Efficacy and Safety Evaluation of Jet Floss EX After 8-week Application

Efficacy and Safety Evaluation of Jet Floss EX

This was a single center, comparison among treatments, 8-week study of the efficacy and safety of Jet Floss EX.

Totally 72 eligible subjects were recruited in this study and randomly divided into 2 groups. During wash out phase (7 days before the study), subjects used distributed manual toothbrush and toothpaste every morning and evening to replace their own products. After that, subjects screened by dentist to ensure met the inclusion criteria. During treatment phase, for group1 (treatment group), subjects continued to use distributed manual toothbrush and toothpaste every morning and evening, and add used the test product (Jet Floss EX) twice a day. For group2 (control group), subjects continued to use distributed manual toothbrush and toothpaste every morning and evening, and add used auxiliary product (interdental brush) twice a day. During the study, any other oral care products and non-emergency oral treatment were not allowed.

Test Objective:To evaluate the efficacy and safety of test product by means of intraoral exams of BOP, PD, MGI, RMNPI, hard and soft tissues exams and selfassessment.

Study Overview

• Status: Completed
• Conditions: Plaque; Gingival Index; Bleeding on Probing
• Intervention / Treatment: Device: the test product (Jet Floss EX); Other: the control product (interdental brush)

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Chaoyang District, Beijing, China, 100123
      • Beijing Sino-German Union Cosmetic Institute Co., Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Chinese men or women aged 18-60 years old;
• In general good health at the time of the study;
• Possess a minimum of 20 scorable teeth;
• Each quadrant has ≥4 inter tooth gaps that can be inserted by interdental brush；
• RMNPI≥0.6;
• BOP≥50%;
• MGI≥1.75;
• PD≤5 mm;
• There were no diseases that will affect the test results;
• Willing and able to participate as evidenced by signing of informed consent;
• Willing to comply with all study protocol requirements.

Exclusion Criteria:

• Intending to get pregnant, pregnant, lactating or within 6 months of delivery;
• Those who have known allergies against oral care product or have severe oral disease;
• Simultaneous participating in another oral study;
• Have any fixed facial orthodontic appliances or removable partial dentures;
• Severe presence of tartar or stain which will affect the test;
• Others whose participation in the study is determined inappropriate by the dentist.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: treatment group; subjects continued to use distributed manual toothbrush and toothpaste every morning and evening, and add used the test product (Jet Floss EX) twice a day.	Device: the test product (Jet Floss EX); subjects continued to use distributed manual toothbrush and toothpaste every morning and evening, and add used the test product (Jet Floss EX) twice a day. Subjects used the test product (standard sprinkler, water twice) to flush all gingival margins and adjacent spaces with 440ml of water, start with water pressure gear 1 for the first time and continued with this gear after reaching the highest level that can be asapted. If felt uncomfortable, eligible subjects can adjust it to a suitable gear. The specific installation and usage of the teeth punch refer to the product instruction.
Active Comparator: control group; subjects continued to use distributed manual toothbrush and toothpaste every morning and evening, and add auxiliary product (interdental brush) twice a day.	Other: the control product (interdental brush); subjects continued to use distributed manual toothbrush and toothpaste every morning and evening, and add auxiliary product (interdental brush) twice a day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The improvement in BOP(Bleeding on Probing) after 8 weeks of use.	After 8 weeks of treatment, when compared with the baseline, reduction percentage in the bleeding index.	8 weeks
The improvement in MGI (Modified Gingival Index) after 8 weeks of use.	After 8 weeks of treatment, when compared with the baseline, reduction percentage in MGI (Modified Gingival Index).	8 weeks
The improvement in RMNPI (Rustogi Modification of the Navy Plaque Index) after 8 weeks of use.	After 8 weeks of treatment, when compared with the baseline, reduction percentage in RMNPI (Rustogi Modification of the Navy Plaque Index) .	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare the differences in BOP(Bleeding on Probing) between the test group and the control group after 8 weeks of uses.	Dentists evaluate the bleeding index of all study participants according to the BOP (Bleeding on Probing) evaluation criteria using CPI (Community Periodontal Index) probes. The scoring criteria are: 0= no bleeding, 1= bleeding. Calculate the percentage of sites that bleed after probing out of the total number of sites evaluated. The effectiveness of the water flosser(Jet Floss EX) in the test group will be analyzed by comparing the bleeding index with that of the interdental brush in the control group to determine if there are significant intergroup differences.	8 weeks
Compare the differences in PD (Probing Depth) between the test group and the control group after 8 weeks of uses.	Dentists evaluate the PD periodontal probing depth for all study participants. Measure the distance from the gingival margin to the bottom of the pocket on the buccal and lingual aspects at the distal, central, and mesial sites, recording six sites per tooth. Calculate the average value. The effectiveness of the water flosser(Jet Floss EX) in the test group will be analyzed by comparing the PD (Probing Depth) with that of the interdental brush in the control group to determine if there are significant intergroup differences.	8 weeks
Compare the differences in MGI (Modified Gingival Index) between the test group and the control group after 8 weeks of uses.	Dentists score the gingival condition of all study participants based on the modified gingival index criteria. Examine and record the MGI score on the buccal and lingual aspects at the distal, central, and mesial sites of teeth, calculate the average value. The effectiveness of the water flosser(Jet Floss EX) in the test group will be analyzed by comparing the PD (Probing Depth) with that of the interdental brush in the control group to determine if there are significant intergroup differences.	8 weeks
Compare the differences in RMNPI (Rustogi Modification of the Navy Plaque Index) between the test group and the control group after 8 weeks of uses.	Dentists evaluate the plaque condition of all study participants based on the RMNPI Modified Plaque Index using visual inspection. Participants should stain their teeth with a disclosing agent before evaluation. The teeth are divided into nine regions A-I, and plaque is scored for each region (buccal and lingual aspects of regions A-I), with the scoring criteria being: 0= no plaque; 1= plaque present. Calculate the average value. The effectiveness of the water flosser(Jet Floss EX) in the test group will be analyzed by comparing the PD (Probing Depth) with that of the interdental brush in the control group to determine if there are significant intergroup differences.	8 weeks
Evaluate the safety of the test product(Jet Floss EX) by conducting an examination and assessment of the oral soft and hard tissues after 8 weeks of uses.	Dentists will conduct an assessment of the oral soft and hard tissues for all study participants. This examination includes the inspection of the soft palate, hard palate, gingival mucosa, buccal mucosa, mucogingival fold area, tongue, sublingual and submandibular regions, salivary glands, tonsils, and the pharyngeal area.The scoring criteria are: 0= normal, 1= unnormal.	8 weeks
Subject satisfaction evaluation	The participants received a questionnaire at the last visit, which mainly included the improvement effect of the product.	8 weeks

Collaborators and Investigators

• Sponsor: Guang Dong Bixdo Health Technology Co.,Ltd

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2024
• Primary Completion (Actual): June 17, 2024
• Study Completion (Actual): June 17, 2024

Study Registration Dates

• First Submitted: November 26, 2024
• First Submitted That Met QC Criteria: December 2, 2024
• First Posted (Estimated): December 5, 2024

Study Record Updates

• Last Update Posted (Estimated): December 5, 2024
• Last Update Submitted That Met QC Criteria: December 2, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Plaque; Gingival index; Bleeding on Probing
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: 2024-287-KQ-026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No