A Study to Determine the Effects of Adding an Experimental Device With Mouthrinse to Oral Care Regimen

Completed · Not applicable

Conditions studied: Gingivitis

In brief

The study will determine the effects of adding mechanical plaque control to a person's oral care regimen. Participants who qualify to participate in the study will will have an equal chance of being assigned to one of three groups. They will be asked to follow their assigned oral care regimen, fill out subject diaries as instructed, and return to the clinic two weeks and four weeks afterward to have their mouths examined.

Key facts

Study ID

NCT01419626

Run by

Johnson & Johnson Consumer and Personal Products Worldwide

People needed

140

Starts

2011-07-31

Expected to finish

2011-08-31

Last updated by the study team

2019-12-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Able to comprehend and follow the requirements of the study (including availability on scheduled visit dates) based upon research site personnel's assessment.
• Able to provide written informed consent; volunteers must read, sign, and receive a copy of the signed Informed Consent Form after the nature of the study has been fully explained.
• Males and females 18 years of age or older, in good general and oral health, except gingivitis.
• A minimum of 20 natural teeth with scorable facial and lingual surfaces. Teeth that are grossly carious, extensively restored, orthodontically banded, abutments, exhibiting severe generalized cervical and/or enamel abrasion, or third molars will not be included in the tooth count.
• A gingival index ≥ 1.75 according to the Modified Gingival Index.
• A plaque index ≥ 1.95 according to the Turesky modification of the Quigley-Hein Plaque Index scored on six surfaces per tooth.
• Gingival Bleeding Index ≥ 0.1.
• Absence of significant oral soft tissue pathology, excluding plaque-induced gingivitis, based on a visual examination and at the discretion of the Investigator.
• Absence of moderate/advanced periodontitis based on a clinical examination (ADA Type III, IV).
• Absence of fixed or removable orthodontic appliance or removable partial dentures.
• Are willing and able to fully understand and comply with the written and verbal study instructions provided in English
• Agree to return all study materials at the final visit (week 4).

You may not qualify if…

• History of significant adverse effects, including sensitivities or suspected allergies, following use of oral hygiene products such as toothpastes and mouthrinses and red food dye.
• History of serious medical conditions that, at the discretion of the Investigator, will disqualify the subject, such as having have a cardiac pacemaker or AICD.
• History of rheumatic fever, heart murmur, mitral valve prolapse or other conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures.
• Antibiotic, anti-inflammatory or anticoagulant therapy during the study or within the 2 weeks prior to the baseline exam.
• Regular use of chemotherapeutic antiplaque/antigingivitis products such as triclosan, essential oil, cetylpyridinium chloride, or chlorhexidine containing mouthrinses within the 2 weeks prior to baseline.
• Current or history of alcohol or drug abuse, and those who smoke more than one pack of cigarettes per day
• Females who are pregnant or breastfeeding.
• Known sensitivity to the investigational product.
• Significant unstable or uncontrolled medical condition which may interfere with a subject's participation in the study.
• Participation in any clinical study within 30 days of Visit 1.
• Relative, partner or staff of any clinical research site personnel.
• A member of the same household (i.e. residing in the same house) is a participant in this study.
• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
• Are employed by an oral healthcare products company or dental research institution (i.e., dental school: administrative staff, assistants, hygienists, and research students).

Where it is running

• BioSci Research America, Inc — Las Vegas, Nevada, United States

Full record on ClinicalTrials.gov

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