Clinical oral implants research · 2025
Clinical and Radiographic Performance of Two Distinct Sandblasted, Large-Grit, Acid-Etched Implant Surfaces: A Split-Mouth Randomized Clinical Trial.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Vílchez Blanca, Caneiro Leticia, Lima Cristina, Sanz-Sánchez Ignacio, Montero Eduardo, Figuero Elena, Blanco Juan, Sanz Mariano
Аннотация
AIM: To compare the clinical performance of two sandblasted, large-grit, acid-etched implant surfaces regarding changes in radiographic marginal bone level (MBL) 12 months after loading.
MATERIALS AND METHODS: In this randomized, split-mouth, dual-center clinical trial, each patient received one test (modified hydrophilic surface) implant and one control (conventional surface) implant. The primary endpoint was the change in MBL measured 12 months after loading. Secondary outcomes included the assessment of soft tissue wound healing index (WHI), adverse events, implant stability quotient (ISQ), peri-implant soft tissue parameters (probing pocket depth, bleeding on probing, keratinized mucosa width), and oral health-related quality of life (OHRQoL) measured with the Oral Health Impact Profile-14 (OHIP-14). Generalized linear models, paired Student's t-tests, and Wilcoxon tests were employed for data analysis.
RESULTS: The study included 68 subjects (136 implants). No statistically significant differences were found between groups for any of the clinical outcomes measured. The mean change in MBL from loading to 12 months was 0.04 mm (SD = 0.39) for the modified hydrophilic implants and 0.07 mm (SD = 0.22) for the conventional implants (p = 0.658), with no significant differences between the groups.
CONCLUSIONS: Over a 12-month period of functional loading, both implant surfaces demonstrated comparable performance regarding peri-implant bone stability, safety, and clinical outcomes. Although a small but statistically significant difference between groups was observed in MBL changes from baseline to 12 months (MD = 0.15 mm), no significant differences were found in MBL changes from loading to 12 months (primary outcome), ISQ, soft tissue healing, or peri-implant health.
MATERIALS AND METHODS: In this randomized, split-mouth, dual-center clinical trial, each patient received one test (modified hydrophilic surface) implant and one control (conventional surface) implant. The primary endpoint was the change in MBL measured 12 months after loading. Secondary outcomes included the assessment of soft tissue wound healing index (WHI), adverse events, implant stability quotient (ISQ), peri-implant soft tissue parameters (probing pocket depth, bleeding on probing, keratinized mucosa width), and oral health-related quality of life (OHRQoL) measured with the Oral Health Impact Profile-14 (OHIP-14). Generalized linear models, paired Student's t-tests, and Wilcoxon tests were employed for data analysis.
RESULTS: The study included 68 subjects (136 implants). No statistically significant differences were found between groups for any of the clinical outcomes measured. The mean change in MBL from loading to 12 months was 0.04 mm (SD = 0.39) for the modified hydrophilic implants and 0.07 mm (SD = 0.22) for the conventional implants (p = 0.658), with no significant differences between the groups.
CONCLUSIONS: Over a 12-month period of functional loading, both implant surfaces demonstrated comparable performance regarding peri-implant bone stability, safety, and clinical outcomes. Although a small but statistically significant difference between groups was observed in MBL changes from baseline to 12 months (MD = 0.15 mm), no significant differences were found in MBL changes from loading to 12 months (primary outcome), ISQ, soft tissue healing, or peri-implant health.