Clinical Trials Logo

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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT05031260
Study type Interventional
Source University of California, Los Angeles
Contact Reuben Kim, DDS, PhD
Phone (310) 825-7312
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date October 1, 2021
Completion date June 30, 2022

See also
  Status Clinical Trial Phase
Not yet recruiting NCT04634201 - Effect of Probiotics on the Periodontal Status of Orthodontic Patients N/A
Completed NCT02552589 - Effect of Toothpaste on the Reduction of Plaque and Inflammation N/A
Completed NCT02884817 - Essential Oil+ELA, Plaque and Gingivitis Phase 4
Completed NCT02633345 - Effects on Tablets Containing Probiotic Candidate Strains N/A
Completed NCT02980497 - Antiplaque/Antigingivitis Efficacy of Essential Oil Mouthrinses in Six-Month Study N/A
Unknown status NCT01956656 - Efficacy Of Lotus Leaves In Management Of Plaque Induced Gingivitis N/A
Completed NCT02515929 - Prospective Double-Blind Randomized Controlled Clinical Trial in the Gingivitis Prevention With OPCs Phase 4
Completed NCT02235532 - Effects of Aloe Vera Toothpaste on Periodontal Parameters N/A
Completed NCT02508987 - Obesity and Oxidative Stress in Patients With Different Periodontal Status N/A
Completed NCT01941797 - Experimental Peri-implant Mucositis in Humans N/A
Unknown status NCT01197105 - Evaluation Study of a Mouthwash Based on Schinus Terebinthifolius to Treat Gingivitis in Children Phase 1/Phase 2
Completed NCT01593540 - Clinical Examination of Metal Free Interdental Brushes Phase 4
Completed NCT01236963 - Essential Oils Mouthrinse and Dental Floss, Comparison of Efficacy on Interproximal Gingivitis and Dental Plaque Accumulation N/A
Completed NCT02102295 - Effects of Antioxidant Dentifrice on Gingivitis Phase 3
Completed NCT02937636 - To Investigate the Gingivitis Efficacy of a Stannous Fluoride Dentifrice in a Chinese Population N/A
Completed NCT03641989 - Correlation Between Oral Health and Systemic Inflammation (COHESION) N/A
Not yet recruiting NCT04977778 - Effectiveness in Dental Plaque Reduction of Mouthwashes Containing Fatty Acids Compounds (F.A.G.) or Stannous Fluoride N/A
Recruiting NCT03928080 - Diagnostic Accuracy of Rapid Non-clinical Screening Tests for Early Detection of Periodontitis
Recruiting NCT03765125 - Dietary Collagen Peptides and Periodontal Inflammation N/A
Completed NCT05038540 - The Effect of Virtual Reality Glasses on Dental Anxiety Control N/A