Volunteers Needed for Dental Floss Study!
Ana Gossweiler, DDS
Primary Investigator
Brief description of study
Why is this study being done?
The purpose of this study is to test the effectiveness and safety of Floss Loops™ stretchable floss for controlling gingivitis (swelling/bleeding of the gums) and plaque removal from teeth. All products in this study are already marketed, meaning they are not investigational, and you can buy them in a store.
Who can take part?
Adults between 18-65 years of age who have gingivitis.
Additional information
Study title:Evaluation of the efficacy and safety of a loop stretchable dental floss in controlling gingivitis and supragingival plaque removal during thirty days.
The study is being conducted by Dr. Ana Gossweiler of the Indiana University School of Dentistry, Oral Health Research Institute. It is funded by Floss Loops™.
To learn more about Dr. Ana Gossweiler, DDS, MSD, BS and her research interests, please visit this link: https://dentistry.iu.edu/about/directory/gossweiler-ana.html
IU School of Dentistry Oral Health Research Institute (OHRI): https://dentistry.iu.edu/research/oral-health-research-institute/index.html
Detailed description of study
What will happen during the study?
- Day 1 (Screening Visit): You will be asked to attend an in-person screening visit at the Oral Health Research Institute (OHRI) in Indianapolis, IN to see if you may qualify (the screening visit involves an oral exam by a study dentist who will look at the general condition of your mouth; you will be asked to refrain from oral hygiene (OH) procedures the evening before and the morning of the screening visit. Chewing gum 12 hours before the screening visit and from eating or drinking anything 2 hours before oral assessments).
- If you are eligible and choose to participate, you will be randomly assigned, like the flip of a coin, to the control group (brushing twice a day only and no flossing) or to the experimental group (brushing and flossing with the stretchable loop floss twice a day).
- During the study, you will be asked to clean your teeth daily using only the toothbrush provided and an assigned ADA-accepted toothpaste.
- Day 15: You will be asked to complete 1 follow-up phone call with the study staff.
- Day 30: You will be asked to attend 1 additional in-person study visit at the OHRI.
- Compensation will be provided based on eligibility and completion.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: all
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Age: 18 years - 65 years
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Gender: All
Inclusion Criteria:
- Generally healthy (as determined by pertinent medical history at the examiner dentist's discretion)
- A minimum of 20 natural teeth (excluding third molars) with at least two scorable surfaces per tooth (teeth with full crowns, large/extensive restorations on the interproximal areas, and orthodontic bands will not be included in the tooth count)
- Mild to moderate plaque and gingivitis
- Be willing to comply with all study visits and requirements
Exclusion Criteria:
- Presence of any acute or chronic condition, organ system disease, or medication that, in the principal investigator's opinion, could compromise the subjects' ability to participate in the study
- Gross oral pathologies, including caries, calculus, or soft tissue conditions that show evidence of chronic neglect
- Orthodontic appliances or any removable prosthesis
- Evidence of acute periodontal conditions or periodontitis with pockets greater than 5 mm on more than one site
- Taking antibiotics two weeks before baseline procedures
- Need for antibiotic prophylaxis prior to dental procedures
- Use of daily anti-inflammatory drugs (NSAID, TNF- AB, others) within 30 days before baseline
- Pregnant, wanting to get pregnant, or breast-feeding female
- Acute Temporomandibular Disorders (TMD)
- Has participated in other studies (including non-medicinal studies) involving product(s) within 30 days before study entry
- Has previously been randomized in this study
- Self-reported allergy to disclosing solution ingredients (red dye #28)
- An employee of the study site directly involved with the study
