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GUM Mouthwash clinical trial

A randomized, double-blind, parallel-controlled clinical trial evaluating the efficacy and safety of GUM Dental mouthwash for reducing gingival inflammation

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100054512
Enrollment
Unknown
Registered
2021-12-19
Start date
2021-12-15
Completion date
Unknown
Last updated
2022-11-28

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

Conditions

gingival inflammation

Interventions

Experimental group:GUM Dental mouthwash
Control group:Placebo

Sponsors

Affiliated Stomatological Hospital of Nanjing University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. There are more than 20 detectable teeth (including 11, 16, 17, 26, 27, 31, 36, 37, 46, 47, except the third molar); 2. Aged 20 to 70 years, and the gender is not limited; 3. Subjects should have an appropriate degree of gingivitis; BI (Bleeding Index Mazza, 1981) was enrolled with a baseline index value of 1.0-3.0; 4. Non-smokers (including e-cigarettes) (refers to those who have no smoking history or who have quit smoking); 5. Subjects voluntarily agreed to participate in this trial and signed the subject's informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients who are allergic or have a history of allergy to cetylpyridinium chloride (CPC), dipotassium glycyrrhizinate (GK2), tranexamic acid (TXA), and sodium fluoride (NaF); 2. Those who used antibiotics and other mouthwashes within one month before participating in the study; 3. Periodontal treatment within 3 months; 4. Patients with open caries or mucosal lesions in the oral cavity or patients with severe periodontitis; 5. Uncontrolled systemic disease; 6. undergoing chemotherapy or having a history of malignant tumor; 7. Undergoing orthodontic treatment; 8. Pregnant or lactating women or have a childbearing plan in the past 3 months; 9. Participate in other clinical trials within three months before screening; 10. Subjects who are deemed unsuitable by the investigator to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Reduction rate of gingival inflammation;

Countries

China

Contacts

Public ContactLi Yanfen

Affiliated Stomatological Hospital of Nanjing University School of Medicine

liyanfen2003@126.com+86 18260042143

Outcome results

None listed

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