NCT07402694

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Periodontitis is a chronic inflammatory disease initiated by dental plaque biofilm as the primary etiological factor. Its main pathological feature is the progressive destruction of periodontal supporting tissues. Currently, mechanical removal of dental calculus and plaque remains the foundational treatment for periodontitis, primarily consisting of supragingival scaling, subgingival curettage, and root planing. However, such treatments have certain limitations: microorganisms from other areas in the oral cavity can recolonize the periodontal pockets, leading to disease recurrence. Therefore, the adjuvant use of antimicrobial agents is often necessary. Nevertheless, long-term or extensive use of antibiotics can easily induce bacterial resistance, resulting in the gradual evolution of various pathogenic bacteria associated with human diseases into multidrug-resistant strains. Amphion oral rinse is a mouthwash developed based on cell membrane-mimicking polymer materials, with its core breakthrough being its "zero immunogenicity" property. By forming a long-lasting physical barrier on the oral surface, this product effectively inhibits plaque regrowth and avoids side effects such as flora imbalance caused by broad-spectrum antimicrobial activity. The duration of its barrier effect can exceed 7 days. Consequently, in the treatment of periodontal diseases, Amphion oral rinse demonstrates potential advantages over traditional antibiotic-based medications. It is expected to serve as an effective means of plaque control, complementing mechanical therapies and other approaches to eliminate periodontal pathogenic microorganisms, reduce or eliminate local inflammatory responses, and thereby achieve the goal of adjuvant treatment for periodontitis.

Conditions

• Periodontitis
• Mouthwash

Interventions

Type	Name	Description
DRUG	Amphion® Mouthwash	All enrolled subjects first receive non-surgical periodontal treatments (scaling, root planing, debridement). Upon completion, they immediately undergo periodontal irrigation with Amphion® Mouthwash according to their group assignment and receive standardized oral hygiene instructions. Subsequently, subjects begin the home rinsing regimen: twice daily (morning and evening), using 15 mL of Amphion® Mouthwash for 1 minute per rinse before expectorating.
DRUG	Placebo Mouthwash	All enrolled subjects first receive non-surgical periodontal treatments (scaling, root planing, debridement). Upon completion, they immediately undergo periodontal irrigation with Placebo Mouthwash according to their group assignment and receive standardized oral hygiene instructions. Subsequently, subjects begin the home rinsing regimen: twice daily (morning and evening), using 15 mL of Placebo Mouthwash for 1 minute per rinse before expectorating.

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2026-02-11
• Last updated: 2026-02-11

Locations

1 site across 1 country: China