Experimental Dentifrice Remineralization/Fluoride Uptake in an in Situ Model

NCT00752089 | Completed Phase 2 Results

• 1 other identifier: Z3120510
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine whether an experimental fluoridated dentifrice is effective in the treatment of dental caries

Conditions

Dental Erosion

Keywords

enamel fluoride uptake; erosion; enamel remineralization

Outcome Measures

Primary Outcomes (1)

• Percentage Surface Micro-hardness Recovery (SMHR) of Enamel Specimens

  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 re-hardening of enamel surface. Percent SMHR 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 (1)

• Adjusted Mean Change From Baseline in Enamel Fluoride Uptake

  Baseline to 14 days

Study Arms (4)

Sodium fluoride/potassium nitrate/Isopentane dentifrice

EXPERIMENTAL

Participants to brush their teeth for one timed minute twice daily with a gel to foam dentifrice containing active ingredients: 1450 ppm F as sodium fluoride (NaF) and 5% potassium nitrate (KNO3) and isopentane as an excipient ingredient.

Drug: NaF/ KNO3/isopentane Dentifrice

NaF/KNO3 Dentifrice

EXPERIMENTAL

Participants to brush their teeth for one timed minute twice daily with a gel to foam dentifrice, containing as active ingredients: 1450 ppm NaF and 5% KNO3 but no isopentane.

Drug: NaF/KNO3 Dentifrice

NaF Dentifrice

ACTIVE COMPARATOR

Participants to brush their teeth for one timed minute twice daily with a dentifrice containing 1450 ppm F as NaF.

Drug: NaF Dentifrice

Placebo Dentifrice

PLACEBO COMPARATOR

Participants to brush their teeth for one timed minute twice daily with a fluoride free dentifrice (0 ppm F).

Other: Placebo Dentifrice

Interventions

NaF/ KNO3/isopentane Dentifrice DRUG

Experimental toothpaste

Sodium fluoride/potassium nitrate/Isopentane dentifrice

NaF/KNO3 Dentifrice DRUG

Experimental toothpaste

NaF/KNO3 Dentifrice

NaF Dentifrice DRUG

Active comparator

NaF Dentifrice

Placebo Dentifrice OTHER

Placebo comparator

Placebo Dentifrice

Eligibility Criteria

• Age: 18 Years - 78 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: Aged between 18 and 78
• Fluoride: Currently living in the Indianapolis area which has a fluoridated water supply (1 ppm F) and not taking fluoride supplements for medical reasons
• Dentures: Currently wearing a removable mandibular partial denture with sufficient room in the posterior buccal flange area to accommodate two enamel specimens (required dimensions 12 x 7 mm). Willing and capable of wearing their removable partial dentures 24 hours per day during the experimental periods
• Dental health:Have no current active caries or periodontal disease that may compromise the study or the health of the participants and all restorations in a good state of repair
• Salivary flow: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
• Compliance: Understands and is willing, able and likely to comply with all study procedures and restrictions
• Consent:Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form
• General Health: Good general health with (in the opinion of the investigator) no clinically significant and/or relevant abnormalities of medical history or oral examination that could interfere with participant safety during the study period

You may not qualify if:

• Antibiotics:Currently taking antibiotics or have taken antibiotics in the two weeks prior to the screening visit
• Allergy/Intolerance:Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
• Pregnancy:Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
• Breast-feeding:Women who are breast-feeding.
• Clinical Study/Experimental Medication: Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit
• Personnel:An employee of the sponsor or the study site who is directly involved in the study

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Tooth Erosion

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Tooth Wear

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
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2008
• First Posted: September 15, 2008
• Study Start: September 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: December 8, 2016
• Results First Posted: December 8, 2016

Record last verified: 2016-05