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

Overview

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.

Interventions

• 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.

Primary outcome measures

• Mean full-mouth Plaque Index (PI) [Time frame: Before treatment (baseline), and at 6 weeks and 3 months after treatment.]

Secondary outcome measures (12)

• Mean full-mouth Bleeding Index (BI) [Time frame: Pre-treatment (baseline), 6 weeks post-treatment, and 3 months post-treatment]
• Mean Pocket Probing Depth (PPD) [Time frame: Pre-treatment (baseline), 6 weeks post-treatment, and 3 months post-treatment]
• Mean Clinical Attachment Level (CAL) [Time frame: Pre-treatment (baseline), 6 weeks post-treatment, and 3 months post-treatment]
• Microbial composition of subgingival plaque (relative abundance of key periodontal pathogens) [Time frame: Pre-treatment (baseline), 6 weeks post-treatment, and 3 months post-treatment]
• Microbial composition of salivary plaque (total bacterial load and diversity) [Time frame: Baseline (pre-treatment), 6 weeks, and 3 months post-treatment]
• Root surface hypersensitivity assessed by a Visual Analogue Scale (VAS) [Time frame: Pre-treatment (baseline), 6 weeks post-treatment, and 3 months post-treatment]
• Alteration in taste sensation assessed by a 5-point Likert scale [Time frame: 6 weeks and 3 months post-treatment (during rinsing period).]
• Patient adherence to rinsing regimen (days of rinsing completed) [Time frame: Through study completion, an average of 6 weeks]
• Periodontitis Staging and Grading [Time frame: Baseline.]
• Medication History [Time frame: Baseline]
• Oral Health-Related Quality of Life (OHRQoL) [Time frame: Baseline, 3 months post-treatment]
• Age [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

China · 1 center

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

Publications

• Liu J, Huang Y, Lou X, Liu B, Liu W, An N, Wu R, Ouyang X. Effect of Pudilan Keyanning antibacterial mouthwash on dental plaque and gingival inflammation in patients during periodontal maintenance phase: study protocol for double-blind, randomised clinical trial. BMJ Open. 2021 Nov 2;11(11):e048992. doi: 10.1136/bmjopen-2021-048992. PMID 34728444
• Nardi GM, Cesarano F, Papa G, Chiavistelli L, Ardan R, Jedlinski M, Mazur M, Grassi R, Grassi FR. Evaluation of Salivary Matrix Metalloproteinase (MMP-8) in Periodontal Patients Undergoing Non-Surgical Periodontal Therapy and Mouthwash Based on Ozonated Olive Oil: A Randomized Clinical Trial. Int J Environ Res Public Health. 2020 Sep 11;17(18):6619. doi: 10.3390/ijerph17186619. PMID 32932898
• Shaheen MY, Al-Zawawi AS, Divakar DD, Aldulaijan HA, Basudan AM. Role of Chlorhexidine and Herbal Oral Rinses in Managing Periodontitis. Int Dent J. 2023 Apr;73(2):235-242. doi: 10.1016/j.identj.2022.06.027. Epub 2022 Jul 28. PMID 35907673
• Rath A, Wong M, Li K, Wong A, Tan L, Tan K, Pannuti CM. Efficacy of adjunctive octenidine hydrochloride as compared to chlorhexidine and placebo as adjuncts to instrumentation in stage I-II periodontitis: A double-blinded randomized controlled trial. Int J Dent Hyg. 2024 Nov;22(4):802-813. doi: 10.1111/idh.12795. Epub 2024 Mar 10. PMID 38461488
• Sparabombe S, Monterubbianesi R, Tosco V, Orilisi G, Hosein A, Ferrante L, Putignano A, Orsini G. Efficacy of an All-Natural Polyherbal Mouthwash in Patients With Periodontitis: A Single-Blind Randomized Controlled Trial. Front Physiol. 2019 May 22;10:632. doi: 10.3389/fphys.2019.00632. eCollection 2019. PMID 31191341
• Matayoshi S, Tojo F, Suehiro Y, Okuda M, Takagi M, Ochiai M, Kadono M, Mikasa Y, Okawa R, Nomura R, Itoh Y, Itoh N, Nakano K. Effects of mouthwash on periodontal pathogens and glycemic control in patients with type 2 diabetes mellitus. Sci Rep. 2024 Feb 2;14(1):2777. doi: 10.1038/s41598-024-53213-x. PMID 38307981
• Waqar SM, Razi A, Qureshi SS, Saher F, Zaidi SJA, Kumar C. Comparative evaluation of propolis mouthwash with 0.2% chlorhexidine mouthwash as an adjunct to mechanical therapy in improving the periodontitis among perimenopausal women: a randomized controlled trial. BMC Oral Health. 2024 Jan 5;24(1):26. doi: 10.1186/s12903-023-03768-4. PMID 38183081
• Ozmeric N, Enver A, Isler SC, Gokmenoglu C, Topaloglu M, Selamet H, Altun G, Aykol Sayar S. Evaluating the effects of chlorhexidine and vitamin c mouthwash on oral health in non-surgical periodontal therapy: a randomized controlled clinical trial. Sci Rep. 2025 Jan 29;15(1):3703. doi: 10.1038/s41598-025-88100-6. PMID 39881161

Identifiers

NCT: NCT07402694 · 2025-2053

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗