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

August 4, 2023 updated by: Johnson & Johnson Consumer Inc. (J&JCI)

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
154

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Fort Wayne, Indiana, United States, 46825
        • Salus Research, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
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.
Experimental: 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.
Other: Colgate Cavity Protection Toothpaste
Participants used Colgate cavity protection toothpaste for brushing teeth twice daily.
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.
Other: Listerine Cool Mint
Participants use 20 mL of Listerine cool mint mouth rinse for 30 sec after brushing
Experimental: 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.
Other: Colgate Cavity Protection Toothpaste
Participants used Colgate cavity protection toothpaste for brushing teeth twice daily.
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.
Other: 5% Hydroalcohol Mouth Rinse
Participants use 20 mL of 5% Hydroalcohol mouth rinse for 30 sec after brushing.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Whole-Mouth Mean Modified Gingival Index (MGI) Score After 12 Weeks of Product use
Time Frame: 12 Weeks
Gingivitis will be assessed by the Modified Gingival Index on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth: 0 (Normal [absence of inflammation]), 1 (Mild inflammation [slight change in color, little change in texture] of any portion of the entire gingival unit); 2 (Mild inflammation of the entire gingival unit); 3 (Moderate inflammation [moderate glazing, redness, edema, and/or hypertrophy] of the gingival unit); 4 (Severe inflammation [marked redness and edema/hypertrophy, spontaneous bleeding, or ulceration] of the gingival unit).
12 Weeks
Whole Mouth Mean Turesky Plaque Index (TPI) Score After 12 Weeks of Product use
Time Frame: 12 Weeks
Plaque area will be scored by the Turesky modification of the Quigley-Hein Plaque Index, on 6 surfaces (distobuccal, midbuccal and mesiobuccal, distolingual, midlingual and mesiolingual) of all scorable teeth, following disclosing: 0 (No Plaque); 1 (Separate flecks or discontinuous band of plaque around the gingival (cervical) margin); 2 (Thin (up to 1 millimeter [mm]), continuous band of plaque at the gingival margin); 3 (Band of plaque wider than 1mm but less than1/3 of the surface); 4 (Plaque covering 1/3 or more, but less than 2/3 of the surface); 5 (Plaque covering 2/3 or more of the surface).
12 Weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Whole Mouth Mean Turesky Plaque Index (TPI) Score After 1 and 6 Weeks of Product use
Time Frame: 1 Week and 6 Weeks
Plaque area will be scored by the Turesky modification of the Quigley-Hein Plaque Index, on 6 surfaces (distobuccal, midbuccal and mesiobuccal, distolingual, midlingual and mesiolingual) of all scorable teeth, following disclosing: 0 (No Plaque); 1 (Separate flecks or discontinuous band of plaque around the gingival (cervical) margin); 2 (Thin (up to 1 millimeter [mm]), continuous band of plaque at the gingival margin); 3 (Band of plaque wider than 1mm but less than1/3 of the surface); 4 (Plaque covering 1/3 or more, but less than 2/3 of the surface); 5 (Plaque covering 2/3 or more of the surface).
1 Week and 6 Weeks
Whole-Mouth Mean Modified Gingival Index (MGI) Score After 6 Weeks of Product use
Time Frame: 6 Weeks
Gingivitis will be assessed by the Modified Gingival Index on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth: 0 (Normal [absence of inflammation]), 1 (Mild inflammation [slight change in color, little change in texture] of any portion of the entire gingival unit); 2 (Mild inflammation of the entire gingival unit); 3 (Moderate inflammation [moderate glazing, redness, edema, and/or hypertrophy] of the gingival unit); 4 (Severe inflammation [marked redness and edema/hypertrophy, spontaneous bleeding, or ulceration] of the gingival unit).
6 Weeks
Whole-Mouth Mean Expanded Bleeding Index (EBI) Score After 6 and 12 Weeks of Product use
Time Frame: 6 Weeks and 12 Weeks
Bleeding will be assessed according to the Expanded Gingival Bleeding Index, 168 Sites. A periodontal probe with a 0.5 millimeter (mm) diameter tip will be inserted into the gingival crevice and swept from distal to mesial around the tooth at an angle of approximately 60 degree, while in contact with the sulcular epithelium. Each of 6 gingival areas (distobuccal, mid-buccal, mesiobuccal, distolingual, mid-lingual, and mesiolingual) around each tooth will be assessed. After approximately 30 seconds, bleeding at each gingival unit will be recorded according to the following scale: 0 (Absence of bleeding after 30 seconds); 1 (Bleeding after 30 seconds); 2 (Immediate bleeding).
6 Weeks and 12 Weeks
Percentage of Bleeding Sites, Based on the Expanded Gingival Bleeding Index Score After 6 and 12 Weeks of Product use
Time Frame: 6 Weeks and 12 Weeks
Percent bleeding sites will be calculated by taking the total number of sites with bleeding score greater than 0 divided by the total number of sites assessed for each participant. Bleeding will be assessed according to the Expanded Gingival Bleeding Index, 168 Sites. A periodontal probe with a 0.5 millimeter (mm) diameter tip will be inserted into the gingival crevice and swept from distal to mesial around the tooth at an angle of approximately 60 degree, while in contact with the sulcular epithelium. Each of 6 gingival areas (distobuccal, mid-buccal, mesiobuccal, distolingual, mid-lingual, and mesiolingual) around each tooth will be assessed. After approximately 30 seconds, bleeding at each gingival unit will be recorded according to the following scale: 0 (Absence of bleeding after 30 seconds); 1 (Bleeding after 30 seconds); 2 (Immediate bleeding).
6 Weeks and 12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johnson & Johnson Consumer Inc. (J&JCI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jeffery Milleman, Salus Research, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 2, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 6, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 6, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 24, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 29, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 7, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CCSORC002281 (Other Identifier: Johnson & Johnson Consumer Inc. (J&JCI))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Johnson & Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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