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COMORAL® the Oral Irrigation Unit Clinical Trial

ConditionsGingivitisPlaque
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-25
SponsorUniversity of California, Los Angeles

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Existing dental caries

Existing periodontitis

Other oral diseases

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

42 Participants
are divided into 2 treatment groups
Group A: Control groupNo intervention 0 interventions
Group B: Experimental groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

gingival index (GI)

the scoring system for mild inflammation(modified gingival index)

Time frame
Baseline, 2 weeks, 4 weeks
2

plaque index (PI)

the amount of dental plaque visible on the vestibular and lingual surfaces

Time frame
Baseline, 2 weeks, 4 weeks
3

bleeding on probing (BOP)

the scoring system recorded 20 seconds after probing the depth of the pocket

Time frame
Baseline, 2 weeks, 4 weeks
4

pocket depth (PD)

the distance from the gingival margin to pocket base

Time frame
Baseline, 2 weeks, 4 weeks

Secondary outcomes

1

Periopathogens (PP)

the amounts of s. mutans, p. gingivalis, and f. nucleatum.

Time frame
Baseline, 2 weeks, 4 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, Los Angeles

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: