Anti-gingivitis Mouthrinse

Phase 3

Completed

• Conditions: Gingivitis
• Interventions: Drug: Amine/zinc lactate/fluoride system; Drug: negative control

• Registration Number: NCT06048627
• Lead Sponsor: Colgate Palmolive

Brief Summary

The purpose of this study is to prove whether a fluoride/zinc lactate containing mouthrinse is able to reduce dental plaque and gingival inflammation in patients who have gingivitis when applied twice daily during brushing at home over a period of 12 weeks.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-16
• Study First Submitted QC: 2023-09-16
• Study First Posted: 2023-09-21
• Study Start: 2024-03-06
• Status Verified: 2024-04
• Primary Completion: 2024-10-01
• Study Completion: 2024-10-01
• Last Update Submitted: 2025-05-16
• Last Update Posted: 2025-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Availability for the six-month duration of the clinical research study.
• Good general health.
• Minimum of 20 uncrowned permanent natural teeth (excluding third molars).
• Initial gingivitis index of at least 1.5 as determined by the use of the Gingival Index (Löe 1967).
• Initial plaque index of at least 1.5 as determined by the use of the Plaque Index (Turesky et al. 1970).
• Signed Informed Consent Form.

Exclusion Criteria

• Presence of orthodontic bands.
• Malign tumor(s) of the soft or hard tissues of the oral cavity.
• 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.
• An existing medical condition that prohibits eating or drinking for periods up to 4 hours.
• History of alcohol or drug abuse.
• Self-reported pregnant or lactating subjects.
• Participants who have systemic diseases that require regular systemic medication intake that may affect the gingival condition (e.g. antibiotics, phenytoin, nifedipine, cyclosporine, steroids, antiphlogistics).
• Participants who require antibiotic treatments for dental appointments.
• Participants with current moderate or severe chronic or aggressive periodontitis (periodontitis screening index [PSI] >2 in more than 2 sextants or PSI >3).
• Subjects with caries requiring treatment (e.g., caries with cavity) or other oral diseases (including gingival hyperplasia, diseases of the oral mucosa);
• Smokers or/and users of tobacco products.
• Persons, who are unable to give their consent (e.g., persons who have limited legal capacity)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mouthwash Test	Amine/zinc lactate/fluoride system	-
Mouthwash Experimental	negative control	-

Primary Outcome Measures

Name	Time	Method
Whole-mouth Mean Modified Gingival Index (MGI)	Baseline, 3 weeks, 12 weeks, 24 weeks	Gingivitis, gingival severity and gingival, interproximal scores as measured by the Gingival Index as difference from baseline to 24 weeks between the study groups.

Secondary Outcome Measures

Name	Time	Method
Intraoral scans	Baseline, 3 weeks, 12 weeks, 24 weeks	Quantitative changes \& before/after imagery from intraoral scans
Patient-reported experiences	Baseline, 3 weeks, 12 weeks, 24 weeks	Changes in participant-reported experience as determined through participant-questionnaire
Turesky Modification of the Quigley Hein Plaque Index (PI)	Baseline, 3 weeks, 12 weeks, 24 weeks	Plaque, plaque severity and plaque interproximal scores as measured by the Plaque Index as difference from baseline to 24 weeks between the study groups and at each time-point.

Trial Locations

Locations (1)

Technische Universität Dresden; 🇩🇪 Dresden, Germany