COMORAL® the Oral Irrigation Unit Clinical Trial (COMORAL)

Effect of COMORAL® the Oral Irrigation Unit in Preventing Gingivitis and Plaque Formation

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Gingivitis; Plaque
• Intervention / Treatment: Device: applying COMORAL®

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.

• Study Type: Interventional
• Enrollment (Anticipated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Reuben Kim, DDS, PhD; Phone Number: (310) 825-7312; Email: rkim@dentistry.ucla.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; The individuals in the control group will be asked to brush their teeth (2x per 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: Experimental group; The individuals in this group will be asked to brush their teeth (2x per 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
gingival index (GI)	the scoring system for mild inflammation(modified gingival index)	Baseline, 2 weeks, 4 weeks
plaque index (PI)	the amount of dental plaque visible on the vestibular and lingual surfaces	Baseline, 2 weeks, 4 weeks
bleeding on probing (BOP)	the scoring system recorded 20 seconds after probing the depth of the pocket	Baseline, 2 weeks, 4 weeks
pocket depth (PD)	the distance from the gingival margin to pocket base	Baseline, 2 weeks, 4 weeks
gingival recession (GR)	the distance of the displacement of marginal gingiva apical to the cemento-enamel junction	Baseline, 2 weeks, 4 weeks
clinical attachment loss (CAL)	the distance between the cementoenamel junction and the base of the probeable pocket	Baseline, 2 weeks, 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Periopathogens (PP)	the amounts of s. mutans, p. gingivalis, and f. nucleatum.	Baseline, 2 weeks, 4 weeks

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Investigators: Principal Investigator: Reuben Kim, DDS, PhD, University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2021
• Primary Completion (Anticipated): November 30, 2021
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: July 20, 2021
• First Submitted That Met QC Criteria: August 26, 2021
• First Posted (Actual): September 1, 2021

Study Record Updates

• Last Update Posted (Actual): September 1, 2021
• Last Update Submitted That Met QC Criteria: August 26, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: COMORAL; the oral irrigation unit
• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Gingivitis
• Other Study ID Numbers: 20-001256

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No