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Behavioural Intervention

Brushing + Flossing for Gum Disease

N/A
Recruiting
Led By Ana G Gossweiler, DDS/MSD
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
A minimum of 20 natural teeth (excluding third molars) with at least two scorable surfaces per tooth
Female and Male subjects between 18 to 65 years old
Must not have
Gross oral pathologies, including caries, calculus, or soft tissue conditions that show evidence of chronic neglect
Evidence of acute periodontal conditions or periodontitis with pockets greater than 5 mm on more than one site
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 30 days examination

Summary

This trial will test the effectiveness and safety of a stretchable floss called Floss Loops in reducing gum disease and removing plaque. The trial will involve two groups - one that does not floss

Who is the study for?
This trial is for individuals with gum disease or dental plaque. Participants should be willing to follow the assigned oral hygiene routine for about a month. Specific details on who can join are not provided, but typically, trials exclude those with health conditions that could interfere with results.
What is being tested?
The study compares two groups: one will only brush their teeth and the other will use both brushing and Floss Loops stretchable floss. It's designed to see if adding flossing makes a difference in reducing gum disease and plaque over thirty days.
What are the potential side effects?
While side effects are not detailed here, typical concerns when using new dental products may include discomfort while flossing, potential irritation of the gums, or an allergic reaction to product materials.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have at least 20 natural teeth, not counting wisdom teeth, with two surfaces that can be examined on each.
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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have severe untreated dental or gum problems.
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I have severe gum disease with deep pockets.
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I have a recent jaw joint disorder.
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I have been on antibiotics for 2 weeks and will continue during the study.
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I work on the study team for this clinical trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 30 days examination
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 30 days examination for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Dental Plaque Assessment
Gingivitis Assessment
Secondary study objectives
Bleeding on Marginal Probing (BOMP)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm 1Experimental Treatment1 Intervention
Brushing and Flossing
Group II: Arm 2Placebo Group1 Intervention
Brushing only

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Who is running the clinical trial?

Indiana UniversityLead Sponsor
1,045 Previous Clinical Trials
1,316,820 Total Patients Enrolled
Ana G Gossweiler, DDS/MSDPrincipal InvestigatorIndiana University School of dentistry, Oral Health Research Institute
~21 spots leftby Jan 2025
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