Aplicação Subgengival de Eritritol e Clorexidina como Monoterapia na Terapia Periodontal Não Cirúrgica: Ensaio Clínico Randomizado

Resumo (EN)

This study evaluated the effect of subgingival erythritol + 0.3% chlorhexidine powder application as monotherapy during step II of periodontal treatment compared to conventional ultrasonic instrumentation followed by rubber cup and prophylactic paste polishing. The study was conducted at Universidade Paulista (UNIP), approved by the Research Ethics Committee (CEP/UNIP, CAAE 6332106, Opinion #6.332.106), and strictly followed CONSORT 2025 guidelines for randomized clinical trials.
This randomized, controlled, single-blind, split-mouth clinical trial included 28 patients (aged 30-80 years), both sexes, systemically healthy, diagnosed with stage II, III, or IV grade B or C periodontitis (Caton et al., 2018), presenting at least four uniradicular sites with probing depth ≥4 mm and bleeding on probing, distributed across two distinct hemiarches.
Initial screening, detailed anamnesis, oral hygiene instruction, plaque retentive factor removal, cavity sealing, supragingival scaling, and coronal polishing were performed. After 30 days, patients were re-evaluated to confirm inclusion criteria. Quadrants were randomized using computer-generated lists to receive: Test treatment — subgingival air-polishing with erythritol + 0.3% chlorhexidine powder; or Control treatment — ultrasonic instrumentation. Procedures were performed without initial local anesthesia, with patient-requested option available.
Sample size calculation was based on Sallum et al. (2005), considering clinical attachment level changes (95% power, α=0.05), predicting 19 patients, increased by 50% for potential losses, totaling 28 individuals. Clinical evaluations — probing depth (PD), gingival margin position (GMP), clinical attachment level (CAL), plaque presence at site (PP), bleeding on probing at site (BoP), full-mouth plaque index (FMPI), and full-mouth bleeding on probing index (FMBOP) — were conducted at baseline (T0), 3, and 6 months by a blinded calibrated examiner (intraclass correlation coefficient ≥0.90). Pain was assessed using the visual analog scale (VAS) immediately and 24 hours post-treatment. Monthly supragingival plaque control was performed. Statistical analysis used generalized linear mixed-effects models for repeated measures and McNemar test for dichotomous indices (SPSS, α=0.05).
Results showed significant PD reductions at 3 and 6 months in both groups (Control: 5.60±1.04 mm → 4.27±1.43 mm → 4.00±1.24 mm; Test: 5.46±1.10 mm → 4.64±1.43 mm → 4.78±1.80 mm). Site-specific bleeding on probing improved significantly at 6 months versus T0 (Control: 100% → 61%; Test: 100% → 78%). CAL reduced in Control at 3 and 6 months versus baseline (6.08±1.57 mm → 4.56±1.97 mm → 4.50±2.01 mm) but remained stable in Test (5.86±1.87 mm → 5.04±1.77 mm → 5.33±2.05 mm); intergroup difference at 6 months favored Control (4.50±2.01 mm vs. 5.33±2.05 mm from baseline) (P<0.05). GMP remained stable. VAS scores showed no statistical difference between treatments (Test: 41.5±28.25 mm, Control: 53.0±30.38 mm baseline). Anesthesia was required in 6 Control vs. 2 Test patients (P=0.125). Twenty-eight patients were treated; 25 completed 3 months; 18 completed 6 months.
In conclusion, isolated subgingival air-polishing with erythritol + 0.3% CHX effectively reduces probing depth and bleeding on probing during the active phase similarly to conventional treatment but is inferior to ultrasonic instrumentation for clinical attachment level gains at 6 months. Patient-centered outcomes showed no statistical differences.