Status:
COMPLETED
A Study of Mouth Rinses in Type 1 and Type 2 Diabetic Participants
Lead Sponsor:
Johnson & Johnson Consumer Inc. (J&JCI)
Conditions:
Gingivits in Diabetics
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate mouth rinse formulations for oral soft tissue tolerance and efficacy in plaque/ gingivitis prevention/reduction in Type 1 and Type 2 diabetics when used twice ...
Eligibility Criteria
Inclusion
- Adequate oral hygiene (that is brush teeth daily and exhibit no signs of oral neglect)
- Able to comprehend and follow the requirements and restrictions of the study (including willingness to use the assigned study products per instructions, availability on scheduled visit dates and likeliness of completing the clinical study) based upon research site personnel's assessment
- Negative pregnancy urine tests (females of child bearing 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 gradable teeth including 4 molars with scorable both facial and lingual surfaces.Teeth that are grossly carious, extensively restored, orthodontically banded, abutments, exhibiting severe generalized cervical and/or enamel abrasion, teeth with veneers, or third molars will not be included in the tooth count
- Diabetes Type 1 or Type 2-self reported
- An HB A1C level less than (\<) 7.0 percent (%) for Type 1 Diabetes and an HB A1C level of \<8.0% for Type 2 Diabetes
- A mean gingival index greater than or equal to (\>=) 1.85 per the Modified Gingival Index at Baseline
- A mean plaque index \>= 1.95 per the 6 site Turesky modification of the Quigley-Hein Plaque Index at Baseline
Exclusion
- Dental prophylaxis within four weeks prior to baseline visit
- More than 3 sites having pocket depths of 5 millimeter (mm) or any sites that are greater than 5 mm in depth
- History of medical conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures
- A recent history of hypoglycemia requiring medical intervention within the past 30 days
- Use of antibiotics, anti-inflammatory or anticoagulant therapy, phenytoin sodium or diphenylhydantoin, calcium channel blockers, cyclosporin A, immunostimulants/ immunomodulators 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
Key Trial Info
Start Date :
December 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 6 2020
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT04449952
Start Date
December 2 2019
End Date
March 6 2020
Last Update
August 7 2023
Active Locations (1)
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1
Salus Research, Inc.
Fort Wayne, Indiana, United States, 46825