Clinical Study to Investigate a New Mouthwash in Reducing Plaque and Helping Prevent Gum Problems⦠(NCT06770114) | Clinical Trial Compass
CompletedPhase 3
Clinical Study to Investigate a New Mouthwash in Reducing Plaque and Helping Prevent Gum Problems on Dental Implants Over a 6-month Period of Product Use
Italy80 participantsStarted 2021-10-18
Plain-language 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.
Who can participate
Age range18 Years ā 70 Years
SexALL
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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