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

February 10, 2026 updated by: Colgate Palmolive

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Schenefeld, Germany, 22869
        • Recruiting
        • SGS proderm GmbH
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Male and female subjects aged 18-70 years, inclusive.
  2. Availability for the 6-month duration of the clinical research study.
  3. Good general health based on the opinion of the study investigator.
  4. Signed Informed Consent Form.
  5. Minimum of 20 natural teeth (excluding third molars).
  6. Initial gingivitis index of at least 1.5 as determined by the use of the Loe and Silness Gingival Index.
  7. Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification).

Exclusion Criteria:

  1. Be under orthodontic treatment.
  2. Presence of partial removable dentures.
  3. Tumor(s) of the soft or hard tissues of the oral cavity.
  4. 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.
  5. Five or more carious lesions requiring immediate restorative treatment.
  6. Antibiotic use any time during the one-month period prior to entry into the study.
  7. Participation in any other clinical study or test panel within the one month prior to entry into the study.
  8. Dental prophylaxis during the past two weeks prior to baseline examinations.
  9. History of allergies to oral care/personal care consumer products or their ingredients.
  10. On any prescription medicines that might interfere with the study outcome based on the examiner/PI opinion.
  11. An existing medical condition that prohibits eating and/or drinking for periods up to 4 hours.
  12. History of alcohol and/or drug abuse.
  13. Self-reported pregnancy and/or lactating subjects.
  14. 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.
  15. Smokers or/and users of tobacco products.
  16. Enrolled in an undergraduate, postgraduate, or academic dentistry program

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Test Group
Subjects will be instructed to brush their teeth twice daily for two minutes each time with the toothpaste and toothbrush provided. After brushing, subjects will swish with 15 ml of mouthrinse for 30 seconds.
Other: Test Mouthrinse
Test Mouthrinse: 0.0553% NaF (250 ppm Fluoride), Amine and 0.2% Zinc Lactate dihydrate
Placebo Comparator: Control Group
subjects will be instructed to brush their teeth twice daily for two minutes each time with the toothpaste and toothbrush provided. After brushing, subjects will swish with 15 ml of mouthrinse for 30 seconds.
Other: Control Mouthrinse
Control Mouthrinse: 0.0553% NaF(250 ppm Fluoride)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6-month period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6-month period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Colgate Palmolive

Investigators

  • Principal Investigator: Eva-Maria Axmann, SGS proderm GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 28, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

February 2, 2026

First Submitted That Met QC Criteria

February 10, 2026

First Posted (Actual)

February 17, 2026

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 10, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRO-2025-10-PG-MER-MW-ZM

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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