Oral Health Outcomes With Amphion Mouthwash as an Adjunct to Non-Surgical Periodontal Therapy

Starting soon · Phase 4 · Has a placebo group

Conditions studied: Periodontitis, Mouthwash

In brief

Periodontitis is a chronic inflammation caused by dental plaque that can destroy periodontal tissues. Current primary treatments include mechanical removal methods such as supragingival scaling and subgingival curettage. However, issues like microbial recolonization leading to inflammation recurrence exist, often necessitating the use of antimicrobial agents. Prolonged antibiotic use, however, can easily lead to bacterial resistance. Amphion oral rinse is a novel biomimetic material mouthwash. It inhibits plaque regrowth by forming a long-lasting physical barrier and avoids flora imbalance. Compared with traditional antibiotics, this product has shown unique advantages in the adjuvant treatment of periodontal diseases. This study aims to evaluate the efficacy of Amphion rinse combined with conventional periodontal therapy in patients with stage I-IV periodontitis, including plaque control and inflammation improvement. Additionally, it will analyze its impact on the oral microbiome and collect user experience feedback to provide a reference for its clinical application.

Key facts

Study ID

NCT07402694

Run by

Second Affiliated Hospital, Zhejiang University, School of Medicine

People needed

60

Starts

2026-03-01

Expected to finish

2027-12-31

Last updated by the study team

2026-02-11

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged between 18 and 65 years old.
• At least 20 natural teeth (excluding root remnants) present in the oral cavity.
• Diagnosed with Stage I-IV periodontitis according to the 2018 new classification of periodontal diseases.
• No impairment in vision, motor function, or cognitive ability, capable of understanding and cooperating with the study.
• Not undergoing any orthodontic treatment and not wearing removable partial dentures during the study period.
• Fully informed and voluntarily signed a written informed consent form.

You may not qualify if…

• Individuals allergic to any component used in the study.
• Pregnant or lactating women.
• Those who have undergone periodontal treatments such as scaling, root planing, or used antimicrobial mouthwash within the past 3 months.
• Those with a history of systemic hormone or antibiotic use within the past 3 months, or who are assessed as requiring adjunctive use of such medications during periodontal treatment.
• Individuals with underlying systemic diseases that may affect the evaluation of periodontal status, including but not limited to: abnormal liver function, renal insufficiency, hematological diseases, neurological or psychiatric disorders, systemic bone diseases, diabetes, coronary heart disease, malignant tumors, etc.
• Current or former smokers (including active or passive smoking), or users of other nicotine and tobacco products (such as e-cigarettes, chewing tobacco).

Where it is running

• The Second Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou, Zhejiang, China

Full record on ClinicalTrials.gov

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