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A randomized, single-blind, parallel-controlled clinical trial on the efficacy and safety of Jiebi dental irrigator in the control of plaque and gingivitis

A randomized, single-blind, parallel-controlled clinical trial on the efficacy and safety of Jiebi dental irrigator in the control of plaque and gingivitis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100054254
Enrollment
Unknown
Registered
2021-12-11
Start date
2021-10-22
Completion date
Unknown
Last updated
2022-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gingivitis

Interventions

Group 1:Jiebi dental irrigator (GT-17)
Group 2:None

Sponsors

West China School of Stomatology, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 65 years, gender is not limited; 2. The whole body is in good health; 3. Have the habit of brushing your teeth daily; 4. There are more than 20 detectable natural teeth (except third molars), and there are at least 5 natural teeth in each quadrant; 5. Subjects with gingivitis, check at least 20 gingival bleeding sites; 6. Turesky modified Quigley-Hein plaque index PI >= 1.5; 7. Sign the informed consent and be able to complete the clinical trial as required.

Exclusion criteria

Exclusion criteria: 1. A history of periodontitis or gingival recession; 2. Wearing orthodontic rings or orthodontic appliances; 3. Wearing removable dentures or poor restorations; 4. There are open caries, mucosal lesions, soft and hard tissue tumors in the oral cavity; 5. Received periodontal treatment within 6 months before the start of the visit; 6. Received oral surgery within 3 months before the start of the visit; 7. Received professional scaling within 4 weeks before the start of the visit; 8. Participated in other clinical studies within 3 months before the start of the visit; 9. Equipped with a pacemaker or defibrillator; 10. Patients with dry mouth; 11. Antibiotics, non-steroidal anti-inflammatory drugs or traditional Chinese medicines are required to be used during or during screening; 12. Take anticoagulant drugs; 13. Use tooth whitening products or oral cleaning auxiliary products (such as: oral irrigator, electric toothbrush, dental floss, interdental brush, mouthwash, etc.); 14. Those who are known or suspected to be allergic or intolerable to the materials used or their components; 15. Patients planning to become pregnant, pregnant or breastfeeding within the past 1 year; 16. Dental students or dental professionals; 17. Employees or family members of the clinical research department of the Research Center, the School of Dentistry or the company that manufactures, researches or markets dental products; 18. Smoking cigarettes, or any electronic cigarette products, pipes or cigars; 19. Suffering from severe systemic diseases (such as hypertension, diabetes, abnormal liver and kidney function, etc. that affect existing periodontal diseases); 20. The researcher believes that his general and oral condition is not suitable for the subjects participating in this study.

Design outcomes

Primary

MeasureTime frame
Modified Gingival Index;Bleeding index;Bleeding on probing;

Secondary

MeasureTime frame
Modified Plaque Index;

Countries

China

Contacts

Public ContactCheng Li

West China School of Stomatology, Sichuan University

24925685@qq.com+86 15882453615

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026