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80 Participants NeededMy employer runs this trial

Electric Flosser for Gum Disease

JL
Overseen ByJeffery L. Milleman, DDS, MPA
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Flaus, Inc
Must not be taking: Anti-inflammatories, Anticoagulants, Immunosuppressants, others
Disqualifiers: Serious medical conditions, Pregnancy, Tobacco use, others

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a study to evaluate the safety and the efficacy of an electric flosser (interproximal cleaning aid), when used with a manual toothbrush, on gingivitis and dental plaque removal.

Are You a Good Fit for This Trial?

This trial is for people with gum disease, gingivitis, or dental plaque who want to improve their oral health. Participants should not have conditions that would prevent them from safely using a toothbrush or flosser.

Inclusion Criteria

At baseline visit, presents with a mean proximal plaque index score ≥ 0.6 according to the Rustogi Modified Navy Plaque Index following an 8 to 12-hour plaque accumulation period
Provide a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed
Willing to use only the test products provided during the 30-day study
See 12 more

Exclusion Criteria

Employee of the investigational site or immediate family member or supervised by the investigator
Daily wear of a night guard or device for bruxism or TMJ disorder
Participation in any study involving oral care products concurrently or within 30 days of baseline exams
See 14 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 visit
1 visit (in-person)

Washout

Participants undergo a 7 to 14-day washout period using only a provided manual toothbrush and toothpaste

1-2 weeks

Treatment

Participants are assigned to either the control group (manual brushing) or the investigational group (electric flosser + brushing) for a 30-day period

4 weeks
3 visits (in-person) at Baseline, Day 15, and Day 30

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Electric Flosser
  • Manual Toothbrush

Trial Overview

The study compares the safety and effectiveness of an electric flosser used alongside a manual toothbrush versus just using a manual toothbrush in reducing gum inflammation and dental plaque.

How Is the Trial Designed?

2

Treatment groups

Active Control

Placebo Group

Group I: Test GroupActive Control2 Interventions
Group II: Manual Toothbrush Control GroupPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Flaus, Inc

Lead Sponsor

Salus Research, Inc., 1220 Medical Park Dr. A, Fort Wayne ID 46825

Collaborator

Trials
1
Recruited
40+

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