Clinical evaluation of cold plasma surface activation using different plasma systems on early implant stability: a randomized controlled within-patient trial
摘要
Early implant stability is a relevant surrogate during the transition from mechanical primary stability to biologically mediated secondary stability. Cold plasma activation may improve titanium surface readiness, but direct clinical comparisons remain limited.
MethodsThis prospective, single-center, randomized, within-patient controlled trial compared untreated control implants with three pre-insertion plasma protocols: vacuum plasma, argon jet plasma, and cold atmospheric plasma. Eleven patients received 44 implants. One patient/four implants was excluded for insufficient primary stability. The final analysis included 40 implants in 10 patients, each contributing one implant per group. Implant sites were not anatomically mirrored. Plasma was applied for 60 s before placement. Implant stability quotient (ISQ) was recorded at baseline and at 14, 28, and 56 days. A nested linear mixed-effects model was used for statistical inference.
ResultsAll analyzed implants remained in situ throughout follow-up, and no adverse events were recorded. Baseline ISQ values were comparable across groups (70.6–70.9), without establishing anatomical equivalence. Control implants showed a transient ISQ decrease at day 28, whereas plasma-treated implants showed increasing ISQ values. The group-by-time interaction was significant (likelihood-ratio chi-square(9) = 188.73, p < 0.001). At day 56, model-based mean differences versus control were + 10.0 ISQ units for vacuum plasma, + 8.9 for argon jet plasma, and + 8.3 for cold atmospheric plasma (all p < 0.001). Sensitivity analyses preserved the association direction.
ConclusionsCold plasma activation was associated with a more favorable early ISQ trajectory than untreated implants during the first 8 weeks. Given the small, retrospectively registered, site-heterogeneous, ISQ-based design, larger prospectively registered, site-standardized trials are warranted.
Trial registrationRetrospectively registered at ClinicalTrials.gov, NCT07348770. First submitted: 11 December 2025; first posted: 16 January 2026; latest update posted: 11 May 2026.