Actively Recruiting
6-month Clinical Investigation Assessing the Efficacy of an Antimicrobial Mouthrinse in Reducing Established Plaque and Improving Gum Health
Led by Colgate Palmolive · Updated on 2026-02-17
90
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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.
- 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).
You will not qualify if you...
- Under orthodontic treatment.
- Presence of partial removable dentures.
- Tumor(s) of the soft or hard tissues of the oral cavity.
- Current moderate or severe periodontitis (periodontitis screening index >2 in more than 2 sextants or PSI >3), and/or purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone.
- Five or more carious lesions requiring immediate restorative treatment.
- Antibiotic use within one month prior to study entry.
- Participation in any other clinical study or test panel within one month prior to study entry.
- Dental prophylaxis during the past two weeks prior to baseline examinations.
- History of allergies to oral care or personal care products or their ingredients.
- Use of prescription medicines that might interfere with the study outcome based on investigator opinion.
- Medical conditions that prohibit eating or drinking for up to 4 hours.
- History of alcohol or drug abuse.
- Self-reported pregnancy or lactation.
- Other oral diseases including gingival hyperplasia or diseases of the oral mucosa, or any condition exclusionary by dental examiner.
- Smokers or users of tobacco products.
- Enrollment in an undergraduate, postgraduate, or academic dentistry program.
AI-Screening
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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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