Anti-gingivitis Mouthrinse

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Investigation to Assess the Efficacy of an Antimicrobial Mouthrinse in the Reduction of Established Plaque and Gingivitis: a 6-month Clinical Study

Conditions
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Gingivitis

Intervention / Treatment
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* Drug: Amine/zinc lactate/fluoride system
* Drug: negative control


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mouthwash Test<br> | Drug: Amine/zinc lactate/fluoride system<br>* Amine/zinc lactate/fluoride system (250 ppm F), meridol®, Colgate-Palmolive<br>|
| Experimental: Mouthwash Experimental<br> | Drug: negative control<br>* Sodium fluoride mouthwash 250 ppm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Whole-mouth Mean Modified Gingival Index (MGI) | Gingivitis, gingival severity and gingival, interproximal scores as measured by the Gingival Index (Löe 1967) as difference from baseline to 24 weeks between the study groups. | Baseline, 3 weeks, 12 weeks, 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Turesky Modification of the Quigley Hein Plaque Index (PI) | Plaque, plaque severity and plaque interproximal scores as measured by the Plaque Index (Turesky et al. 1970) as difference from baseline to 24 weeks between the study groups and at each time-point. | Baseline, 3 weeks, 12 weeks, 24 weeks | 
| Intraoral scans | Quantitative changes & before/after imagery from intraoral scans | Baseline, 3 weeks, 12 weeks, 24 weeks | 
| Patient-reported experiences | Changes in participant-reported experience as determined through participant-questionnaire | Baseline, 3 weeks, 12 weeks, 24 weeks |