Status:
RECRUITING
6-month Clinical Investigation Assessing the Efficacy of an Antimicrobial Mouthrinse in Reducing Established Plaque and Improving Gum Health
Lead Sponsor:
Colgate Palmolive
Conditions:
Gingivitis
Dental Plaque Accumulation
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
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. Par...
Eligibility Criteria
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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 attachment or alveolar bone.
- 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 subjects.
- Subjects 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
Key Trial Info
Start Date :
January 28 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT07414173
Start Date
January 28 2026
End Date
November 1 2026
Last Update
February 17 2026
Active Locations (1)
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1
SGS proderm GmbH
Schenefeld, Germany, 22869