PeriodontitisPhase 4NCT07402694
Oral Health Outcomes With Amphion Mouthwash as an Adjunct to Non-Surgical Periodontal Therapy
A Phase 4 study testing Amphion® Mouthwash in people with Periodontitis and Mouthwash, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Periodontitis, Mouthwash
- What is being tested?
- Amphion® Mouthwash
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2026to 31 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Human Subject Research Ethics Commitee, 00-86-571-87783759, keyanlunli_zheer@163.com
About this study
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.
Read the 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
- Being tested
- Amphion® Mouthwash, Placebo Mouthwash
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amphion® MouthwashDrug
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.
Placebo MouthwashDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Amphion® Mouthwash Group | Experimental | Receives non-surgical periodontal therapy followed by irrigation and daily rinsing with Amphion® Mouthwash containing the active ingredient. Receives: 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. Receives: Drug: Placebo Mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before treatment (baseline), and at 6 weeks and 3 months after treatment.
Secondary outcomes (18)
Mean full-mouth Bleeding Index (BI)
The BI assesses gingival inflammation by recording bleeding upon gentle probing. Each tooth is probed at four sites (mesial, distal, buccal, lingual) and scored as 0 (no bleeding within 30 seconds) or 1 (bleeding present). A lower score indicates healthier gingiva. The outcome will be reported as the mean BI score per patient (percentage of bleeding sites).
Measured: Pre-treatment (baseline), 6 weeks post-treatment, and 3 months post-treatment
Mean Pocket Probing Depth (PPD)
PPD is measured from the gingival margin to the base of the pocket using a periodontal probe. Measurements will be taken at six sites per tooth (mesiobuccal, mid-buccal, distobuccal, mesiolingual, mid-lingual, distolingual). The outcome will be reported as the mean PPD in millimeters per patient for all measured sites.
Measured: Pre-treatment (baseline), 6 weeks post-treatment, and 3 months post-treatment
Mean Clinical Attachment Level (CAL)
CAL is the distance from the Cemento-Enamel Junction (CEJ) to the base of the pocket, measured with a periodontal probe. It indicates the historical loss of periodontal support. Measurements at six sites per tooth. The outcome will be reported as the mean CAL in millimeters per patient for all measured sites.
Measured: Pre-treatment (baseline), 6 weeks post-treatment, and 3 months post-treatment
Microbial composition of subgingival plaque (relative abundance of key periodontal pathogens)
Subgingival plaque samples will be collected from pre-selected deep pockets. Microbial composition (e.g., relative abundance of Porphyromonas gingivalis, Treponema denticola, Tannerella forsythia) will be analyzed via 16S rRNA gene sequencing or specific PCR. The outcome will be reported as the change in relative abundance (%) of target pathogens from baseline.
Measured: Pre-treatment (baseline), 6 weeks post-treatment, and 3 months post-treatment
Microbial composition of salivary plaque (total bacterial load and diversity)
Unstimulated whole saliva will be collected. Total bacterial load (by quantitative PCR) and microbial alpha-diversity (e.g., Shannon Index) will be assessed. The outcome will be reported as the change in total bacterial count (gene copies/mL) and Shannon Index value from baseline.
Measured: Baseline (pre-treatment), 6 weeks, and 3 months post-treatment
Root surface hypersensitivity assessed by a Visual Analogue Scale (VAS)
Participants rate their level of tooth sensitivity to cold air/water on a 100-mm horizontal VAS, where 0 mm = "No pain" and 100 mm = "Unbearable pain". A lower score indicates less sensitivity. The outcome will be reported as the mean VAS score (mm) per patient.
Measured: Pre-treatment (baseline), 6 weeks post-treatment, and 3 months post-treatment
Alteration in taste sensation assessed by a 5-point Likert scale
Participants report any change in taste sensation using a questionnaire with a Likert scale from 1 (Much Worse) to 5 (Much Better). A score of 3 indicates "No Change". The outcome will be reported as the frequency and percentage of patients in each response category.
Measured: 6 weeks and 3 months post-treatment (during rinsing period).
Patient adherence to rinsing regimen (days of rinsing completed)
Adherence is monitored via patient diary and bottle return/weighing. The outcome will be reported as the percentage of prescribed rinsing days completed (e.g., 90% adherence means the subject performed rinsing on 81 out of 90 expected days).
Measured: Through study completion, an average of 6 weeks
Periodontitis Staging and Grading
The specific stage (I, II, III, IV, reflecting disease severity and complexity) and grade (A, B, C, reflecting the rate of progression and risk assessment) of periodontitis will be recorded for each patient according to the 2018 new classification of periodontal diseases. This will serve as a key baseline variable for subgroup analysis.
Measured: Baseline.
Medication History
A systematic record of the patient's current long-term medication use, particularly drugs that may affect periodontal tissues or healing (e.g., calcium channel blockers, anticonvulsants, immunosuppressants, long-term NSAIDs, etc.). Categorized as "Yes" or "No".
Measured: Baseline
Oral Health-Related Quality of Life (OHRQoL)
Assessment using a validated short-form scale (e.g., Oral Health Impact Profile-14, OHIP-14). The scale contains 14 questions covering dimensions such as functional limitation, pain, and psychological discomfort. A higher total score indicates a greater negative impact of oral health on quality of life.
Measured: Baseline, 3 months post-treatment
Age
Age in years at the time of enrollment.
Measured: Baseline
Gender
Self-reported gender, categorized as Male or Female.
Measured: Baseline
Body Mass Index (BMI)
Body mass index calculated as weight in kilograms divided by height in meters squared (kg/m²). Categorized per Chinese Adult Guidelines: Underweight (<18.5 kg/m²), Normal (18.5-23.9 kg/m²), Overweight (24.0-27.9 kg/m²), Obese (≥28.0 kg/m²).
Measured: Baseline.
Tooth Brushing - Frequency
Self-reported frequency of daily tooth brushing. Categorized as: Once per day, Twice per day, More than twice per day, or Occasionally/Not every day.
Measured: Before treatment (baseline), and at 6 weeks and 3 months after treatment.
Tooth Brushing - Method
Self-reported primary tooth brushing technique (e.g., Horizontal scrub, Bass method, Vertical sweep, etc.).
Measured: Before treatment (baseline), and at 6 weeks and 3 months after treatment.
Tooth Brushing - Duration
Self-reported average time spent brushing per session, in seconds/minutes. Categorized (e.g., <1 minute, 1-2 minutes, >2 minutes).
Measured: Before treatment (baseline), and at 6 weeks and 3 months after treatment.
Use of Dental Floss/Interdental Cleaners
Self-reported use of interdental cleaning aids. Assessed by type (dental floss, interdental brush) and frequency (e.g., Daily, Several times per week, Occasionally, Never).
Measured: Before treatment (baseline), and at 6 weeks and 3 months after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07402694
- Sponsor's protocol ID
- 2025-2053
- Status last verified
- Dec 2025
- First submitted
- 11 Jan 2026
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34728444Nardi 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.
PubMed 32932898Shaheen 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.
PubMed 35907673Rath 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.
PubMed 38461488Sparabombe 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.
PubMed 31191341Matayoshi 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.
PubMed 38307981Waqar 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.
PubMed 38183081Ozmeric 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.
PubMed 39881161Teng 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.
PubMed 27680288
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Health Outcomes With Amphion Mouthwash as an Adjunct to Non-Surgical Periodontal Therapy
- ClinicalTrials.gov ID
- NCT07402694
- Acronym / sponsor ID
- 2025-2053
- Conditions
- Periodontitis, Mouthwash
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 11 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amphion® Mouthwash Group | Experimental | Drug: Amphion® MouthwashReceives non-surgical periodontal therapy followed by irrigation and daily rinsing with Amphion® Mouthwash containing the active ingredient. |
| Placebo Mouthwash Group | Placebo comparator | Drug: Placebo MouthwashReceives 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amphion® MouthwashAll 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 | Amphion® Mouthwash Group |
| Placebo MouthwashAll 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. | Drug | Placebo Mouthwash Group |
Primary outcome
Mean full-mouth Plaque Index (PI)
Time frame: Before treatment (baseline), and at 6 weeks and 3 months after treatment.
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.
18 secondary outcomes
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
Gender
Time frame: Baseline
Body Mass Index (BMI)
Time frame: Baseline.
Tooth Brushing - Frequency
Time frame: Before treatment (baseline), and at 6 weeks and 3 months after treatment.
Tooth Brushing - Method
Time frame: Before treatment (baseline), and at 6 weeks and 3 months after treatment.
Tooth Brushing - Duration
Time frame: Before treatment (baseline), and at 6 weeks and 3 months after treatment.
Use of Dental Floss/Interdental Cleaners
Time frame: Before treatment (baseline), and at 6 weeks and 3 months after treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Results publication: PubMed 34728444Liu 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 publication: PubMed 32932898Nardi 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 publication: PubMed 35907673Shaheen 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 publication: PubMed 38461488Rath 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 publication: PubMed 31191341Sparabombe 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 publication: PubMed 38307981Matayoshi 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 publication: PubMed 38183081Waqar 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 publication: PubMed 39881161Ozmeric 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 publication: PubMed 27680288Teng 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.
- Individual participant dataSharing planned: No
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Apical Periodontitis, Endodontic Retreatment
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Ozone Gel, Chlorohexidine Gel
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amphion® Mouthwash in people with Periodontitis and Mouthwash, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lihong Lei (00-86-571-86726890, kqllh@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean full-mouth Plaque Index (PI) (time frame: Before treatment (baseline), and at 6 weeks and 3 months after treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07402694, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.