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

Colgate-Palmolive

Status and phase: Enrolling; Phase 4

Conditions: Dental Plaque Accumulation; Gingivitis

Treatments: Other: Test Mouthrinse; Other: Control Mouthrinse

Study type: Interventional

Funder types: Industry

Identifiers

NCT07414173

CRO-2025-10-PG-MER-MW-ZM

Details and patient eligibility

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups, including a placebo group

Test Group

Active Comparator group

Description:

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.

Treatment:

Other: Test Mouthrinse

Control Group

Placebo Comparator group

Description:

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.

Treatment:

Other: Control Mouthrinse