COMORAL® the Oral Irrigation Unit Clinical Trial

NCT05031260 | Not Yet Recruiting

• 1 other identifier: 20-001256
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Gingivitis; Plaque

Keywords

COMORAL; the oral irrigation unit

Outcome Measures

Primary Outcomes (6)

• gingival index (GI)

  the scoring system for mild inflammation(modified gingival index)

  Baseline, 2 weeks, 4 weeks

• plaque index (PI)

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

  Baseline, 2 weeks, 4 weeks

• bleeding on probing (BOP)

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

  Baseline, 2 weeks, 4 weeks

• pocket depth (PD)

  the distance from the gingival margin to pocket base

  Baseline, 2 weeks, 4 weeks

• gingival recession (GR)

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

  Baseline, 2 weeks, 4 weeks

• clinical attachment loss (CAL)

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

  Baseline, 2 weeks, 4 weeks

Secondary Outcomes (1)

• Periopathogens (PP)

  Baseline, 2 weeks, 4 weeks

Study Arms (2)

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.

Device: applying COMORAL®

Interventions

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.

Experimental group

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Existing dental caries
• Existing periodontitis
• Other oral diseases

Sponsors & Collaborators

• University of California, Los Angeles: lead

MeSH Terms

Conditions

Gingivitis; Plaque, Amyloid

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Reuben Kim, DDS, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Reuben Kim, DDS, PhD

CONTACT

(310) 825-7312; rkim@dentistry.ucla.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair

Study Record Dates

• First Submitted: July 20, 2021
• First Posted: September 1, 2021
• Study Start: October 1, 2021
• Primary Completion: November 30, 2021
• Study Completion: June 30, 2022
• Last Updated: September 1, 2021

Record last verified: 2021-08