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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05031260
Other study ID # 20-001256
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 1, 2021
Est. completion date June 30, 2022

Study information

Verified date August 2021
Source University of California, Los Angeles
Contact Reuben Kim, DDS, PhD
Phone (310) 825-7312
Email rkim@dentistry.ucla.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 42
Est. completion date June 30, 2022
Est. primary completion date November 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 25 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Existing dental caries - Existing periodontitis - Other oral diseases

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of California, Los Angeles

Outcome

Type Measure Description Time frame Safety issue
Primary gingival index (GI) the scoring system for mild inflammation(modified gingival index) Baseline, 2 weeks, 4 weeks
Primary plaque index (PI) the amount of dental plaque visible on the vestibular and lingual surfaces Baseline, 2 weeks, 4 weeks
Primary bleeding on probing (BOP) the scoring system recorded 20 seconds after probing the depth of the pocket Baseline, 2 weeks, 4 weeks
Primary pocket depth (PD) the distance from the gingival margin to pocket base Baseline, 2 weeks, 4 weeks
Primary gingival recession (GR) the distance of the displacement of marginal gingiva apical to the cemento-enamel junction Baseline, 2 weeks, 4 weeks
Primary clinical attachment loss (CAL) the distance between the cementoenamel junction and the base of the probeable pocket Baseline, 2 weeks, 4 weeks
Secondary Periopathogens (PP) the amounts of s. mutans, p. gingivalis, and f. nucleatum. Baseline, 2 weeks, 4 weeks
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