Clinical trial NCT04449952: A Study of Mouth Rinses in Type 1 and Type 2 Diabetic Participants
Official title: Safety and Clinical Efficacy of Mouth Rinses in Type 1 and Type 2 Diabetics: Effect on Oral Soft Tissue, Plaque and Gingivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gingivits in Diabetics
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2020-06-29
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 daily as an adjunct to tooth brushing during a twelve-week treatment period.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Whole-Mouth Mean Modified Gingival Index (MGI) Score After 12 Weeks of Product use
timeFrame: 12 Weeks
measure: Whole Mouth Mean Turesky Plaque Index (TPI) Score After 12 Weeks of Product use
timeFrame: 12 Weeks
Secondary outcomes:
measure: Whole Mouth Mean Turesky Plaque Index (TPI) Score After 1 and 6 Weeks of Product use
timeFrame: 1 Week and 6 Weeks
measure: Whole-Mouth Mean Modified Gingival Index (MGI) Score After 6 Weeks of Product use
timeFrame: 6 Weeks
measure: Whole-Mouth Mean Expanded Bleeding Index (EBI) Score After 6 and 12 Weeks of Product use
timeFrame: 6 Weeks and 12 Weeks
measure: Percentage of Bleeding Sites, Based on the Expanded Gingival Bleeding Index Score After 6 and 12 Weeks of Product use
timeFrame: 6 Weeks and 12 Weeks
Other outcomes:
Locations:
city: Fort Wayne
country: United States
facility: Salus Research, Inc.
state: Indiana
Study officials:
affiliation: Salus Research, Inc.
name: Jeffery Milleman
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leite RS, Marlow NM, Fernandes JK, Hermayer K. Oral health and type 2 diabetes. Am J Med Sci. 2013 Apr;345(4):271-273. doi: 10.1097/MAJ.0b013e31828bdedf.
citation: Qaseem A, Wilt TJ, Kansagara D, Horwitch C, Barry MJ, Forciea MA; Clinical Guidelines Committee of the American College of Physicians; Fitterman N, Balzer K, Boyd C, Humphrey LL, Iorio A, Lin J, Maroto M, McLean R, Mustafa R, Tufte J. Hemoglobin A1c Targets for Glycemic Control With Pharmacologic Therapy for Nonpregnant Adults With Type 2 Diabetes Mellitus: A Guidance Statement Update From the American College of Physicians. Ann Intern Med. 2018 Apr 17;168(8):569-576. doi: 10.7326/M17-0939. Epub 2018 Mar 6.