Clinical trial NCT05031260: COMORAL® the Oral Irrigation Unit Clinical Trial
Official title: Effect of COMORAL® the Oral Irrigation Unit in Preventing Gingivitis and Plaque Formation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gingivitis
Plaque
Keywords: COMORAL
the oral irrigation unit
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2021-09-01
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: gingival index (GI)
timeFrame: Baseline, 2 weeks, 4 weeks
measure: plaque index (PI)
timeFrame: Baseline, 2 weeks, 4 weeks
measure: bleeding on probing (BOP)
timeFrame: Baseline, 2 weeks, 4 weeks
measure: pocket depth (PD)
timeFrame: Baseline, 2 weeks, 4 weeks
measure: gingival recession (GR)
timeFrame: Baseline, 2 weeks, 4 weeks
measure: clinical attachment loss (CAL)
timeFrame: Baseline, 2 weeks, 4 weeks
Secondary outcomes:
measure: Periopathogens (PP)
timeFrame: Baseline, 2 weeks, 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of California, Los Angeles
name: Reuben Kim, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: