This retrospective cohort study included 300 chronic periodontitis patients (mean age 52.3 ± 8.7 years; 56% male) with partial edentulism who underwent implant rehabilitation with adjunctive Kangfuxin solution for a minimum of 6 weeks. The comparator was a historical benchmark of 12% peri-implantitis incidence.
At 6 months, probing depth decreased from 4.8 ± 0.6 mm to 3.4 ± 0.5 mm (p < 0.001), and clinical attachment level improved from 5.1 ± 0.8 mm to 4.0 ± 0.7 mm (p < 0.001). Peri-implantitis incidence was 3.0% versus the 12% historical benchmark (p = 0.001). Marginal bone loss was 0.28 ± 0.12 mm. Bite force improved by 39.6% (p < 0.001), and mixing ability index increased from 48.3 ± 9.2 to 61.4 ± 7.8 (p < 0.001). Inflammatory biomarkers (IL-1β, IL-6, TNF-α) decreased significantly (all p < 0.001) in a subset of 80 patients. Implant survival was 99.6%.
Safety: 1.3% of patients experienced mild mucosal irritation; no serious adverse events or discontinuations were reported. Subgroup analysis suggested superior PD reduction in patients with severe periodontitis and Kangfuxin exposure ≥9 weeks.
Key limitations include the retrospective cohort design, use of a historical benchmark rather than a concurrent control, and the need for randomized trials to confirm these findings. Causality cannot be established from this observational study.
Practice relevance: Adjunctive Kangfuxin solution may improve peri-implant parameters and masticatory function at 6 months with favorable safety, but clinicians should interpret these results cautiously given the study design.
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BackgroundChronic periodontitis increases peri-implant disease risk and compromises masticatory function. Kangfuxin solution, a traditional Chinese medicine with anti-inflammatory properties, has shown efficacy in periodontal therapy but remains unevaluated in peri-implant disease prevention. This study assessed its 6-month effects on peri-implant health and masticatory function.MethodsThis retrospective cohort included 300 chronic periodontitis patients (mean age 52.3 ± 8.7 years; 56% male) with partial edentulism who received implant rehabilitation with adjunctive Kangfuxin solution for a minimum of 6 weeks between January 2019 and June 2024. Primary outcomes were changes in probing depth (PD) and clinical attachment level (CAL). Secondary outcomes included peri-implantitis incidence, marginal bone loss (MBL), bite force, mixing ability index (MAI), and inflammatory biomarkers (n = 80).ResultsAt 6 months, mean PD decreased from 4.8 ± 0.6 mm to 3.4 ± 0.5 mm (p < 0.001) and CAL from 5.1 ± 0.8 mm to 4.0 ± 0.7 mm (p < 0.001). Peri-implantitis incidence was 3.0% (vs. 12% historical benchmark, p = 0.001). MBL averaged 0.28 ± 0.12 mm (94.7% < 0.5 mm). Bite force improved by 39.6% (p < 0.001) and MAI from 48.3 ± 9.2 to 61.4 ± 7.8 (p < 0.001). IL-1β, IL-6, and TNF-α decreased significantly (all p < 0.001). Severe periodontitis and prolonged Kangfuxin exposure (≥9 weeks) showed superior PD reduction. Adverse events were minimal (1.3% mild mucosal irritation); implant survival was 99.6%.ConclusionsAdjunctive Kangfuxin solution significantly improved peri-implant parameters and masticatory function at 6 months with favorable safety. Randomized trials are warranted to establish its role in high-risk implant patients.