GingivitisCOMORALNCT05031260
COMORAL® the Oral Irrigation Unit Clinical Trial
A study testing applying COMORAL® in people with Gingivitis and Plaque, run by University of California, Los Angeles.
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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis, Plaque
- What is being tested?
- applying COMORAL®
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2021to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Existing dental caries
- Existing periodontitis
- Other oral diseases
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of COMORAL® the Oral Irrigation Unit in Preventing Gingivitis and Plaque Formation
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.
Read the 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.
- Conditions
- Gingivitis, Plaque
- Being tested
- applying COMORAL®
- Keywords
- COMORAL, the oral irrigation unit
- Medical subject headings
- Gingivitis, Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
applying COMORAL®Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | 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 group | Experimental | 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. Receives: Device: applying COMORAL® |
What is being measured
The primary outcome is the main question the study is designed to answer.
gingival index (GI)
the scoring system for mild inflammation(modified gingival index)
Measured: Baseline, 2 weeks, 4 weeks
plaque index (PI)
the amount of dental plaque visible on the vestibular and lingual surfaces
Measured: Baseline, 2 weeks, 4 weeks
bleeding on probing (BOP)
the scoring system recorded 20 seconds after probing the depth of the pocket
Measured: Baseline, 2 weeks, 4 weeks
pocket depth (PD)
the distance from the gingival margin to pocket base
Measured: Baseline, 2 weeks, 4 weeks
gingival recession (GR)
the distance of the displacement of marginal gingiva apical to the cemento-enamel junction
Measured: Baseline, 2 weeks, 4 weeks
clinical attachment loss (CAL)
the distance between the cementoenamel junction and the base of the probeable pocket
Measured: Baseline, 2 weeks, 4 weeks
Secondary outcomes (1)
Periopathogens (PP)
the amounts of s. mutans, p. gingivalis, and f. nucleatum.
Measured: Baseline, 2 weeks, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start1 Oct 2021 (estimated)
- Primary completion30 Nov 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reuben Kim, DDS, PhD, University of California, Los Angeles
- Investigators
- Reuben Kim, DDS, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05031260
- Sponsor's protocol ID
- 20-001256
- Acronym
- COMORAL
- Status last verified
- Aug 2021
- First submitted
- 20 Jul 2021
- Last updated
- 1 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of COMORAL® the Oral Irrigation Unit in Preventing Gingivitis and Plaque Formation
- ClinicalTrials.gov ID
- NCT05031260
- Acronym / sponsor ID
- COMORAL / 20-001256
- Conditions
- Gingivitis, Plaque
- Keywords
- COMORAL, the oral irrigation unit
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 1 Oct 2021 (estimated)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 1 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –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 group | Experimental | Device: applying COMORAL®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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Existing dental caries
- Existing periodontitis
- Other oral diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Experimental group |
Primary outcome
gingival index (GI)
Time frame: Baseline, 2 weeks, 4 weeks
the scoring system for mild inflammation(modified gingival index)
plaque index (PI)
Time frame: Baseline, 2 weeks, 4 weeks
the amount of dental plaque visible on the vestibular and lingual surfaces
bleeding on probing (BOP)
Time frame: Baseline, 2 weeks, 4 weeks
the scoring system recorded 20 seconds after probing the depth of the pocket
pocket depth (PD)
Time frame: Baseline, 2 weeks, 4 weeks
the distance from the gingival margin to pocket base
gingival recession (GR)
Time frame: Baseline, 2 weeks, 4 weeks
the distance of the displacement of marginal gingiva apical to the cemento-enamel junction
clinical attachment loss (CAL)
Time frame: Baseline, 2 weeks, 4 weeks
the distance between the cementoenamel junction and the base of the probeable pocket
1 secondary outcome
Periopathogens (PP)
Time frame: Baseline, 2 weeks, 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Reuben Kim, DDS, PhD principal investigator
University of California, Los Angeles
Questions about this trial
What is this clinical trial studying?
A study testing applying COMORAL® in people with Gingivitis and Plaque, run by University of California, Los Angeles.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reuben Kim, DDS, PhD ((310) 825-7312, rkim@dentistry.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gingival index (GI) (time frame: Baseline, 2 weeks, 4 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2021.