Oral and maxillofacial venous malformations are common congenital vascular disorders in children that seriously impair their physical and mental health. Sclerotherapy is currently the preferred treatment, yet clinical practice has shown that bleomycin alone may not be effective in some cases. This study aims to compare the clinical efficacy and safety of 1% polidocanol foam combined with bleomycin versus bleomycin monotherapy for sclerotherapy of oral and maxillofacial venous malformations in children under the guidance of digital subtraction angiography (DSA), aiming to explore the clinical value of the combination regimen.

A prospective cohort study design was adopted. A total of 38 children with oral and maxillofacial venous malformations undergoing polidocanol foam combined with bleomycin sclerotherapy in our department from May 2024 to December 2025 were consecutively enrolled and served as the observation group. Another 38 children who received bleomycin sclerotherapy alone at our hospital during the same period were selected as the control group. All patients were regularly followed up for 4 to 12 months. Clinical baseline data, treatment response rate, lesion area, number of treatment sessions, cosmetic satisfaction, recurrence rate, and adverse events were observed and compared between groups. Binary logistic regression analysis was used to analyze clinical factors influencing the efficacy for oral and maxillofacial venous malformations in children.

① No statistically significant differences were observed between the 2 groups in terms of age, sex, lesion location, or Puig classification. ② The overall treatment response rate was significantly higher in the observation group than in the control group (94.74% vs 78.95%, P=0.042), yet no significant difference was found in the distribution of treatment efficacy grades (Z=1.949, P=0.051). There was no significant difference in pre-treatment lesion area between the 2 groups (P=0.725). After treatment, the area was notably reduced in both groups compared with their corresponding baseline values (P< 0.001). The observation group had a smaller lesion area than the control group at the corresponding post-treatment time point [(1.48±0.42) cm² vs (2.32±0.61) cm², P<0.001], and the rate of lesion area reduction was also markedly higher in the observation group [(51.24±10.47)% vs (37.82±5.43)%, P<0.001]. Additionally, the number of treatment sessions required in the observation group was notably lower than that in the control group (2.05±0.26 vs 2.90±0.21, P<0.001). ③ Compared with the control group, the observation group showed no statistical difference in overall aesthetic satisfaction [38 (100.00%) vs 34(89.47%), P=0.115], yet, the distribution of satisfaction grades was superior (Z=2.394, P=0.017). While, no statistically significant difference was observed in the recurrence rate between the 2 groups [1 (2.78%) vs 4(13.33%), P=0.109]. ④ There existed no statistical differences in individual adverse events or total events between the observation group and the control group [5 cases (13.16%) vs 3 cases (7.89%), P= 0.711]. ⑤ Binary logistic regression analysis revealed that combination therapy was an independent protective factor for overall treatment efficacy (OR=5.13, 95%CI: 3.08 to 8.62, P=0.014).

Compared with bleomycin sclerotherapy alone, the application of polidocanol foam combined with bleomycin sclerotherapy for oral and maxillofacial venous malformations in children can significantly improve treatment response rate, reduce lesion area, and decrease the number of treatment sessions, without increasing the risk of complications.