Evaluation of Oral Hygiene Products in an In Situ Caries Model

NCT02399163 | Completed Results

• 1 other identifier: 203160
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The study will evaluate and compare the potential anti-caries efficacy of a test regimen: placebo (fluoride free) toothpaste (twice daily use) plus fluoride mouthwash (once daily use), in comparison with brushing with a placebo toothpaste alone (twice daily use), to remineralize previously demineralized enamel specimens, as measured by Surface MicroHardness Recovery (%SMHR). This will be a single center, randomized, laboratory analyst blinded, placebo, four treatment, cross-over study in healthy participants. Participants will be assessed at baseline and at the beginning and end of each treatment visit to monitor clinical efficacy and safety.

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (1)

• Percentage Surface Microhardness Recovery (%SMHR) of Placebo Dentifrice/Fluoride Rinse Compared to Placebo Dentifrice/No Rinse

  SMHR test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was performed ex-vivo and 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. % SMH recovery was calculated from indentation length (micrometer \[μm\]) of sound enamel specimen at baseline(B), indentation length (μm) after in vitro demineralization(D1), indentation length (μm) after intra-oral exposure (R): \[D1-R/D1-B\]\*100.

  Baseline to 14 days

Secondary Outcomes (4)

• Percentage Surface Microhardness Recovery (SMHR) of Placebo Dentifrice/Fluoride Rinse, Placebo Dentifrice/No Rinse, Fluoride Dentifrice/No Rinse and Fluoride Dentifrice/Fluoride Rinse

  Baseline to 14 days

• Enamel Fluoride Uptake

  Baseline to 14 days

• Change in Saliva Fluoride Concentration From Baseline (Pre-treatment) to Day 14

  Baseline to Day14

• Change in Saliva Fluoride Concentration From Baseline (Post-treatment) to Day 14

  Baseline up to Day 14

Study Arms (4)

Placebo dentifrice/Fluoride rinse

EXPERIMENTAL

Twice daily brushing with a non-fluoride (placebo) toothpaste followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride

Drug: Fluoride free toothpaste; Drug: Fluoride mouthwash

Placebo dentifrice/No rinse

PLACEBO COMPARATOR

Twice daily brushing with a non-fluoride (placebo) toothpaste

Drug: Fluoride free toothpaste

Fluoride dentifrice/No rinse

ACTIVE COMPARATOR

Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride

Drug: Fluoride toothpaste

Fluoride dentifrice/Fluoride rinse

EXPERIMENTAL

Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride, followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride.

Drug: Fluoride toothpaste; Drug: Fluoride mouthwash

Interventions

Fluoride free toothpaste DRUG

Brushing with fluoride free toothpaste

Placebo dentifrice/Fluoride rinse; Placebo dentifrice/No rinse

Fluoride toothpaste DRUG

Brushing with fluoride containing toothpaste

Fluoride dentifrice/Fluoride rinse; Fluoride dentifrice/No rinse

Fluoride mouthwash DRUG

Fluoride mouth wash to be followed after brushing with fluoride free toothpaste in "Placebo dentifrice/Fluoride rinse" arm and in "Fluoride dentifrice/Fluoride rinse" arm

Fluoride dentifrice/Fluoride rinse; Placebo dentifrice/Fluoride rinse

Eligibility Criteria

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

You may qualify if:

• Aged between 18 and 85 years inclusive
• Understands and is willing, able and likely to comply with all study procedures and restrictions
• Good general and mental health with, in the opinion of the investigator or medically qualified designee:
• No clinically significant and relevant abnormalities in medical history or upon oral examination.
• Absence of any condition that could affect the participant's safety or well-being or their ability to understand and follow study procedures and requirements
• Currently living in the Indianapolis, Indiana area and has not had a professional fluoride treatment within 14 days of the first treatment visit
• Currently wearing a removable mandibular partial denture with sufficient room in one posterior buccal flange areas to accommodate two enamel specimens
• Willing to have their denture modified to accommodate enamel test specimens and willing and capable of wearing their removable mandibular partial dentures 24 hours per day during the experimental periods
• Have a salivary flow rate in the range of normal values (un-stimulated whole saliva flow rate ≥ 0.2 milliliter (mL)/minute; gum base stimulated whole saliva flow rate ≥ 0.8 mL/minute).

You may not qualify if:

• Pregnant or breast feeding women
• Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
• Currently taking antibiotics or have taken antibiotics in the two weeks prior to the screening visit.
• Taking or have taken a bisphosphonate drug for treatment of osteoporosis.
• Participation in another GSKCH investigational dental product study within seven days of first study treatment.
• Previous participation in this study.
• Recent history (within the last year) of alcohol or other substance abuse.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

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: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2015
• First Posted: March 26, 2015
• Study Start: April 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: August 1, 2015
• Last Updated: May 12, 2016
• Results First Posted: May 12, 2016

Record last verified: 2016-04

Locations

US (1)