Effect of Fluoride in a Dentifrice on Remineralization of Erosive Lesions

NCT01641237 | Completed Phase 3 Results

• 1 other identifier: RH01299
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study will evaluate the performance of fluoride delivered from a new dentifrice formulation without potassium nitrate. It will also evaluate the dose-response to fluoride by testing four dentifrices covering a range of sodium fluoride concentration.

Conditions

Enamel Erosion

Outcome Measures

Primary Outcomes (1)

• Percentage Surface Microhardness Recovery (%SMHR) Dose Response Relationship

  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 erosive challenge (E1) using formula: \[(E1-R)/ (E1-B)\]\*100.

  Baseline to 4 hours

Secondary Outcomes (3)

• %SMHR

  Baseline to 4 hours

• Percentage Relative Erosion Resistance

  Baseline to 4 hours

• Enamel Fluoride Uptake (Corrected Data)

  Baseline to 4 hours

Study Arms (4)

Low ppm fluoride dentifrice

EXPERIMENTAL

Low ppm fluoride as sodium fluoride in a silica base dentifrice

Drug: sodium fluoride

Medium ppm fluoride dentifrice

EXPERIMENTAL

Medium ppm fluoride as sodium fluoride in a silica base dentifrice

Drug: sodium fluoride

High ppm fluoride dentifrice

EXPERIMENTAL

High ppm fluoride as sodium fluoride in a silica base dentifrice

Drug: sodium fluoride

No fluoride dentifrice

PLACEBO COMPARATOR

no added fluoride in a silica base dentifrice

Drug: no added fluoride in a silica base

Interventions

sodium fluoride DRUG

fluoride as sodium fluoride

High ppm fluoride dentifrice; Low ppm fluoride dentifrice; Medium ppm fluoride dentifrice

no added fluoride in a silica base DRUG

no added fluoride

No fluoride dentifrice

Eligibility Criteria

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

You may qualify if:

• intact maxillary dental arch suitable to retain a palatal appliance, an intact mandibular dental arch and a stimulated/unstimulated saliva flow rate of ≥ 0.8 milliliter/minute (ml/min) and ≥ 0.2 ml/min respectively.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

Indiana University School of Dentistry

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Interventions

Sodium Fluoride

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 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2012
• First Posted: July 16, 2012
• Study Start: March 1, 2012
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: July 24, 2014
• Results First Posted: July 31, 2013

Record last verified: 2014-06

Locations

US (1)