NCT02574221

Brief Summary

This study is to evaluate the sensitivity of the molecular method and its ability to split a stannous fluoride toothpaste versus a negative control.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

October 9, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 12, 2015

Completed
Last Updated

October 6, 2017

Status Verified

October 1, 2017

Enrollment Period

2 months

First QC Date

October 9, 2015

Last Update Submit

October 4, 2017

Conditions

PlaqueGingivitis

Outcome Measures

Primary Outcomes (2)

  • plaque scores

    baseline

  • plaque scores

    week 8

Secondary Outcomes (2)

  • gingivitis score

    baseline

  • gingivitis score

    week 8

Study Arms (2)

stannous fluoride toothpaste

EXPERIMENTAL

brush twice a day for 8 weeks

Drug: stannous fluoride toothpaste

cavity protection toothpaste

SHAM COMPARATOR

brush twice a day for 8 weeks

Drug: cavity protection toothpaste

Interventions

stannous fluoride toothpasteDRUG

0.454% stannous fluoride toothpaste

stannous fluoride toothpaste
cavity protection toothpasteDRUG

0.243% sodium fluoride toothpaste

cavity protection toothpaste

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • In order to be included in the study, each subject must:
  • Provide written informed consent to participate in the study;
  • Be 18 years of age or older;
  • Agree not to participate in any other oral/dental product studies during the course of this study;
  • Agree to delay any elective dentistry (including dental prophylaxis) until the study has been completed;
  • Agree to maintain their current oral hygiene routine between the Screening and Baseline Visit and not to add/change their oral care products during this time;
  • Agree to refrain from any form of non-specified oral hygiene during the treatment periods (after the Baseline Visit), including but not limited to the use of products such as floss or whitening products;
  • Agree to return for all scheduled visits and follow study procedures;
  • Must have at least 16 natural teeth;
  • Be in good general health, as determined by the Investigator/designee based on a review of the health history/update for participation in the study;
  • Agree to refrain from all oral hygiene for at least 12 hours prior to each visit;
  • Agree to refrain from eating, chewing gum, drinking and using tobacco for 4 hours prior to each visit;
  • Have at least 20 bleeding sites (sites with a score of 1 or 2 on the GBI index);
  • Have minimum 3 sampling sites with bleeding and pocket depth ≥3mm but not deeper than 4mm;
  • Have minimum 3 sampling sites without bleeding and with pocket depth ≤2mm.

You may not qualify if:

  • Subjects are excluded from study participation where there is evidence of:
  • Have had a dental prophylaxis within 2 weeks of plaque sampling visits;
  • Have taken antibiotics or used anti-gingivitis / anti-bacterial oral care products such as chlorhexidine or Listerine within 2 weeks of plaque sampling visits;
  • Have rampant caries, open or untreated caries, or advanced periodontitis requiring prompt treatment;
  • Need an antibiotic prophylaxis prior to dental visits;
  • A history of hypersensitivity to oral care products containing stannous fluoride;
  • A history of hypersensitivity to dyes (from products containing food dyes);
  • Present with any disease or condition(s) that could be expected to interfere with examination procedures or the subject's safe completion of the study; or
  • Are pregnant (Self-reported) or lactating.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Salus Research

Fort Wayne, Indiana, 46825, United States

Location

MeSH Terms

Conditions

Plaque, AmyloidGingivitis

Interventions

hydrated silica gel-based toothpaste

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsInfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2015

First Posted

October 12, 2015

Study Start

August 1, 2015

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

October 6, 2017

Record last verified: 2017-10

Locations

US(1)