Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-29 @ 10:56 AM
Study NCT ID:
NCT05031260
Status:
NOT_YET_RECRUITING
Last Update Posted:
2021-09-01
First Post:
2021-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COMORAL® the Oral Irrigation Unit Clinical Trial
Sponsor:
University of California, Los Angeles
Organization:
Study Overview
Official Title:
Effect of COMORAL® the Oral Irrigation Unit in Preventing Gingivitis and Plaque Formation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COMORAL
Brief 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.
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.
Detailed Description:
This is a randomized, open-labeled, single-centered clinical study to evaluate COMORAL® the intraoral water-spraying cleaning device that is developed to remove plaque around teeth in the oral cavity. The purpose of this clinical study is to evaluate the safety and effectiveness of COMORAL® the oral irrigation unit in preventing gingivitis and plaque formation in adult patients.
42 patients between 18 to 25 years old who have a periodontal probing depth of 3 mm or less will be recruited. To establish the baseline, all the patients will receive dental hygiene service.
After 2 weeks (Visit 1), patients will be randomly assigned to either control or intervention group (21 individuals each). They will be asked to do the following instruction; Control group (21 total) - The individuals in the control group will be asked to brush their teeth once a day at home throughout the 4 weeks of study period. They will be asked not to use the supplementary oral hygiene products including mouth rinse, dental floss and chewing gum.
Experimental/Intervention group (21 total) - The individuals in this group will be asked to brush their teeth once a day at home throughout the 4 weeks of study period. They will be asked not to use the supplementary oral hygiene products including mouth rinse, dental floss and chewing gum. Instead, they will be asked to come to the clinic to use COMORAL® three times a day, every day except Saturday and Sunday.
Subjects in both groups will be evaluated for clinical indices (PI, BOP, GI, PD, GR, CAL) and the status of periopathogens on visit 1(baseline, visit 2(after 2 weeks), and visit 3(after 4 weeks). To measure the status of periopathogens, 3ml of saliva will be collected from each subject.
42 patients between 18 to 25 years old who have a periodontal probing depth of 3 mm or less will be recruited. To establish the baseline, all the patients will receive dental hygiene service.
After 2 weeks (Visit 1), patients will be randomly assigned to either control or intervention group (21 individuals each). They will be asked to do the following instruction; Control group (21 total) - The individuals in the control group will be asked to brush their teeth once a day at home throughout the 4 weeks of study period. They will be asked not to use the supplementary oral hygiene products including mouth rinse, dental floss and chewing gum.
Experimental/Intervention group (21 total) - The individuals in this group will be asked to brush their teeth once a day at home throughout the 4 weeks of study period. They will be asked not to use the supplementary oral hygiene products including mouth rinse, dental floss and chewing gum. Instead, they will be asked to come to the clinic to use COMORAL® three times a day, every day except Saturday and Sunday.
Subjects in both groups will be evaluated for clinical indices (PI, BOP, GI, PD, GR, CAL) and the status of periopathogens on visit 1(baseline, visit 2(after 2 weeks), and visit 3(after 4 weeks). To measure the status of periopathogens, 3ml of saliva will be collected from each subject.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: