Gingivitis
Conditions
Brief summary
The objective of this six-month clinical research study is to evaluate the clinical efficacy of a new mouthwash on helping prevent gum problems (gingival index scores ) in adults as compared to a control mouthwash.
Interventions
DRUGCetylpyridinium Chloride, Zinc Lactate and Hyaluronic Acid Mouthwash
0 .075 % cetylpyridinium chloride and 0 .28 % zinc lactate
DRUGPhosFlur Mouthwash
0 .044 % sodium fluoride
Sponsors
Colgate Palmolive
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
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 two dental implants (2 different quadrants ), each implant must have a restoration. * Initial mucositis index of at least 1 .0 as determined by the use of the Mombelli Modified Gingival Index. * Initial plaque index of at least 1 .5 as determined by the use of the Mombelli Modified Plaque Index. * Signed Informed Consent Form.
Exclusion criteria
* Presence of orthodontic bands. * Tumor (s ) of the soft or hard tissues of the oral cavity. * Advanced periodontal disease (purulent exudate, tooth mobility, and /or extensive loss of periodontal attachment or alveolar bone ) or peri-implantitis. * Five or more carious lesions requiring immediate restorative treatment. * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mombelli Modified Gingival Index | baseline | Initial mucositis index of at least 1.0 as determined by the use of the Mombelli Modified Gingival |
| Mombelli Modified Plaque Index | baseline | Initial plaque index of at least 1 .5 as determined by the use of the Mombelli Modified Plaque |
Countries
Italy
Outcome results
None listed