A Study of Mouth Rinses in Type 1 and Type 2 Diabetic Participants

Johnson & Johnson (J&J)

Status and phase: Completed; Phase 4

Conditions: Gingivits in Diabetics

Treatments: Other: Alcohol-Free Essential Oil Containing (AFEO) Mouth Rinse Lead Formula; Device: Concept Curve Winter Series Toothbrush; Other: Listerine Cool Mint; Other: Colgate Cavity Protection Toothpaste; Device: Listerine Cool Mint Floss; Other: 5% Hydroalcohol Mouth Rinse

Study type: Interventional

Funder types: Industry

Identifiers

NCT04449952

CCSORC002281 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 154 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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154 participants in 3 patient groups

AFEO-Containing Mouth Rinse

Experimental group

Description:

Participants with Diabetes (Type 1 and 2) will be randomized to receive AFEO-containing mouth rinse with a marketed fluoride-containing dentifrice, floss (if flossing is part of their normal oral care routine), a marketed soft bristled toothbrush and a timer (if needed). They will brush for at least one minute using full ribbon of a marketed toothpaste on the provided toothbrush. After brushing, rinse for 30 seconds with 20 milliliter (mL) of the assigned mouth rinse twice daily (morning and evening) for 12 consecutive Weeks.

Treatment:

Other: Alcohol-Free Essential Oil Containing (AFEO) Mouth Rinse Lead Formula

Device: Concept Curve Winter Series Toothbrush

Other: Colgate Cavity Protection Toothpaste

Device: Listerine Cool Mint Floss

Listerine Cool Mint Mouth Rinse (Marketed product)

Experimental group

Description:

Participants with Diabetes (Type 1 and 2) will be randomized to receive Listerine cool mint mouth rinse with a marketed fluoride-containing dentifrice, floss (if flossing is part of their normal oral care routine), a marketed soft bristled toothbrush and a timer (if needed). They will brush for at least one minute using full ribbon of a marketed toothpaste on the provided toothbrush. After brushing, rinse for 30 seconds with 20 mL of the assigned mouth rinse twice daily (morning and evening) for 12 consecutive Weeks.

Treatment:

Device: Concept Curve Winter Series Toothbrush

Other: Colgate Cavity Protection Toothpaste

Other: Listerine Cool Mint

Device: Listerine Cool Mint Floss

5 Percent (%) Hydroalcohol Mouth Rinse

Experimental group

Description:

Participants with Diabetes (Type 1 and 2) will be randomized to receive 5% Hydroalcohol mouth rinse with a marketed fluoride-containing dentifrice, floss (if flossing is part of their normal oral care routine), a marketed soft bristled toothbrush and a timer (if needed). They will brush for at least one minute using full ribbon of a marketed toothpaste on the provided toothbrush. After brushing, rinse for 30 seconds with 20 mL of the assigned mouth rinse twice daily (morning and evening) for 12 consecutive Weeks.

Treatment:

Device: Concept Curve Winter Series Toothbrush

Other: Colgate Cavity Protection Toothpaste

Device: Listerine Cool Mint Floss

Other: 5% Hydroalcohol Mouth Rinse