Clinical Trial: Oral Irritation Study of Two Experimental Mouthrinses

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Determination of the Oral Irritation and Sensitization Potential of Two Experimental Potassium Oxalate Containing Mouthrinses

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.

Detailed Summary:

This is a randomized, observer-blind, single-center, supervised, controlled, parallel-designed study. Approximately 90 generally healthy adults meeting the necessary inclusion/exclusion criteria will be enrolled so that 78 subjects (26 per treatment group) would reasonably be expected to complete the study. Subjects will have their oral soft/hard tissues assessed at Screening (visit 1), Baseline (visit 2), and Days 3, 5, 24, and 25 (visits 4,6-8). During the first week of the study, subjects will be instructed to brush their teeth for one minute in their usual manner, twice daily using the provided standard fluoride toothpaste. Subjects will return for the Baseline exam and, upon qualification with entry criteria, will be assigned to one of three treatment groups. Qualified subjects will be instructed to return to the site for five consecutive days. Subjects will have four supervised rinses with their assigned mouth rinse for either 30 or 60 seconds using 10 ml or 20 ml, at subsequent one-hour intervals. During the 5 consecutive days of exposure to the assigned mouthrinse, subjects will brush their teeth using the provided fluoride-free toothpaste and soft-bristled toothbrush.

Subjects will then have an 18-day rest period (off treatment). During this time, subjects will follow their usual oral hygiene and dietary habits, using the standard fluoride toothpaste and soft toothbrush provided, and must refrain from using any unassigned oral care products. On the 19th day after completion of Day 5 (Day 24), subjects will return for an oral examination. If no pathology is present, subjects will be given a challenge treatment (four supervised rinses) and the final oral examination will be performed on Day 25.

Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide

Current Primary Outcome:

• Percentage of Participants With an Abnormal Condition by Anatomical Site at Screening [ Time Frame: 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.
• Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 1 - Baseline/Pretreatment [ Time Frame: 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.
• Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 1 - Post-treatment [ Time Frame: 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.
• Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 3 [ Time Frame: 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.
• Percentage of Participants With an Abnormal Condition by Anatomical Site
  
  

  Original Primary Outcome:
  
  

  Current Secondary Outcome:
  
  

  Original Secondary Outcome:
  
  Information By: Johnson & Johnson Consumer and Personal Products Worldwide
  

  Dates:
  Date Received: June 30, 2010
  Date Started: June 2010
  Date Completion:
  Last Updated: August 5, 2015
  Last Verified: August 2015