6-month test of an antimicrobial mouthrinse to reduce plaque and improve gum health

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

This 6-month test will see if an antimicrobial mouthrinse, used twice daily, reduces established plaque and improves gum health in adults with gingivitis.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Colgate Palmolive (Industry-sponsored)
• Locations: 1 site (Schenefeld)
• Trial ID: NCT07414173 on ClinicalTrials.gov

What this trial studies

This phase 4 interventional trial compares a test antimicrobial mouthrinse with a control mouthrinse in adults with gingivitis who will brush and rinse twice daily for six months. Clinical visits occur at baseline and every three months for reassessment of plaque (Quigley and Hein Plaque Index, Turesky modification) and gingival status (Loe and Silness Gingival Index). Eligible participants are generally healthy adults 18–70 with at least 20 natural teeth and minimum baseline plaque and gingivitis indices of 1.5, while those with moderate to severe periodontitis, removable partial dentures, or orthodontic appliances are excluded. The trial is sponsored by Colgate-Palmolive and conducted at SGS proderm GmbH in Schenefeld, Germany.

Who should consider this trial

Good fit: Adults 18–70 who are generally healthy, have at least 20 natural teeth, and have measurable gingivitis and plaque indices of 1.5 or higher are the intended participants.

Not a fit: People with moderate or severe periodontitis, extensive periodontal attachment loss, removable partial dentures, active oral tumors, or those undergoing orthodontic treatment are unlikely to benefit from this intervention in the trial.

Why it matters

Potential benefit: If successful, the mouthrinse could reduce established plaque and lower gum inflammation and bleeding associated with gingivitis.

How similar studies have performed: Previous trials of antimicrobial mouthrinses (for example chlorhexidine or cetylpyridinium formulations) have demonstrated short-term reductions in plaque and gingivitis, though long-term comparative benefits vary.

Eligibility criteria

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

Where this trial is running

Schenefeld

• SGS proderm GmbH — Schenefeld, Germany (Recruiting)

Study contacts

• Principal investigator: Eva-Maria Axmann — SGS proderm GmbH

Conditions Gingivitis; Dental Plaque Accumulation