Oral Irritation Study of Two Experimental Mouthrinses

Completed · Not applicable

Conditions studied: Oral Manifestations

In brief

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.

Key facts

Study ID

NCT01156376

Run by

Johnson & Johnson Consumer and Personal Products Worldwide

People needed

80

Starts

2010-06-01

Expected to finish

2010-07-01

Last updated by the study team

2015-08-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• University Park Research Center (UPRC) — Fort Wayne, Indiana, United States

Full record on ClinicalTrials.gov

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