NCT07414173 6-month Clinical Investigation Assessing the Efficacy of an Antimicrobial Mouthrinse in Reducing Established Plaque and Improving Gum Health
| NCT ID | NCT07414173 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Colgate Palmolive |
| Condition | Gingivitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2026-01-28 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 90 participants in total. It began in 2026-01-28 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Eva-Maria Axmann
PRINCIPAL INVESTIGATOR
SGS proderm GmbH
Frequently Asked Questions
Who can join the NCT07414173 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Gingivitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07414173 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07414173 currently recruiting?
Yes, NCT07414173 is actively recruiting participants. Visit ClinicalTrials.gov or contact Colgate Palmolive to inquire about joining.
Where is the NCT07414173 trial being conducted?
This trial is being conducted at Schenefeld, Germany.
Who is sponsoring the NCT07414173 clinical trial?
NCT07414173 is sponsored by Colgate Palmolive. The principal investigator is Eva-Maria Axmann at SGS proderm GmbH. The trial plans to enroll 90 participants.