Bleeding on ProbingNCT06718959
Efficacy and Safety Evaluation of Jet Floss EX After 8-week Application
A study testing the test product (Jet Floss EX) in people with Bleeding on Probing and Plaque, run by Guang Dong Bixdo Health Technology Co.,Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bleeding on Probing, Plaque, Gingival Index
- What is being tested?
- the test product (Jet Floss EX)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 9 Apr 2024to 17 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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%;
Show all 11Show fewer
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site
Beijing Sino-German Union Cosmetic Institute Co., Ltd.
Chaoyang District, Beijing Municipality, 100123
About this study
Official title: Efficacy and Safety Evaluation of Jet Floss EX
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.
- Conditions
- Bleeding on Probing, Plaque, Gingival Index
- Being tested
- the test product (Jet Floss EX), the control product (interdental brush)
- Keywords
- Gingival index, Bleeding on Probing, Plaque
- Medical subject headings
- Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the test product (Jet Floss EX)Device
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.
the control product (interdental brush)Other
subjects continued to use distributed manual toothbrush and toothpaste every morning and evening, and add auxiliary product (interdental brush) twice a day.
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | 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. Receives: Device: the test product (Jet Floss EX) |
| control group | Active comparator | subjects continued to use distributed manual toothbrush and toothpaste every morning and evening, and add auxiliary product (interdental brush) twice a day. Receives: Other: the control product (interdental brush) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The improvement in BOP(Bleeding on Probing) after 8 weeks of use.
After 8 weeks of treatment, when compared with the baseline, reduction percentage in the bleeding index.
Measured: 8 weeks
The improvement in MGI (Modified Gingival Index) after 8 weeks of use.
After 8 weeks of treatment, when compared with the baseline, reduction percentage in MGI (Modified Gingival Index).
Measured: 8 weeks
The improvement in RMNPI (Rustogi Modification of the Navy Plaque Index) after 8 weeks of use.
After 8 weeks of treatment, when compared with the baseline, reduction percentage in RMNPI (Rustogi Modification of the Navy Plaque Index) .
Measured: 8 weeks
Secondary outcomes (6)
Compare the differences in BOP(Bleeding on Probing) between the test group and the control group after 8 weeks of uses.
Dentists evaluate the bleeding index of all study participants according to the BOP (Bleeding on Probing) evaluation criteria using CPI (Community Periodontal Index) probes. The scoring criteria are: 0= no bleeding, 1= bleeding. Calculate the percentage of sites that bleed after probing out of the total number of sites evaluated.
The effectiveness of the water flosser(Jet Floss EX) in the test group will be analyzed by comparing the bleeding index with that of the interdental brush in the control group to determine if there are significant intergroup differences.
Measured: 8 weeks
Compare the differences in PD (Probing Depth) between the test group and the control group after 8 weeks of uses.
Dentists evaluate the PD periodontal probing depth for all study participants. Measure the distance from the gingival margin to the bottom of the pocket on the buccal and lingual aspects at the distal, central, and mesial sites, recording six sites per tooth. Calculate the average value.
The effectiveness of the water flosser(Jet Floss EX) in the test group will be analyzed by comparing the PD (Probing Depth) with that of the interdental brush in the control group to determine if there are significant intergroup differences.
Measured: 8 weeks
Compare the differences in MGI (Modified Gingival Index) between the test group and the control group after 8 weeks of uses.
Dentists score the gingival condition of all study participants based on the modified gingival index criteria.
Examine and record the MGI score on the buccal and lingual aspects at the distal, central, and mesial sites of teeth, calculate the average value.
The effectiveness of the water flosser(Jet Floss EX) in the test group will be analyzed by comparing the PD (Probing Depth) with that of the interdental brush in the control group to determine if there are significant intergroup differences.
Measured: 8 weeks
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.
Dentists evaluate the plaque condition of all study participants based on the RMNPI Modified Plaque Index using visual inspection.
Participants should stain their teeth with a disclosing agent before evaluation.
The teeth are divided into nine regions A-I, and plaque is scored for each region (buccal and lingual aspects of regions A-I), with the scoring criteria being: 0= no plaque; 1= plaque present. Calculate the average value.
The effectiveness of the water flosser(Jet Floss EX) in the test group will be analyzed by comparing the PD (Probing Depth) with that of the interdental brush in the control group to determine if there are significant intergroup differences.
Measured: 8 weeks
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.
Dentists will conduct an assessment of the oral soft and hard tissues for all study participants. This examination includes the inspection of the soft palate, hard palate, gingival mucosa, buccal mucosa, mucogingival fold area, tongue, sublingual and submandibular regions, salivary glands, tonsils, and the pharyngeal area.The scoring criteria are: 0= normal, 1= unnormal.
Measured: 8 weeks
Subject satisfaction evaluation
The participants received a questionnaire at the last visit, which mainly included the improvement effect of the product.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start9 Apr 2024
- Primary completion17 Jun 2024
- Study completion17 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bleeding on ProbingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guang Dong Bixdo Health Technology Co.,Ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06718959
- Sponsor's protocol ID
- 2024-287-KQ-026
- Status last verified
- Nov 2024
- First submitted
- 26 Nov 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Evaluation of Jet Floss EX
- ClinicalTrials.gov ID
- NCT06718959
- Acronym / sponsor ID
- 2024-287-KQ-026
- Conditions
- Bleeding on Probing, Plaque, Gingival Index
- Keywords
- Gingival index, Bleeding on Probing, Plaque
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Guang Dong Bixdo Health Technology Co.,LtdUniversity, hospital or other
- Study start
- 9 Apr 2024 (actual)
- Primary completion
- 17 Jun 2024 (actual)
- Study completion
- 17 Jun 2024 (actual)
- First posted
- 5 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Device: 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. |
| control group | Active comparator | Other: 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | treatment group |
| 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. | Other | control group |
Primary outcome
The improvement in BOP(Bleeding on Probing) after 8 weeks of use.
Time frame: 8 weeks
After 8 weeks of treatment, when compared with the baseline, reduction percentage in the bleeding index.
The improvement in MGI (Modified Gingival Index) after 8 weeks of use.
Time frame: 8 weeks
After 8 weeks of treatment, when compared with the baseline, reduction percentage in MGI (Modified Gingival Index).
The improvement in RMNPI (Rustogi Modification of the Navy Plaque Index) after 8 weeks of use.
Time frame: 8 weeks
After 8 weeks of treatment, when compared with the baseline, reduction percentage in RMNPI (Rustogi Modification of the Navy Plaque Index) .
6 secondary outcomes
Compare the differences in BOP(Bleeding on Probing) between the test group and the control group after 8 weeks of uses.
Time frame: 8 weeks
Compare the differences in PD (Probing Depth) between the test group and the control group after 8 weeks of uses.
Time frame: 8 weeks
Compare the differences in MGI (Modified Gingival Index) between the test group and the control group after 8 weeks of uses.
Time frame: 8 weeks
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.
Time frame: 8 weeks
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.
Time frame: 8 weeks
Subject satisfaction evaluation
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the test product (Jet Floss EX) in people with Bleeding on Probing and Plaque, run by Guang Dong Bixdo Health Technology Co.,Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The improvement in BOP(Bleeding on Probing) after 8 weeks of use. (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.