Oral cleaning effect with Jet Floss

JRCT ID: jRCT1060240015

Registered date:21/05/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Periodontitis or Peri-implantitis
• Date of first enrollment: 21/05/2024
• Target sample size: 60
• Study type: Interventional

Intervention(s)

Distribution of Jet Floss Compacts and designated Toothpaste
For use, in addition to daily brushing twice a day at home, cleaning with the test product Jet Floss Compact for 2 to 3 minutes (until 600ml of water in the product is used up) or using a rubber interdental brush. Continue use for 4 weeks

Outcome(s)

Primary Outcome

1. Subjects with periodontitis
Measure the following items in a detailed periodontal tissue examination (6-points method).
1) PPD (Periodontal Probing Depth)
2) BOP (Bleeding on Probing)
3) PCR (Plaque Control Record)
Oral bacteria level
Plaque is collected from periodontal pockets using a rubber interdental brush-like sample collection tool, and the amount of periodontal pathogenic bacteria is evaluated using the PCR-based periodontal pathogenic bacteria detection device (Orcoa) and the (Orcoa oral bacteria detection kit: Orcoa Corporation).
Biomarker detection in saliva, gingival crevicular fluid, and peri-implant crevicular fluid
Saliva, gingival crevicular fluid, and peri-implant crevicular fluid were collected at the start and end of the study (4 weeks after the start), and changes in biomarkers such as inflammatory cytokines related to periodontitis before and after the intervention were measured using ELISA method.
2. Subjects with peri-implantitis
In addition to the measurement method used for subjects with periodontitis described above, the following will be measured.
The amount of biofilm on the base of the superstructure before and after using the Jet Floss is calculated using the following formula by taking standard photographs using the manufactured superstructure fixing device.
PCR (%) before and after Jet Floss = area of plaque staining area / (area of basal surface of implant superstructure - area of platform) multiplied by 100
PCR change rate (%) = (PCR before brushing - PCR after brushing) / PCR value before brushing multiplied by 100
Additionally, those who have used the Jet Floss fill out a questionnaire. The questions are as follows.
What did you think about the feeling of using the Jet Floss (or rubber interdental brush), pain after use, awareness of the plaque removal effect, cleaning time, etc.

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: < 65age old
• Gender: Both

Include criteria

Applicants must meet all of the following criteria.
1) Periodontal Probing Depth (PPD): less than 6 mm, Positive Bleeding on Probing (BOP), Plaque Control Record (PCR): 40% or more, Person with 10 or more remaining teeth
2) Those who have redness and swelling in the mucosa around the implant (peri-implant mucositis), and who also have pathological bone resorption in the implant-supporting bone on dental X-rays (peri-implantitis).
3) Patients who have received sufficient explanation and informed written consent of their own free will to participate in this study.

Exclude criteria

Patients who fall under any of the following will not be included in this study.
1) Those who are prescribed drugs (anti-allergic drugs, antibiotics, anti-inflammatory analgesics, etc.) that may affect the judgment of the test.
2) Persons suffering from serious oral diseases (caries, periodontal diseases, etc.) and persons receiving treatment for these diseases.
3) Persons suffering from systemic diseases (liver disease, cardiovascular disease, etc.) or those receiving treatment for these diseases.
4) Other patients who are judged by the principal investigator or co-investigator to be unsuitable as research subjects.
5) Person who is a smoker
6) Currently pregnant.
7) Persons with specialized knowledge regarding oral hygiene (dental school students, faculty members, etc.)
[Rationale for setting] Because of the impact on effectiveness evaluation

Related Information

• Primary Sponsor: Hiromichi Yumoto
• Source(s) of Monetary Support: YA-MAN LTD.