Evaluation of the Fluoride Dose Response of a Modified In Situ Caries Model

NCT03383783 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: 17-I-112208705
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the fluoride dose response of different dentifrice fluoride concentrations - 0, 250, 500 and 1100 ppm fluoride of our existing in situ model involving the use of human enamel specimens placed in the buccal flange area of the subjects partial denture with the modified model involving placement of bovine enamel specimens in a denture tooth location.

Conditions

Caries

Keywords

Caries

Outcome Measures

Primary Outcomes (1)

• Percentage Surface Microhardness Recovery (%SMH)

  The extent of remineralization will be calculated based on the method of \[Gelhard et al., 1979\]. * SMH recovery = (D1-R)/(D1-B) ×100 B = indentation length (µm) of sound enamel specimen at baseline D1 = indentation length (µm) after in vitro demineralization R = indentation length (µm) after intra-oral exposure.

  Enamel specimens will be evaluated after 14 days of intra-oral exposure

Secondary Outcomes (6)

• Net Acid Resistance (NAR)

  Enamel specimens will be evaluated after 14 days of intra-oral exposure

• Comparative Acid Resistance (CAR)

  Enamel specimens will be evaluated after 14 days of intra-oral exposure

• Enamel Fluoride Uptake (EFU)

  Enamel specimens will be evaluated after 14 days of intra-oral exposure

• Transverse Microradiography (TMR) - Integrated Mineral Loss - ∆Z

  Enamel specimens will be evaluated after 14 days of intra-oral exposure

• Transverse Microradiography (TMR) - Lesion Depth - L

  Enamel specimens will be evaluated after 14 days of intra-oral exposure

Study Arms (4)

Treatment Period 1

OTHER

0 ppm F (placebo, negative control), 250 ppm F as NaF (dose-response control), 500 ppm F as NaF (dose-response control), 1100 ppm F as NaF (positive control)

Drug: 0 ppm F (placebo, negative control); Drug: 250 ppm F as NaF (dose-response control); Drug: 500 ppm F as NaF (dose-response control); Drug: 1100 ppm F as NaF (positive control)

Treatment Period 2

OTHER

0 ppm F (placebo, negative control), 250 ppm F as NaF (dose-response control), 500 ppm F as NaF (dose-response control), 1100 ppm F as NaF (positive control)

Drug: 0 ppm F (placebo, negative control); Drug: 250 ppm F as NaF (dose-response control); Drug: 500 ppm F as NaF (dose-response control); Drug: 1100 ppm F as NaF (positive control)

Treatment Period 3

OTHER

0 ppm F (placebo, negative control), 250 ppm F as NaF (dose-response control), 500 ppm F as NaF (dose-response control), 1100 ppm F as NaF (positive control)

Drug: 0 ppm F (placebo, negative control); Drug: 250 ppm F as NaF (dose-response control); Drug: 500 ppm F as NaF (dose-response control); Drug: 1100 ppm F as NaF (positive control)

Treatment Period 4

OTHER

0 ppm F (placebo, negative control), 250 ppm F as NaF (dose-response control), 500 ppm F as NaF (dose-response control), 1100 ppm F as NaF (positive control)

Drug: 0 ppm F (placebo, negative control); Drug: 250 ppm F as NaF (dose-response control); Drug: 500 ppm F as NaF (dose-response control); Drug: 1100 ppm F as NaF (positive control)

Interventions

0 ppm F (placebo, negative control) DRUG

Each subject will use this product during one of the four treatment periods in the crossover study design.

Also known as: Sensodyne sodium fluoride/silica toothpaste base formulation

Treatment Period 1; Treatment Period 2; Treatment Period 3; Treatment Period 4

250 ppm F as NaF (dose-response control) DRUG

Each subject will use this product during one of the four treatment periods in the crossover study design.

Also known as: Sensodyne sodium fluoride/silica toothpaste base formulation

Treatment Period 1; Treatment Period 2; Treatment Period 3; Treatment Period 4

500 ppm F as NaF (dose-response control) DRUG

Each subject will use this product during one of the four treatment periods in the crossover study design.

Also known as: Sensodyne sodium fluoride/silica toothpaste base formulation

Treatment Period 1; Treatment Period 2; Treatment Period 3; Treatment Period 4

1100 ppm F as NaF (positive control) DRUG

Each subject will use this product during one of the four treatment periods in the crossover study design.

Also known as: Sensodyne sodium fluoride/silica toothpaste base formulation

Treatment Period 1; Treatment Period 2; Treatment Period 3; Treatment Period 4

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• provide voluntary, written informed consent;
• be between 18 and 85 years old;
• understand and be willing, able and likely to comply with all study procedures and restrictions;
• be wearing a removable mandibular partial denture with sufficient room in one posterior buccal flange area to accommodate two enamel specimens (required dimensions 12 × 7 mm) and room on the same side to accommodate two 4 mm round specimens in the buccal surface of two posterior denture teeth;
• be willing and capable of wearing their removable partial denture 24 hours a day for four (4), two-week treatment periods;
• be willing to allow study personnel to drill specimen sites (as described #4) in their mandibular partial denture;
• be in good medical and dental health with no active caries or periodontal disease; NOTE; subjects presenting at screening with caries may continue in the study if their carious lesions are restored prior to beginning treatment 1.
• have a salivary flow rate in the range of normal values (unstimulated whole saliva flow rate ≥ 0.2 mL/min; gum base stimulated whole saliva flow rate ≥ 0.8 mL/min).

You may not qualify if:

• currently be pregnant, intending to become pregnant during the study period or breast feeding;
• currently have any medical condition that could be expected to interfere with the subject's safety during the study period;
• currently be taking antibiotics or have taken antibiotics in the two weeks prior to the beginning treatment 1;
• have participated in another clinical study or receipt of an investigational drug within 30 days of beginning treatment 1; or
• be taking fluoride supplements, required to use a fluoride mouthrinse or have received a professional fluoride treatment in the two weeks preceding specimen placement;
• be taking or have ever taken bisphosphonate drugs (e.g., Fosamax, Actonel and Boniva) for the treatment of osteoporosis;

Sponsors & Collaborators

• Domenick Zero: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Indiana University School of Dentistry, Oral Health Research Institute

Indianapolis, Indiana, 46202, United States

Location

Results Point of Contact

• Title: Domenick T Zero, DDS, MS
• Organization: Oral Health Research Institute

dzero@iu.edu

317-274-8822

Study Officials

• Domenick T Zero, DDS, MS

  Indiana University

  PRINCIPAL INVESTIGATOR

• Anderson Hara, DDS, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

• Frank Lippert, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Oral Health Research Institute

Study Record Dates

• First Submitted: December 19, 2017
• First Posted: December 26, 2017
• Study Start: December 19, 2017
• Primary Completion: May 2, 2018
• Study Completion: May 2, 2018
• Last Updated: May 20, 2019
• Results First Posted: May 20, 2019

Record last verified: 2019-05

Locations

US (1)