Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT05031260

COMORAL® the Oral Irrigation Unit Clinical 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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Gingivitis Gingival Diseases Infections Mouth Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Periodontal Diseases Plaque Plaque, Amyloid Stomatognathic Diseases

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. gingival index (GI)

    Time frame: Baseline, 2 weeks, 4 weeks

    the scoring system for mild inflammation(modified gingival index)

  2. plaque index (PI)

    Time frame: Baseline, 2 weeks, 4 weeks

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

  3. bleeding on probing (BOP)

    Time frame: Baseline, 2 weeks, 4 weeks

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

  4. pocket depth (PD)

    Time frame: Baseline, 2 weeks, 4 weeks

    the distance from the gingival margin to pocket base

  5. gingival recession (GR)

    Time frame: Baseline, 2 weeks, 4 weeks

    the distance of the displacement of marginal gingiva apical to the cemento-enamel junction

  6. clinical attachment loss (CAL)

    Time frame: Baseline, 2 weeks, 4 weeks

    the distance between the cementoenamel junction and the base of the probeable pocket

Secondary outcomes

  1. Periopathogens (PP)

    Time frame: Baseline, 2 weeks, 4 weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

Reuben Kim, DDS, PhD

CONTACT

[email protected]

(310) 825-7312

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Official study title

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

Acronym: COMORAL

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Sep 1, 2021
Registry last updated
Sep 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.