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New treatment option for Gingivitis
Official title Clinical Study to Collect and Analyze Dental Plaque and Oral Health Measures in a Population With High Plaque/Low Gingivitis and High Plaque/High Gingivitis
ClinicalTrials.gov ID: NCT07614490
What this study is testing
What is sodium monofluorophosphate toothpaste?
sodium monofluorophosphate toothpaste is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for gingivitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The objective of this clinical research study is to collect and analyze plaque and oral health measures in a population with high plaque/low gingivitis and high plaque/high gingivitis
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female volunteers at least 18 years of age and in general good health.
- Willing and able to understand and sign the informed consent form.
- Must have a whole mouth mean TPI score ≥ 3.25
- N=40 must have moderate-severe gingivitis (Whole Mouth Mean MGI≥2.5 or percent bleeding sites based on EBI ≥20%) and N=40 must have mild gingivitis...
- Must have at least two areas in the mouth with high plaque/low inflammation and two areas with high plaque/high inflammation
You likely can't join if
- Medical condition which requires premedication prior to dental visits/procedure.
- Known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredients in the test products as determined by...
- Active disease of the hard oral tissues.
- Significant oral soft tissue pathology, excluding plaque-induced gingivitis.
- people with fixed or removable orthodontic appliances or removable partial dentures.
- Dental prophylaxis within 30 days prior to study start.
See the full eligibility criteria
- Male or female volunteers at least 18 years of age and in general good health.
- Willing and able to understand and sign the informed consent form.
- Must have a whole mouth mean TPI score ≥ 3.25
- N=40 must have moderate-severe gingivitis (Whole Mouth Mean MGI≥2.5 or percent bleeding sites based on EBI ≥20%) and N=40 must have mild gingivitis (Whole Mouth Mean MGI≤2.5 and percent bleeding sites based on EBI\<20%)
- Must have at least two areas in the mouth with high plaque/low inflammation and two areas with high plaque/high inflammation
- Be willing to conform to the study protocol and procedures.
- Minimum of 20 natural teeth with scorable facial and lingual surfaces
- Medical condition which requires premedication prior to dental visits/procedure.
- Known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredients in the test products as determined by the study examiner.
- Active disease of the hard oral tissues.
- Significant oral soft tissue pathology, excluding plaque-induced gingivitis.
- people with fixed or removable orthodontic appliances or removable partial dentures.
- Dental prophylaxis within 30 days prior to study start.
- Use of antibiotics, antimicrobial drugs, anti-inflammatory drugs, or anticoagulant therapies within 30 days prior to study start.
- Use of chemotherapeutic oral care products within two weeks prior to study start.
- Participation in any other clinical study within 30 days prior to enrollment into this study.
- people who must receive dental treatment during the study dates.
- Immunocompromised individuals (HIV, AIDS, immunosuppressive drug therapy).
- Use of smokeless tobacco, vaping, or e-cigarettes or suspected substance abuse.
- Current smokers (if former smoker, should have stopped at least 1 month prior to Visit 1)
- Pregnant or lactating people, or people planning to become pregnant during the course of the study.
- Medical condition which prohibits not eating/drinking or chewing gum for four (4) hours prior to your scheduled visits;
- people who have an infectious disease and/or other blood borne diseases (Hepatitis series, HIV, tuberculosis).
The study team makes the final eligibility decision.
Where it's taking place
- Fort Wayne, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fort Wayne, 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.