NCT06718959

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

Efficacy and Safety Evaluation of Jet Floss EX

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Guang Dong Bixdo Health Technology Co.,Ltd · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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. 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.
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.

Timeline

• Start date: 2024-04-09
• Primary completion: 2024-06-17
• Completion: 2024-06-17
• First posted: 2024-12-05
• Last updated: 2024-12-05

Locations

1 site across 1 country: China