Registration Number: NCT01128946
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Study First Submitted: 2010-05-20
• Study First Submitted QC: 2010-05-21
• Study First Posted: 2010-05-24
• Results First Submitted: 2013-03-21
• Results First Submitted QC: 2013-08-29
• Results First Posted: 2013-11-03
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-11
• Last Update Posted: 2015-01-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Fluoride Toothpaste 1	NaF	Fluoride toothpaste containing sodium fluoride (NaF)
Fluoride Toothpaste 2	NaF	Fluoride toothpaste containing stannous fluoride (SnF) and NaF.
Fluoride Toothpaste 2	SnF	Fluoride toothpaste containing stannous fluoride (SnF) and NaF.
Fluoride Toothpaste 3	NaF	Fluoride toothpaste containing sodium monofluorophosphate (NaMFP) and NaF.
Fluoride Toothpaste 3	NaMFP	Fluoride toothpaste containing sodium monofluorophosphate (NaMFP) and NaF.
Reference Dentifrice	NaF	Low fluoride toothpaste containing NaF

Primary Outcome Measures

Name	Time	Method
Percentage Surface Microhardness Recovery (%SMHR) of Enamel Specimens Exposed to NaF Toothpaste (1450ppmF) and SnF/NaF Toothpaste (1450ppmF)	Baseline to 14 days	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.

Secondary Outcome Measures

Name	Time	Method
%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	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.
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	Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on the amount of fluoride (F) divided by the area of the enamel cores. The difference between treatments was calculated with respect to fluoride uptake by enamel.

Trial Locations

Locations (1)

Indiana University School of Dentistry; 🇺🇸 Indianapolis, Indiana, United States