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

NCT07414173 | Recruiting Phase 4

• 1 other identifier: CRO-2025-10-PG-MER-MW-ZM
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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. 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

Gingivitis; Dental Plaque Accumulation

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (1)

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

  6-month period

Study Arms (2)

Test Group

ACTIVE COMPARATOR

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

Control Group

PLACEBO COMPARATOR

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

Interventions

Test Mouthrinse OTHER

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

Test Group

Control Mouthrinse OTHER

Control Mouthrinse: 0.0553% NaF(250 ppm Fluoride)

Control Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

• 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.
• Smokers or/and users of tobacco products.
• Enrolled in an undergraduate, postgraduate, or academic dentistry program

Sponsors & Collaborators

• Colgate Palmolive: lead

Study Sites (1)

SGS proderm GmbH

Schenefeld, 22869, Germany

RECRUITING

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Eva-Maria Axmann

  SGS proderm GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 17, 2026
• Study Start: January 28, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-01

Locations

DE (1)