Oral Health Outcomes With Amphion Mouthwash as an Adjunct to Non-Surgical Periodontal Therapy
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.
Timeline
- Start
- 2026-03-01
- Primary completion
- 2027-12-31
- Completion
- 2027-12-31
Publications
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results Teng F, He T, Huang S, Bo CP, Li Z, Chang JL, Liu JQ, Charbonneau D, Xu J, Li R, Ling JQ. Cetylpyridinium chloride mouth rinses alleviate experimental gingivitis by inhibiting dental plaque maturation. Int J Oral Sci. 2016 Sep 29;8(3):182-90. doi: 10.1038/ijos.2016.18.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amphion | Unknown | 15 ml | Oral |