Efficacy and Safety Evaluation of Jet Floss EX After 8-week Application (NCT06718959) | Clinical Trial Compass
CompletedNot Applicable
Efficacy and Safety Evaluation of Jet Floss EX After 8-week Application
China72 participantsStarted 2024-04-09
Plain-language summary
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.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The improvement in BOP(Bleeding on Probing) after 8 weeks of use.
Timeframe: 8 weeks
2
The improvement in MGI (Modified Gingival Index) after 8 weeks of use.
Timeframe: 8 weeks
3
The improvement in RMNPI (Rustogi Modification of the Navy Plaque Index) after 8 weeks of use.