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Evaluation of the efficacy and safety of Pudilan Keyanning bacteriostatic mouthrinse in inhibiting dental plaque and reducing gingival inflammation

Evaluation of the efficacy and safety of Pudilan Keyanning bacteriostatic mouthrinse in inhibiting dental plaque and reducing gingival inflammation

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000041253
Enrollment
Unknown
Registered
2020-12-23
Start date
2020-12-25
Completion date
Unknown
Last updated
2021-03-08

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

Conditions

Gingivitis

Interventions

Test group:using 0.12% chlorhexidine acetate mouthrinse
Control group 1:using 0.12% chlorhexidine acetate mouthrinse
Control group 1:using mouthrinse without effective traditional Chinese medicine ingredient. The rest of formula is as same as the Pudilan Keyanning bacteriostatic mouthrinse

Sponsors

Peking University School of Stomatology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-65 years; 2. In good genenral health; 3. Having the habit of brushing teeth every day, with more than 20 teeth for evaluation except the third molar; 4. No more than 5 residual deep periodontal pockets (pockets presenting PD >= 6 mm due to the patient's refusal of surgical treatment); 5. No intraoral mucosal damage; 6. Signing the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Hepatitis, tuberculosis and other infectious diseases; 2. Poor control of systemic diseases such as hypertension, heart disease, diabetes and so on; 3. Acute gingival inflammation; 4. Open caries; 5. Removable dentures or fixed orthodontic devices in the mouth; 6. Pregnancy or lactating women; 7. Smoking; 8. Used antibiotics within 3 months; 9. Used any mouthrinse within 1 month.

Design outcomes

Primary

MeasureTime frame
Plaque Index;Gingiva Index;Probing depth;Bleeding Index;

Secondary

MeasureTime frame
Breath;microbial characteristics of subgingival plaque;

Countries

China

Contacts

Public ContactOuyang Xiangying

Peking University School of Stomatology

kqouyangxy@126.com+86 13621050102

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 14, 2026