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Clinical Investigation to Assess the Efficacy of an Antimicrobial Mouthrinse in the Reduction of Established Plaque and the Improvement of Gum Health: a 6-month Clinical Study
Led by Colgate Palmolive · Updated on 2026-02-17
90
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial evaluates the effectiveness of an antimicrobial mouthrinse in reducing established dental plaque and improving gum health in adults with gingivitis and dental plaque accumulation. The study focuses on measuring improvements in gum health using the Gingival Index and plaque reduction using the Plaque Index over a six-month period. Participants include adults aged 18 to 70 years who have at least 20 natural teeth and meet specific oral health criteria. Participants are randomly assigned to one of two groups: the test group using a mouthrinse containing 0.0553% sodium fluoride, amine, and 0.2% zinc lactate dihydrate, or the control group using a mouthrinse with 0.0553% sodium fluoride only. Both groups will brush their teeth twice daily with provided toothpaste and toothbrush, then rinse with 15 ml of the assigned mouthrinse for 30 seconds. This routine continues for six months. Throughout the study, participants visit the clinic every three months after the baseline visit for reassessment. Researchers monitor gum health improvements and plaque levels using standardized indices. The study also includes safety monitoring and requires participants to maintain good general health and adhere to the treatment regimen. The total duration of participation is six months, with regular assessments to evaluate treatment effects.
CONDITIONS
Brief Title
6-month Clinical Investigation Assessing the Efficacy of an Antimicrobial Mouthrinse in Reducing Established Plaque and Improving Gum Health
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female subjects aged 18-70 years, inclusive.
- Available to participate for the full 6-month duration of the study.
- Good general health as judged by the study investigator.
- Signed informed consent form.
- Have at least 20 natural teeth, excluding third molars.
- Initial gingivitis index of at least 1.5 using the Loe and Silness Gingival Index.
- Initial plaque index of at least 1.5 using the Quigley and Hein Plaque Index (Turesky Modification).
You will not qualify if you...
- Currently undergoing orthodontic treatment.
- Wearing partial removable dentures.
- Presence of tumors in the soft or hard tissues of the mouth.
- Moderate or severe periodontitis or related severe gum conditions.
- Five or more untreated cavities needing immediate treatment.
- Use of antibiotics within one month before the study.
- Participation in another clinical study within one month before the study.
- Dental cleaning within two weeks prior to baseline examination.
- Allergies to oral or personal care products or ingredients.
- Taking prescription medicines that might affect study results.
- Medical conditions preventing eating or drinking for up to 4 hours.
- History of alcohol or drug abuse.
- Pregnant or breastfeeding.
- Other oral diseases or conditions deemed exclusionary by the dental examiner.
- Use of tobacco products or smoking.
- Enrollment in any dentistry academic program.
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants brush their teeth twice daily with provided toothpaste and toothbrush, then rinse with 15 ml of mouthrinse for 30 seconds after brushing.
Regular visits during the 6-month treatment period
Trial Site Locations
Total: 1 location
1
SGS proderm GmbH
Schenefeld, Germany, 22869
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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