NCT01156376

Brief Summary

This study is 25 days long. People participating in this study will be asked to brush their teeth two times a day. People will be assigned to a mouthwash and will rinse four times a day at the site for five days. A dentist or dental hygienist will look at the mouth, teeth, tongue and gums to make sure the mouthwash does not irritate the mouth. After Day 5 of the study, people will continue to brush two times a day and will return on Day 24 to have their mouth looked at again. People without irritation in their mouth will rinse 4 times a day at the clinical site. People will return to the clinical site the next day and have a final oral exam in which the dentist or dental hygienist will look at the mouth for irritation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2010

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 2, 2010

Completed
5 years until next milestone

Results Posted

Study results publicly available

June 15, 2015

Completed
Last Updated

August 24, 2015

Status Verified

August 1, 2015

Enrollment Period

1 month

First QC Date

June 30, 2010

Results QC Date

May 28, 2015

Last Update Submit

August 5, 2015

Conditions

Oral Manifestations

Outcome Measures

Primary Outcomes (72)

  • Percentage of Participants With an Abnormal Condition by Anatomical Site at Screening

    Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.

    Screening

  • Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 1 - Baseline/Pretreatment

    Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.

    Day 1 - Baseline/Pretreatment

  • Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 1 - Post-treatment

    Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.

    Day 1 - Post-treatment

  • Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 3

    Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.

    Day 3

  • Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 5

    Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.

    Day 5

  • Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 24 - Pretreatment

    Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.

    Day 24 - Pretreatment

  • Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 24 - Post-treatment

    Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.

    Day 24 - Post-treatment

  • Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 25

    Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.

    Day 25

  • Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Screening

    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Screening

  • Percentage of Subjects in Irritation Score Category for Labial Mucosa at Screening

    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Screening

  • Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Screening

    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Screening

  • Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Screening

    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Screening

  • Percentage of Subjects in Irritation Score Category for Gingiva at Screening

    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Screening

  • Percentage of Subjects in Irritation Score Category for Tongue at Screening

    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Screening

  • Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Screening

    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Screening

  • Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Screening

    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Screening

  • Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 1 - Baseline/Pretreatment

    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Day 1 - Baseline/Pretreatment

  • Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 1 - Baseline/Pretreatment

    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Day 1 - Baseline/Pretreatment

  • Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 1 - Baseline/Pretreatment

    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Day 1 - Baseline/Pretreatment

  • Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 1 - Baseline/Pretreatment

    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Day 1 - Baseline/Pretreatment

  • Percentage of Subjects in Irritation Score Category for Gingiva at Day 1 - Baseline/Pretreatment

    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Day 1 - Baseline/Pretreatment

  • Percentage of Subjects in Irritation Score Category for Tongue at Day 1 - Baseline/Pretreatment

    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Day 1 - Baseline/Pretreatment

  • Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 1 - Baseline/Pretreatment

    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Day 1 - Baseline/Pretreatment

  • Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 1 - Baseline/Pretreatment

    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Day 1 - Baseline/Pretreatment

  • Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 1 - Post-treatment

    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Day 1 - Post-treatment

  • Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 1 - Post-treatment

    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Day 1 - Post-treatment

  • Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 1 - Post-treatment

    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Day 1 - Post-treatment

  • Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 1 - Post-treatment

    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Day 1 - Post-treatment

  • Percentage of Subjects in Irritation Score Category for Gingiva at Day 1 - Post-treatment

    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Day 1 - Post-treatment

  • Percentage of Subjects in Irritation Score Category for Tongue at Day 1 - Post-treatment

    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Day 1 - Post-treatment

  • Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 1 - Post-treatment

    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Day 1 - Post-treatment

  • Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 1 - Post-treatment

    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Day 1 - Post-treatment

  • Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 3

    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Day 3

  • Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 3

    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Day 3

  • Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 3

    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Day 3

  • Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 3

    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Day 3

  • Percentage of Subjects in Irritation Score Category for Gingiva at Day 3

    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Day 3

  • Percentage of Subjects in Irritation Score Category for Tongue at Day 3

    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Day 3

  • Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 3

    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Day 3

  • Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 3

    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Day 3

  • Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 5

    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Day 5

  • Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 5

    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Day 5

  • Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 5

    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Day 5

  • Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 5

    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Day 5

  • Percentage of Subjects in Irritation Score Category for Gingiva at Day 5

    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Day 5

  • Percentage of Subjects in Irritation Score Category for Tongue at Day 5

    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Day 5

  • Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 5

    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Day 5

  • Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 5

    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Day 5

  • Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 24 - Pretreatment

    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Day 24 - Pretreatment

  • Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 24 - Pretreatment

    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Day 24 - Pretreatment

  • Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 24 - Pretreatment

    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Day 24 - Pretreatment

  • Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 24 - Pretreatment

    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Day 24 - Pretreatment

  • Percentage of Subjects in Irritation Score Category for Gingiva at Day 24 - Pretreatment

    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Day 24 - Pretreatment

  • Percentage of Subjects in Irritation Score Category for Tongue at Day 24 - Pretreatment

    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Day 24 - Pretreatment

  • Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 24 - Pretreatment

    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Day 24 - Pretreatment

  • Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 24 - Pretreatment

    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Day 24 - Pretreatment

  • Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 24 - Post-treatment

    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Day 24 - Post-treatment

  • Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 24 - Post-treatment

    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Day 24 - Post-treatment

  • Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 24 - Post-treatment

    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Day 24 - Post-treatment

  • Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 24 - Post-treatment

    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Day 24 - Post-treatment

  • Percentage of Subjects in Irritation Score Category for Gingiva at Day 24 - Post-treatment

    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Day 24 - Post-treatment

  • Percentage of Subjects in Irritation Score Category for Tongue at Day 24 - Post-treatment

    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Day 24 - Post-treatment

  • Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 24 - Post-treatment

    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Day 24 - Post-treatment

  • Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 24 - Post-treatment

    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Day 24 - Post-treatment

  • Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 25

    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Day 25

  • Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 25

    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Day 25

  • Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 25

    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Day 25

  • Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 25

    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Day 25

  • Percentage of Subjects in Irritation Score Category for Gingiva at Day 25

    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Day 25

  • Percentage of Subjects in Irritation Score Category for Tongue at Day 25

    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Day 25

  • Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 25

    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Day 25

  • Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 25

    The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

    Day 25

Study Arms (3)

PO-019

EXPERIMENTAL

Formula 12027-019 Mouthwash

Device: Potassium Oxalate without Fluoride

PO-020

EXPERIMENTAL

Formula 12027-020 Mouthwash

Device: Potassium Oxalate with Fluoride

PO-116-A

ACTIVE COMPARATOR

Cool Mint Listerine

Device: Active Comparator PO-116-A

Interventions

Potassium Oxalate without FluorideDEVICE

1.40% Potassium Oxalate Sensitive Mouthwash without fluoride - Rinse with 10ml for 60 seconds, four times daily successively at 1 hour intervals for five days

Also known as: Formula 12027-019
PO-019
Potassium Oxalate with FluorideDEVICE

1.40% Potassium Oxalate Sensitive Mouthwash with fluoride - Rinse with 20ml for 60 seconds, four times daily successively at 1 hour intervals for five days

Also known as: Formula 12027-020
PO-020
Active Comparator PO-116-ADEVICE

Rinse with comparator mouthwash 20ml for 30 seconds, four times daily successively at 1 hour intervals for five days

Also known as: Cool Mint Listerine
PO-116-A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females at least 18 years of age in good general and oral health without any known allergy to commercial dental products or cosmetics.
  • Evidence of a personally signed and dated informed consent document indicating the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial.
  • Willingness to use the assigned products according to instructions, availability for appointments, and likelihood of completing the clinical trial.
  • Willingness to refrain from using any breath freshener products (e.g., oral care strips, candy-type mints, sprays, chewing gums, throat lozenges, cough drops or mouthwashes), whitening products and smokeless tobacco products within one week prior to and for the duration of the study, in order to reduce alternate sources of potential irritation and sensitization.
  • A minimum of 20 natural teeth.
  • Absence of abnormal or severe fissured tongue, geographic tongue, or any obvious tongue abnormalities that may interfere with the assessment of oral irritation.
  • Adequate oral hygiene (i.e., brush teeth daily \& exhibit no signs of oral neglect).
  • Absence of neglected dental health (i.e., gross calculus deposits or rampant caries based on visual examination), significant oral soft tissue pathology, systematically-related gingival enlargement or tissue damage due to ill-fitting appliances or restoration.
  • Absence of orthodontic bands, appliances, bridges, extensive large restorations or removable orthodontic appliances.

You may not qualify if:

  • Volunteers who report history or presence of kidney disorders or kidney stones, Crohn's Disease or other malabsorption syndromes.
  • History of significant adverse effects following use of oral hygiene products such as toothpastes and mouthwashes.
  • Physical limitations or restrictions that might preclude use of normal oral hygiene procedures (i.e., toothbrushing, mouthrinsing, etc.).
  • History or current evidence of significant oral soft tissue pathology, excluding gingivitis, based on the dentist's visual examination and at the discretion of the investigator.
  • Those requiring antibiotic premedication prior to dental treatment.
  • Participation in a dental clinical trial involving oral care products within the past 30 days.
  • Visual evidence of Moderate/Advanced Periodontitis (ADA Type III, IV).
  • Women who are pregnant, nursing or plan to become pregnant during the course of the study.
  • Volunteers requiring treatment with Indinavir or loop diuretics (i.e., Furosemide).
  • Other severe, acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or may interfere with the interpretation of trial result and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial
  • Any clinical history which in the opinion of the investigator could compromise the safety of the subject or the clinical parameters being assessed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Park Research Center (UPRC)

Fort Wayne, Indiana, 46825, United States

Location

MeSH Terms

Conditions

Oral Manifestations

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Michael Lynch, DMD, PhD/Study Director
Organization
Johnson & Johnson Consumer and Personal Products Worldwide
mlynch23@its.jnj.com
908-433-6423 USA EST

Study Officials

  • Michael Lynch, DMD, PhD

    Johnson & Johnson Consumer and Personal Products Worldwide

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2010

First Posted

July 2, 2010

Study Start

June 1, 2010

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

August 24, 2015

Results First Posted

June 15, 2015

Record last verified: 2015-08

Locations

US(1)