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COMORAL® the Oral Irrigation Unit Clinical Trial
Sponsor: University of California, Los Angeles
Summary
This is a clinical study to evaluate the safety and effectiveness of COMORAL®, the intraoral water-spraying cleaning device that is developed to remove plaque around teeth in the oral cavity. To do so, 42 healthy subjects, 21 control and 21 experimental, will be recruited. To establish the baseline, all subjects will receive dental hygiene service. After 2 weeks, patients will be randomly assigned to either control or intervention group (21 individuals each). Both groups will be asked to brush their teeth once a day but without dental floss, mouth rinse, and gum chewing, throughout the 4 weeks of study period. During the study period, the experimental group will receive COMORAL® treatment three times a day every day for 4 weeks except Saturday and Sunday. Subjects will get evaluated for the oral status(PI, BOP, GI, PD, GR, CAL) and the status of periopathogens on visit 1, visit 2 and visit 3.
Official title: Effect of COMORAL® the Oral Irrigation Unit in Preventing Gingivitis and Plaque Formation
Key Details
Gender
All
Age Range
18 Years - 25 Years
Study Type
INTERVENTIONAL
Enrollment
42
Start Date
2021-10-01
Completion Date
2022-06-30
Last Updated
2021-09-01
Healthy Volunteers
Yes
Conditions
Interventions
applying COMORAL®
The individuals in the experimental group will be asked to come to the clinic to use COMORAL® three times a day, every day except Saturday and Sunday.