NCT04449952

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

Safety and Clinical Efficacy of Mouth Rinses in Type 1 and Type 2 Diabetics: Effect on Oral Soft Tissue, Plaque and Gingivitis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 154 (actual)
• Sponsor: Johnson & Johnson Consumer Inc. (J&JCI) · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gingivits in Diabetics

Interventions

Type	Name	Description
OTHER	Listerine Cool Mint	Participants use 20 mL of Listerine cool mint mouth rinse for 30 sec after brushing
OTHER	5% Hydroalcohol Mouth Rinse	Participants use 20 mL of 5% Hydroalcohol mouth rinse for 30 sec after brushing.
OTHER	Colgate Cavity Protection Toothpaste	Participants used Colgate cavity protection toothpaste for brushing teeth twice daily.
OTHER	Alcohol-Free Essential Oil Containing (AFEO) Mouth Rinse Lead Formula	Participants use 20 mL of AFEO mouth rinse lead formula for 30 sec after brushing.
DEVICE	Concept Curve Winter Series Toothbrush	Participants will brush teeth at least one minute with provided bristled toothbrush.
DEVICE	Listerine Cool Mint Floss	Participants will use marketed fluoride-containing dentifrice, floss.

Timeline

• Start date: 2019-12-02
• Primary completion: 2020-03-06
• Completion: 2020-03-06
• First posted: 2020-06-29
• Last updated: 2023-08-07

Locations

1 site across 1 country: United States