NCT01419626

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

Antiplaque and Antigingivitis Efficacy of Interdental Cleaning Using an Experimental Device in Combination With an Essential-oil Containing Mouthrinse

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

At baseline, the prescreened subjects will present to the clinical site for baseline examinations (oral exam, plaque, gingivitis and gingival bleeding assessments) having refrained from oral hygiene for at least 12 hours, but no more than 18 hours and from eating for at least 2 hours prior to that examination. After the baseline oral examinations, and assessment of other inclusion/exclusion criteria, qualifying subjects will be randomly assigned to one of the three treatment groups. Immediately following this randomization, all subjects will begin their regimen of brushing with a manual toothbrush while two of the groups will also receive an experimental interdental cleaning device to use either with water or with an assigned mouthrinse following the label instructions described on the experimental device label. Subjects who are assigned to the negative control group will use the manual toothbrush and provided toothpaste as their sole mean of oral hygiene. Subjects assigned to the Device-only control group will brush with a manual toothbrush and use the Experimental Interdental Cleaning Device with water. Finally, those subjects randomized to the test group will brush with a manual toothbrush and use the experimental interdental cleaning device in combination with a marketed antiseptic mouthrinse. Subjects will brush twice-a-day and if assigned, will use the experimental interdental cleaning device once-a-day for 4 weeks, post-brushing, according to instructions given by the study personnel. The first oral hygiene procedure will be conducted under supervision of study personnel at the research site. All other study material usage will be unsupervised and the subjects will be required to maintain a Diary Card to document daily oral hygiene routine. Compliance will be evaluated at each visit by reviewing the subject diaries and, when applicable, by weighing residual volumes of returned mouthrinse. Subjects will refrain from the use of any interdental cleaning device, unless assigned by the randomization schedule (i.e., not to use dental floss, toothpick, etc), unless it is used to remove impacted food between the teeth, during the course of the study. No other oral hygiene procedures will be permitted, including teeth cleaning or dental work except for an emergency. At the two and four-week visits, the Modified Gingival Index (MGI), the Bleeding Index (BI) and the Turesky modification of the Quigley-Hein Plaque Index (PI) will be scored and the oral tissue examinations performed. At the two and four-week visits, subjects will not have used their test materials for at least 12 hours, but no more than 18 hours.

Conditions

• Gingivitis

Interventions

Type	Name	Description
DEVICE	Interdental cleaning device with water	Subjects will be instructed to follow their usual oral hygiene habits with the provided toothbrush and toothpaste, and to use their assigned product once a day for a period of 4 weeks.
DEVICE	Interdental cleaning device with essential-oil mouthrinse	Subjects will be instructed to follow their usual oral hygiene habits with the provided toothbrush and toothpaste, and to use their assigned product once a day for a period of 4 weeks.

Timeline

• Start date: 2011-07-31
• Primary completion: 2011-08-31
• Completion: 2011-08-31
• First posted: 2011-08-18
• Last updated: 2019-12-17
• Results posted: 2019-12-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study