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This study is a single-center, split-mouth controlled, randomized controlled trial, reported in accordance with the CONSORT (Consolidated Standards of Reporting Trials) guidelines. The study was approved by the Medical Ethics Committee of Dongyang People's Hospital (Approval No.: 2024-YX-081) and registered on the Chinese Clinical Trial Registry (ChiCTR) number: ChiCTR2600124289. All participants provided written informed consent prior to enrollment. The study was conducted in compliance with the principles of the Declaration of Helsinki. We conducted a clinical study to evaluate and compare the effectiveness of NMFT-assisted SRP and conventional SRP. A total of 20 participants were enrolled in the study from December 2023 to November 2024.
Sample size estimation
Based on preliminary pilot data, the expected difference in probing depth (PD) reduction at 6 weeks between NMFT-assisted SRP and conventional SRP was 0.5 mm, with a pooled standard deviation of 0.8 mm. The significance level (α) was set at 0.05 (two-sided), and the test power (1-β) was set at 0.80. Using the sample size calculation formula for paired designs, the minimum required sample size was determined to be 16 patients. To account for an estimated dropout rate of approximately 20%, the study ultimately planned to include 20 patients.
Selection criteria
Inclusion criteria:(1) Patients with a diagnosis of generalized periodontitis, categorized as Stage II or III according to the 2017 world workshop on the classification of periodontal and peri-implant diseases and conditions, a widely accepted framework for periodontitis staging and grading15 requiring SRP following oral hygiene instruction and supragingival scaling; (2) A minimum of 20 natural teeth present in the oral cavity; (3) Systemically healthy with no significant medical conditions; Exclusion criteria: (1) Presence of defective dental restorations that could interfere with the examination; (2) Periodontal therapy performed within the past year; (3) Antibiotic use within the last 3 months; (4) Pregnant or lactating women; (5) Systemic diseases that could affect treatment outcomes (e.g., uncontrolled diabetes and immunocompromised conditions); (6) Unwillingness to participate in the study.
Randomization and allocation concealment
All patients were assigned sequential numbers (001–020). The treatment side (test/control) for each patient was determined using a random number table. The randomization rule was as follows: if the random number was odd, the left side was assigned to the experimental group (NMFT), and if the random number was even, the right side was assigned to the experimental group. Treatment was administered in two sessions, with the order of treatment initiation for either side determined by the patient. The complete raw dataset supporting the findings of this study is available in Supplementary File 1.
Interventions
Overview
All SRP treatments were completed in two sessions by the same board-certified periodontist with extensive clinical experience. Before each treatment session, patients received local anesthesia via appropriate infiltration injections of 4% articaine with 1:100,000 epinephrine. All patients included in this study were in the active phase of chronic periodontitis, with generalized inflammatory and friable gingiva, which facilitated the implementation of NMFT. At sites with thicker, fibrotic gingiva, the visibility of NMFT may be limited, and traditional SRP is still relied upon in such cases. During the procedure, continuous suction was used to control bleeding and ensure a clear field of vision.
NMFT-aided SRP
A subgingival ultrasonic scaler tip was used in low-power mode (power setting: 50–60% output power) to gently separate the gingival tissue. Enhanced visualization of subgingival calculus was achieved through the following steps: (1) An assistant used a high-suction evacuator for continuous suction of gingival crevicular fluid and blood to maintain a clear operative field (Figure 1). (2) A high-definition intraoral mirror was used to reflect light, allowing direct observation of subgingival calculus. (3) Gracey curettes were used for root surface planing, with an average operation time of approximately 5–7 min per tooth site. The smoothness of the root surface was subsequently verified using an 11/12 explorer. Each patient received personalized post-treatment instructions: brushing teeth twice daily using the modified Bass technique (bristles at a 45° angle) and performing interdental cleaning once daily using personalized interdental cleaning tools (interdental brushes/dental floss, selected based on the size of the interdental space).
Conventional SRP
The conventional treatment group received standard SRP, which was performed using a subgingival ultrasonic scaler tip and a full set of Gracey curettes (5/6, 7/8, 11/12, and 13/14). The treating clinician systematically evaluated the root surfaces with an 11/12 explorer to ensure complete calculus removal and optimal smoothness. The average treatment time per quadrant was approximately 25 ± 5 min for the NMFT group and 20 ± 4 min for the conventional SRP group. Although NMFT was slightly more time-consuming, visual assistance may enhance debridement efficiency. Each patient in the conventional treatment group received the same personalized post-treatment instructions as those in the NMFT-assisted SRP group. All the equipment used in the study is shown in Supplementary file 2.
Data collection and evaluation
The examiners underwent standardized calibration training prior to the study, including theoretical instruction and hands-on practice with models. Calibration consistency was assessed by repeatedly measuring periodontal sites (120 sites in total) on 10 non-study patients. The results showed an intraclass correlation coefficient (ICC) of 0.92 for PD measurements, 0.89 for clinical attachment loss (CAL), and a Kappa value of 0.85 for bleeding on probing (BOP), indicating good consistency and reliability among the examiners. At baseline, all participants underwent standardized periodontal examinations by a calibrated examiner blinded to group assignments. Using a UNC-15 periodontal probe, the examiner recorded PD, CAL, and BOP. The same blinded examiner conducted all follow-up assessments at approximately 6 weeks and 3 months post-SRP, following the same measurement protocol as at baseline. The primary outcome measures were changes in clinical periodontal parameters (PD, CAL, and BOP) after SRP.
Data analysis
Statistical analysis was performed using IBM SPSS Statistics software (version 26.0). Given the split-mouth design of this study, in which both sides of the same patient's mouth received NMFT-assisted SRP and conventional SRP, respectively, all comparisons of primary efficacy outcomes were conducted using paired-samples t-tests. Specifically, for continuous variables (e.g., reductions in PD, gains in CAL), paired-samples t-tests were used to compare the NMFT-treated side with the control side within each patient. For dichotomous variables (e.g., BOP-positive rate), paired-sample McNemar tests were used. The significance threshold was set at α = 0.05 (two-tailed), with P-values < 0.05 considered statistically significant. For patients who dropped out of the study, the intention-to-treat (ITT) principle was applied, with the last observation carried forward (LOCF) method used for primary outcome analysis. Sensitivity analysis was conducted using the complete dataset, and the results were consistent with the ITT analysis.