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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-02

Study Completion Date

2020-03-06

Brief Summary

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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.

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Detailed Description

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Conditions

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Gingivits in Diabetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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AFEO-Containing Mouth Rinse

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.

Group Type EXPERIMENTAL

Colgate Cavity Protection Toothpaste

Intervention Type OTHER

Participants used Colgate cavity protection toothpaste for brushing teeth twice daily.

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

Intervention Type OTHER

Participants use 20 mL of AFEO mouth rinse lead formula for 30 sec after brushing.

Concept Curve Winter Series Toothbrush

Intervention Type DEVICE

Participants will brush teeth at least one minute with provided bristled toothbrush.

Listerine Cool Mint Floss

Intervention Type DEVICE

Participants will use marketed fluoride-containing dentifrice, floss.

Listerine Cool Mint Mouth Rinse (Marketed product)

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.

Group Type EXPERIMENTAL

Listerine Cool Mint

Intervention Type OTHER

Participants use 20 mL of Listerine cool mint mouth rinse for 30 sec after brushing

Colgate Cavity Protection Toothpaste

Intervention Type OTHER

Participants used Colgate cavity protection toothpaste for brushing teeth twice daily.

Concept Curve Winter Series Toothbrush

Intervention Type DEVICE

Participants will brush teeth at least one minute with provided bristled toothbrush.

Listerine Cool Mint Floss

Intervention Type DEVICE

Participants will use marketed fluoride-containing dentifrice, floss.

5 Percent (%) Hydroalcohol Mouth Rinse

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.

Group Type EXPERIMENTAL

5% Hydroalcohol Mouth Rinse

Intervention Type OTHER

Participants use 20 mL of 5% Hydroalcohol mouth rinse for 30 sec after brushing.

Colgate Cavity Protection Toothpaste

Intervention Type OTHER

Participants used Colgate cavity protection toothpaste for brushing teeth twice daily.

Concept Curve Winter Series Toothbrush

Intervention Type DEVICE

Participants will brush teeth at least one minute with provided bristled toothbrush.

Listerine Cool Mint Floss

Intervention Type DEVICE

Participants will use marketed fluoride-containing dentifrice, floss.

Interventions

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Listerine Cool Mint

Participants use 20 mL of Listerine cool mint mouth rinse for 30 sec after brushing

Intervention Type OTHER

5% Hydroalcohol Mouth Rinse

Participants use 20 mL of 5% Hydroalcohol mouth rinse for 30 sec after brushing.

Intervention Type OTHER

Colgate Cavity Protection Toothpaste

Participants used Colgate cavity protection toothpaste for brushing teeth twice daily.

Intervention Type 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.

Intervention Type OTHER

Concept Curve Winter Series Toothbrush

Participants will brush teeth at least one minute with provided bristled toothbrush.

Intervention Type DEVICE

Listerine Cool Mint Floss

Participants will use marketed fluoride-containing dentifrice, floss.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No