NCT01156376|CompletedResults
Oral Irritation Study of Two Experimental Mouthrinses
Determination of the Oral Irritation and Sensitization Potential of Two Experimental Potassium Oxalate Containing Mouthrinses
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Sponsor study identifier
interventional
80
1 country
1
Study Start
June 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2010
Actual (reported)Study Completion
July 2010
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2010
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2010
Date type not reportedThis date has not been verified as actual or estimated.
June 30, 2010
Actual (reported)July 2010
Actual (reported)July 2010
Actual (reported)July 2, 2010
Actual (reported)June 15, 2015
Actual (reported)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
Formula 12027-019 Mouthwash
Formula 12027-020 Mouthwash
Cool Mint Listerine
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
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
University Park Research Center (UPRC)
Fort Wayne, Indiana, 46825, United States
Michael Lynch, DMD, PhD
Johnson & Johnson Consumer and Personal Products Worldwide
80 participants (actual enrollment reported by the registry).
First Submitted
June 30, 2010
First Posted
July 2, 2010
Study Start
June 2010
Date type not reportedThis date has not been verified as actual or estimated.
The Effects of Using Augmented Reality (AR) System to Train Foreign Care Workers.
Rinse with comparator mouthwash 20ml for 30 seconds, four times daily successively at 1 hour intervals for five days
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
July 2010
Actual (reported)Study Completion
July 2010
Actual (reported)Last Updated
August 24, 2015
Results First Posted
June 15, 2015
Record last verified: 2015-08
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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