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NCT05031260Not yet recruiting

COMORAL® the Oral Irrigation Unit Clinical Trial

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

Source: ClinicalTrials.gov · Last updated 1 Sept 2021 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
42 (estimated)
First submitted
20 Jul 2021
Start date
1 Oct 2021
Primary completion date
30 Nov 2021
Lead sponsor
University of California, Los Angeles
NCT number
NCT05031260

What you commit to

  • Study type: Interventional
  • Planned participants: 42
  • From 1 Oct 2021 to the primary completion date, 30 Nov 2021
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Other oral diseases

Other

  • Existing dental caries
  • Existing periodontitis

Who the study is looking for

  • 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

Age in the registry: 18 years to 25 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.