You are viewing an inactive listing

This listing is not currently available. You can either be notified when it becomes available or browse nearby active listings below.

Click here to view additional nearby listings or search by keyword.

Fort Wayne, Indiana 46825

  • Healthy

Purpose:

The purpose of this study is to evaluate the efficacy of brushing, flossing, and rinsing with an alcohol containing essential oil mouth rinse; brushing and flossing; versus brushing and rinsing with an alcohol containing essential oil mouth rinse; and brushing only for the prevention and reduction of plaque and gingivitis.


Criteria:

Inclusion Criteria: - Able to read and understand (participants capable of reading the documents) - Adequate oral hygiene (that is brush teeth daily and exhibit no signs of oral neglect) - Negative pregnancy urine tests (females of childbearing potential only) - Females of childbearing potential must be using a medically-acceptable method of birth control for at least one month prior to Visit 1 and agree to continue using this method during their participation in the study - A minimum of 20 natural teeth with scorable facial and lingual surfaces. Teeth that are grossly carious, extensively restored, orthodontically banded, abutments, exhibiting severe generalized cervical and/or enamel abrasion, or third molars will not be included in the tooth count - A minimum of 10 percent (%) bleeding sites based on the expanded bleeding index (BI) - Participants will have evidence of some gingivitis; there will be no minimum or maximum mean MGI score for gingivitis or TPI score for plaque; mild to severe gingivitis and mild to moderate periodontitis - No more than 3 sites having pocket depths of 5 millimeter (mm) and no sites that are greater than 5 mm in depth Exclusion Criteria: - History of significant adverse effects, including sensitivities or suspected allergies, following use of oral hygiene products such as toothpastes, mouth rinses and red food dye; Known allergy or sensitivity or history of significant adverse effects to any of the investigational product and/or product ingredients (or other ingredients in the products) - Dental prophylaxis within four weeks prior to Screening/Baseline visit - History of medical conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures - Use of antibiotics, anti-inflammatory or anticoagulant therapy during the study or within the one month prior to the Baseline exam. Intermittent use of certain anti-inflammatory medication is acceptable at the discretion of the investigator - Suspected alcohol or substance abuse (example., amphetamines, benzodiazepines, cocaine, marijuana, opiates


NCT ID:

NCT04750005


Primary Contact:

Principal Investigator
Jeffery Milleman, DDS
Salus Research, Inc.


Backup Contact:

N/A


Location Contact:

Fort Wayne, Indiana 46825
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 22, 2021

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.