About this trial
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.
Eligibility criteria
Qualifiers
Healthy adult patients (ASA 1-2) aged 18 to 25 with a probing depth of 3mm or less
Those with 3 or more natural teeth in each quartile
Those who can voluntarily sign the consent form
Disqualifiers
Existing dental caries
Existing periodontitis
Other oral diseases
Trial design
Treatments tested in this trial
- applying COMORAL®