BridgeMD
Tests treatment safety and results for Gingivitis
Official title 6-month Clinical Investigation Assessing the Efficacy of an Antimicrobial Mouthrinse in Reducing Established Plaque and Improving Gum Health
ClinicalTrials.gov ID: NCT07414173
What this study is testing
- What it's testing
- The goal of this clinical trial is to evaluate the clinical efficacy of an antimicrobial mouthrinse, with a particular focus on its effect on established plaque and the improvement of gum health. Participants will: Brush and rinse twice a day with the designated products for 6 months Visit the clinic once every 3 months after baseline for reassessment.
- 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 to 70. Healthy volunteers may be eligible.
You may be able to join if
- Male and female people aged 18-70 years, inclusive.
- Availability for the 6-month duration of the clinical research study.
- Good general health based on the opinion of the study investigator.
- Signed Informed Consent Form.
- Minimum of 20 natural teeth (excluding third molars).
You likely can't join if
- Be under orthodontic treatment.
- Presence of partial removable dentures.
- Tumor(s) of the soft or hard tissues of the oral cavity.
- Participants with current moderate or severe periodontitis (periodontitis screening index [PSI] \>2 in more than 2 sextants or PSI \>3), and/or...
- Five or more carious lesions requiring immediate restorative treatment.
- Antibiotic use any time during the one-month period prior to entry into the study.
See the full eligibility criteria
- Male and female people aged 18-70 years, inclusive.
- Availability for the 6-month duration of the clinical research study.
- Good general health based on the opinion of the study investigator.
- Signed Informed Consent Form.
- Minimum of 20 natural teeth (excluding third molars).
- Initial gingivitis index of at least 1.5 as determined by the use of the Loe and Silness Gingival Index.
- Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification).
- Be under orthodontic treatment.
- Presence of partial removable dentures.
- Tumor(s) of the soft or hard tissues of the oral cavity.
- Participants with current moderate or severe periodontitis (periodontitis screening index [PSI] \>2 in more than 2 sextants or PSI \>3), and/or purulent exudate, tooth mobility, and/or extensive loss of periodontal...
- Five or more carious lesions requiring immediate restorative treatment.
- Antibiotic use any time during the one-month period prior to entry into the study.
- Participation in any other clinical study or test panel within the one month prior to entry into the study.
- Dental prophylaxis during the past two weeks prior to baseline examinations.
- History of allergies to oral care/personal care consumer products or their ingredients.
- On any prescription medicines that might interfere with the study outcome based on the examiner/PI opinion.
- An existing medical condition that prohibits eating and/or drinking for periods up to 4 hours.
- History of alcohol and/or drug abuse.
- Self-reported pregnancy and/or lactating people.
- people with other oral diseases (including gingival hyperplasia, diseases of the oral mucosa), or any condition that the dental examiner considers exclusionary from the study.
- Smokers or/and users of tobacco products.
- Enrolled in an undergraduate, postgraduate, or academic dentistry program
The study team makes the final eligibility decision.
Where it's taking place
- Schenefeld, Germany
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 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Schenefeld, Germany. 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.