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

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.

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).

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.

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.

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.

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.

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.

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.

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).

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.

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".

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.

Age in years at the time of enrollment.

Self-reported gender, categorized as Male or Female.

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).

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.

Self-reported primary tooth brushing technique (e.g., Horizontal scrub, Bass method, Vertical sweep, etc.).

Self-reported average time spent brushing per session, in seconds/minutes. Categorized (e.g., <1 minute, 1-2 minutes, >2 minutes).

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).