Oral Irritation Study of Two Experimental Mouthrinses

This is an interventional basic science trial for Oral Manifestations Read More

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