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