Gingivitis
Conditions
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.
Interventions
DRUGAmine/zinc lactate/fluoride system
Amine/zinc lactate/fluoride system (250 ppm F), meridol®, Colgate-Palmolive
DRUGnegative control
Sodium fluoride mouthwash 250 ppm
Sponsors
Colgate Palmolive
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
Countries
Germany
Outcome results
None listed