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

Guang Dong Bixdo Health Technology Co.,Ltd

Status: Completed

Conditions: Bleeding on Probing; Plaque; Gingival Index

Treatments: Other: the control product (interdental brush); Device: the test product (Jet Floss EX)

Study type: Interventional

Funder types: Other

Identifiers

NCT06718959

2024-287-KQ-026

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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72 participants in 2 patient groups

treatment group

Experimental group

Description:

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.

Treatment:

Device: the test product (Jet Floss EX)

control group

Active Comparator group

Description:

subjects continued to use distributed manual toothbrush and toothpaste every morning and evening, and add auxiliary product (interdental brush) twice a day.

Treatment:

Other: the control product (interdental brush)