NCT06718959Completed
Efficacy and Safety Evaluation of Jet Floss EX After 8-week Application
Efficacy and Safety Evaluation of Jet Floss EX
Source: ClinicalTrials.gov · Last updated 5 Dec 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 72 (actual)
- First submitted
- 26 Nov 2024
- Start date
- 9 Apr 2024
- Primary completion date
- 17 Jun 2024
- Lead sponsor
- Guang Dong Bixdo Health Technology Co.,Ltd
- NCT number
- NCT06718959
What you commit to
- Study type: Interventional
- Participants enrolled: 72
- From 9 Apr 2024 to the primary completion date, 17 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Those who have known allergies against oral care product or have severe oral disease;
Other
- Intending to get pregnant, pregnant, lactating or within 6 months of delivery;
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Sino-German Union Cosmetic Institute Co., Ltd. Coordinator of this site? Confirm its status | Chaoyang District | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.