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NCT06718959

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

Completed NA Last updated 5 December 2024
What this trial tests

NA trial testing the test product (Jet Floss EX) in Bleeding on Probing in 72 participants. Completed in 17 June 2024.

Timeline
9 April 2024
Primary endpoint
17 June 2024
17 June 2024

Quick facts

Lead sponsorGuang Dong Bixdo Health Technology Co.,Ltd
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment72
Start date9 April 2024
Primary completion17 June 2024
Estimated completion17 June 2024
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Guang Dong Bixdo Health Technology Co.,Ltd

Who can join

Adults 18 to 60, any sex, with Bleeding on Probing or Plaque. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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