Clinical trial NCT06718959: Efficacy and Safety Evaluation of Jet Floss EX After 8-week Application
Official title: Efficacy and Safety Evaluation of Jet Floss EX
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bleeding on Probing
Plaque
Gingival Index
Keywords: Gingival index
Bleeding on Probing
Plaque
Lead sponsor: Guang Dong Bixdo Health Technology Co.,Ltd
Sponsor class: OTHER
First posted: 2024-12-05
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: The improvement in BOP(Bleeding on Probing) after 8 weeks of use.
timeFrame: 8 weeks
measure: The improvement in MGI (Modified Gingival Index) after 8 weeks of use.
timeFrame: 8 weeks
measure: The improvement in RMNPI (Rustogi Modification of the Navy Plaque Index) after 8 weeks of use.
timeFrame: 8 weeks
Secondary outcomes:
measure: Compare the differences in BOP(Bleeding on Probing) between the test group and the control group after 8 weeks of uses.
timeFrame: 8 weeks
measure: Compare the differences in PD (Probing Depth) between the test group and the control group after 8 weeks of uses.
timeFrame: 8 weeks
measure: Compare the differences in MGI (Modified Gingival Index) between the test group and the control group after 8 weeks of uses.
timeFrame: 8 weeks
measure: 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.
timeFrame: 8 weeks
measure: 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.
timeFrame: 8 weeks
measure: Subject satisfaction evaluation
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Chaoyang District
country: China
facility: Beijing Sino-German Union Cosmetic Institute Co., Ltd.
state: Beijing
Study officials:
References: