COMORAL® the Oral Irrigation Unit Clinical Trial

Study Overview
=================
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.

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

Conditions
-----------------
Gingivitis, Plaque

Intervention / Treatment
-----------------
* Device: applying COMORAL®


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>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<br>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®<br>* 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.<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COMORAL, the oral irrigation unit