COMORAL® the Oral Irrigation Unit Clinical Trial

Gingivitis Clinical Trial

— COMORAL  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05031260
• Other study ID #: 20-001256
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Gingivitis
• Plaque

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