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NCT Number: NCT07414173

6-month Clinical Investigation Assessing the Efficacy of an Antimicrobial Mouthrinse in Reducing Established Plaque and Improving Gum Health

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.

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Key information

Conditions

Gingivitis Dental Plaque Accumulation Gingival Diseases Infections Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Test Mouthrinse

Other

Test Mouthrinse: 0.0553% NaF (250 ppm Fluoride), Amine and 0.2% Zinc Lactate dihydrate

Control Mouthrinse

Other

Control Mouthrinse: 0.0553% NaF(250 ppm Fluoride)

Primary outcomes

  1. Improvement of gum health as measured by the Gingival Index (Löe 1967) between the study groups.

    Time frame: 6-month period

    Four areas of the tooth (buccal, lingual, mesial, and distal surfaces) will be assessed. Each site is assigned a score from 0 to 3 based on clinical observation: 0 indicates normal gingiva and 3 denotes severe inflammation with marked redness, edema, ulceration, and a tendency toward spontaneous bleeding.

Secondary outcomes

  1. Plaque scores as measured by the Plaque Index (Turesky et al. 1970) between the study groups

    Time frame: 6-month period

    The index will quantify dental plaque accumulation by assessing the facial and lingual surfaces of all teeth, typically excluding third molars. Using a disclosing solution to make the bacterial biofilm visible, the examiner will assign a score from 0 to 5 to each surface based on the extent of coverage: 0 indicates no plaque and 5 indicates plaque covering more than two-thirds of the tooth surface.

Sponsors and collaborators

Lead sponsor

Colgate Palmolive

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 17, 2026
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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