BridgeMD
New treatment option for Dental Plaque Accumulation
Official title 4-day Plaque Accumulation Model Evaluating Compound Containing Gum
ClinicalTrials.gov ID: NCT06984744
What this study is testing
- What it's testing
- This will be a single-blind, single-center, 3-way crossover, randomized controlled clinical trial with 3 treatment periods utilizing 32 subjects. (Fig 1, in protocol) Each treatment period will be 4 days (96 hours +/-3 hours) in accordance with the plaque accumulation model using one of the following treatment groups: an active compound MIIP-E2 gum (experimental regimen), an inactive compound gum (negative control regimen), and a no-gum (control regimen).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- Adult people between 18 and 65 years old
- Willing to read and sign the IRB-approved informed consent.
- Healthy, as determined by pertinent medical history at the study 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...
- PLI of 2 or greater (Based on the Turesky modification of the Quigley and Hein Plaque Index) calculation based on a whole mouth plaque score.
You likely can't join if
- Presence of any acute or chronic condition, organ system disease, or medication that, in the principal investigator's opinion, could compromise the...
- 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
- Use of antibiotics 30 days prior to or during the study
- Requiring the need for antibiotic premedication prior to dental procedures
- Sensitivity to bovine products (lactoferrin) or any of the listed inactive ingredients
See the full eligibility criteria
- Adult people between 18 and 65 years old
- Willing to read and sign the IRB-approved informed consent.
- Healthy, as determined by pertinent medical history at the study 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...
- PLI of 2 or greater (Based on the Turesky modification of the Quigley and Hein Plaque Index) calculation based on a whole mouth plaque score.
- Willing to comply with the study procedures.
- Presence of any acute or chronic condition, organ system disease, or medication that, in the principal investigator's opinion, could compromise the people' ability to participate in the study.
- 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
- Use of antibiotics 30 days prior to or during the study
- Requiring the need for antibiotic premedication prior to dental procedures
- Sensitivity to bovine products (lactoferrin) or any of the listed inactive ingredients
- Orthodontic appliances or any removable, except lingual bar retainers
- Self-reported pregnant, wanting to get pregnant, or breast-feeding female,
- Self-reported allergy to disclosing solution ingredients (red dye #28)
- Acute Temporomandibular Disorders (TMD)
- Subject who has participated in other studies (including non-medicinal studies) involving product(s) within 30 days before study screening.
- Subject who has previously been assigned by chance in this study
- An employee of the study site directly involved with the study
The study team makes the final eligibility decision.
Where it's taking place
- Indianapolis, Indiana, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Indianapolis, Indiana, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.