Efficacy and Safety Evaluation of Jet Floss EX After 8-week Application
NCT ID: NCT06718959
Last Updated: 2024-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
72 participants
INTERVENTIONAL
2024-04-09
2024-06-17
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
control group
subjects continued to use distributed manual toothbrush and toothpaste every morning and evening, and add auxiliary product (interdental brush) twice a day.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Guang Dong Bixdo Health Technology Co.,Ltd
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Beijing Sino-German Union Cosmetic Institute Co., Ltd.
Chaoyang District, Beijing Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024-287-KQ-026
Identifier Type: -
Identifier Source: org_study_id