Efficacy and Safety Evaluation of Jet Floss EX After 8-week Application

NCT06718959 | Completed

• 1 other identifier: 2024-287-KQ-026
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Bleeding on Probing; Plaque; Gingival Index

Keywords

Gingival index; Bleeding on Probing; Plaque

Outcome Measures

Primary Outcomes (3)

• 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.

  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).

  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) .

  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.

  8 weeks

• Compare the differences in PD (Probing Depth) between the test group and the control group after 8 weeks of uses.

  8 weeks

• Compare the differences in MGI (Modified Gingival Index) between the test group and the control group after 8 weeks of uses.

  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.

  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.

  8 weeks

Study Arms (2)

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.

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.

Other: the control product (interdental brush)

Interventions

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.

treatment group

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.

control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guang Dong Bixdo Health Technology Co.,Ltd: lead

Study Sites (1)

Beijing Sino-German Union Cosmetic Institute Co., Ltd.

Chaoyang District, Beijing Municipality, 100123, China

Location

MeSH Terms

Conditions

Plaque, Amyloid

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 5, 2024
• Study Start: April 9, 2024
• Primary Completion: June 17, 2024
• Study Completion: June 17, 2024
• Last Updated: December 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)