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NOT YET RECRUITING
NCT05031260
NA

COMORAL® the Oral Irrigation Unit Clinical Trial

Sponsor: University of California, Los Angeles

View on ClinicalTrials.gov

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

Interventions

DEVICE

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.