Clinical trial NCT01156376: Oral Irritation Study of Two Experimental Mouthrinses
Official title: Determination of the Oral Irritation and Sensitization Potential of Two Experimental Potassium Oxalate Containing Mouthrinses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Manifestations
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2010-07-02
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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 description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percentage of Participants With an Abnormal Condition by Anatomical Site at Screening
timeFrame: Screening
measure: Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 1 - Baseline/Pretreatment
timeFrame: Day 1 - Baseline/Pretreatment
measure: Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 1 - Post-treatment
timeFrame: Day 1 - Post-treatment
measure: Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 3
timeFrame: Day 3
measure: Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 5
timeFrame: Day 5
measure: Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 24 - Pretreatment
timeFrame: Day 24 - Pretreatment
measure: Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 24 - Post-treatment
timeFrame: Day 24 - Post-treatment
measure: Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 25
timeFrame: Day 25
measure: Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Screening
timeFrame: Screening
measure: Percentage of Subjects in Irritation Score Category for Labial Mucosa at Screening
timeFrame: Screening
measure: Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Screening
timeFrame: Screening
measure: Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Screening
timeFrame: Screening
measure: Percentage of Subjects in Irritation Score Category for Gingiva at Screening
timeFrame: Screening
measure: Percentage of Subjects in Irritation Score Category for Tongue at Screening
timeFrame: Screening
measure: Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Screening
timeFrame: Screening
measure: Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Screening
timeFrame: Screening
measure: Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 1 - Baseline/Pretreatment
timeFrame: Day 1 - Baseline/Pretreatment
measure: Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 1 - Baseline/Pretreatment
timeFrame: Day 1 - Baseline/Pretreatment
measure: Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 1 - Baseline/Pretreatment
timeFrame: Day 1 - Baseline/Pretreatment
measure: Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 1 - Baseline/Pretreatment
timeFrame: Day 1 - Baseline/Pretreatment
measure: Percentage of Subjects in Irritation Score Category for Gingiva at Day 1 - Baseline/Pretreatment
timeFrame: Day 1 - Baseline/Pretreatment
measure: Percentage of Subjects in Irritation Score Category for Tongue at Day 1 - Baseline/Pretreatment
timeFrame: Day 1 - Baseline/Pretreatment
measure: Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 1 - Baseline/Pretreatment
timeFrame: Day 1 - Baseline/Pretreatment
measure: Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 1 - Baseline/Pretreatment
timeFrame: Day 1 - Baseline/Pretreatment
measure: Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 1 - Post-treatment
timeFrame: Day 1 - Post-treatment
measure: Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 1 - Post-treatment
timeFrame: Day 1 - Post-treatment
measure: Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 1 - Post-treatment
timeFrame: Day 1 - Post-treatment
measure: Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 1 - Post-treatment
timeFrame: Day 1 - Post-treatment
measure: Percentage of Subjects in Irritation Score Category for Gingiva at Day 1 - Post-treatment
timeFrame: Day 1 - Post-treatment
measure: Percentage of Subjects in Irritation Score Category for Tongue at Day 1 - Post-treatment
timeFrame: Day 1 - Post-treatment
measure: Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 1 - Post-treatment
timeFrame: Day 1 - Post-treatment
measure: Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 1 - Post-treatment
timeFrame: Day 1 - Post-treatment
measure: Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 3
timeFrame: Day 3
measure: Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 3
timeFrame: Day 3
measure: Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 3
timeFrame: Day 3
measure: Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 3
timeFrame: Day 3
measure: Percentage of Subjects in Irritation Score Category for Gingiva at Day 3
timeFrame: Day 3
measure: Percentage of Subjects in Irritation Score Category for Tongue at Day 3
timeFrame: Day 3
measure: Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 3
timeFrame: Day 3
measure: Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 3
timeFrame: Day 3
measure: Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 5
timeFrame: Day 5
measure: Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 5
timeFrame: Day 5
measure: Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 5
timeFrame: Day 5
measure: Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 5
timeFrame: Day 5
measure: Percentage of Subjects in Irritation Score Category for Gingiva at Day 5
timeFrame: Day 5
measure: Percentage of Subjects in Irritation Score Category for Tongue at Day 5
timeFrame: Day 5
measure: Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 5
timeFrame: Day 5
measure: Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 5
timeFrame: Day 5
measure: Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 24 - Pretreatment
timeFrame: Day 24 - Pretreatment
measure: Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 24 - Pretreatment
timeFrame: Day 24 - Pretreatment
measure: Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 24 - Pretreatment
timeFrame: Day 24 - Pretreatment
measure: Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 24 - Pretreatment
timeFrame: Day 24 - Pretreatment
measure: Percentage of Subjects in Irritation Score Category for Gingiva at Day 24 - Pretreatment
timeFrame: Day 24 - Pretreatment
measure: Percentage of Subjects in Irritation Score Category for Tongue at Day 24 - Pretreatment
timeFrame: Day 24 - Pretreatment
measure: Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 24 - Pretreatment
timeFrame: Day 24 - Pretreatment
measure: Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 24 - Pretreatment
timeFrame: Day 24 - Pretreatment
measure: Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 24 - Post-treatment
timeFrame: Day 24 - Post-treatment
measure: Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 24 - Post-treatment
timeFrame: Day 24 - Post-treatment
measure: Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 24 - Post-treatment
timeFrame: Day 24 - Post-treatment
measure: Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 24 - Post-treatment
timeFrame: Day 24 - Post-treatment
measure: Percentage of Subjects in Irritation Score Category for Gingiva at Day 24 - Post-treatment
timeFrame: Day 24 - Post-treatment
measure: Percentage of Subjects in Irritation Score Category for Tongue at Day 24 - Post-treatment
timeFrame: Day 24 - Post-treatment
measure: Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 24 - Post-treatment
timeFrame: Day 24 - Post-treatment
measure: Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 24 - Post-treatment
timeFrame: Day 24 - Post-treatment
measure: Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 25
timeFrame: Day 25
measure: Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 25
timeFrame: Day 25
measure: Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 25
timeFrame: Day 25
measure: Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 25
timeFrame: Day 25
measure: Percentage of Subjects in Irritation Score Category for Gingiva at Day 25
timeFrame: Day 25
measure: Percentage of Subjects in Irritation Score Category for Tongue at Day 25
timeFrame: Day 25
measure: Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 25
timeFrame: Day 25
measure: Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 25
timeFrame: Day 25
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Wayne
country: United States
facility: University Park Research Center (UPRC)
state: Indiana
Study officials:
affiliation: Johnson & Johnson Consumer and Personal Products Worldwide
name: Michael Lynch, DMD, PhD
role: STUDY_DIRECTOR
References: