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

NCT07402694 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 2025-2053
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Periodontitis; Mouthwash

Outcome Measures

Primary Outcomes (1)

• Mean full-mouth Plaque Index (PI)

  The PI assesses the thickness of plaque at the gingival margin. Four sites per tooth (mesial, distal, buccal, lingual) are scored from 0 (no plaque) to 3 (abundance of plaque). A lower score indicates better oral hygiene. The outcome will be reported as the mean PI score per patient across all examined sites.

  Before treatment (baseline), and at 6 weeks and 3 months after treatment.

Secondary Outcomes (18)

• Mean full-mouth Bleeding Index (BI)

  Pre-treatment (baseline), 6 weeks post-treatment, and 3 months post-treatment

• Mean Pocket Probing Depth (PPD)

  Pre-treatment (baseline), 6 weeks post-treatment, and 3 months post-treatment

• Mean Clinical Attachment Level (CAL)

  Pre-treatment (baseline), 6 weeks post-treatment, and 3 months post-treatment

• Microbial composition of subgingival plaque (relative abundance of key periodontal pathogens)

  Pre-treatment (baseline), 6 weeks post-treatment, and 3 months post-treatment

• Microbial composition of salivary plaque (total bacterial load and diversity)

  Baseline (pre-treatment), 6 weeks, and 3 months post-treatment

Study Arms (2)

Amphion® Mouthwash Group

EXPERIMENTAL

Receives non-surgical periodontal therapy followed by irrigation and daily rinsing with Amphion® Mouthwash containing the active ingredient.

Drug: Amphion® Mouthwash

Placebo Mouthwash Group

PLACEBO COMPARATOR

Receives non-surgical periodontal therapy followed by irrigation and daily rinsing with a placebo mouthwash identical in appearance, odor, and taste but containing no active ingredient.

Drug: Placebo Mouthwash

Interventions

Amphion® Mouthwash DRUG

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.

Amphion® Mouthwash Group

Placebo Mouthwash DRUG

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.

Placebo Mouthwash Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

Location

Related Publications (9)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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.

  PMID: 27680288 RESULT

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Lihong Lei

CONTACT

00-86-571-86726890; kqllh@zju.edu.cn

Jiaqi Bao

CONTACT

00-86-571-87785085; baojiaqi@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2026
• First Posted: February 11, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 11, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)