Status:
COMPLETED
Oral Irritation Study of Two Experimental Mouthrinses
Lead Sponsor:
Johnson & Johnson Consumer and Personal Products Worldwide
Conditions:
Oral Manifestations
Eligibility:
All Genders
18+ years
Phase:
NA
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 fo...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01156376
Start Date
June 1 2010
End Date
July 1 2010
Last Update
August 24 2015
Active Locations (1)
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1
University Park Research Center (UPRC)
Fort Wayne, Indiana, United States, 46825