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Journal of Peking University (Health Sciences) ›› 2025, Vol. 57 ›› Issue (1): 91-96. doi: 10.19723/j.issn.1671-167X.2025.01.014

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Microneedle combined with photodynamic therapy in the treatment of oral leukoplakia

Ying HAN, Pu ZHAO, Hongwei LIU*()   

  1. Department of Oral Medicine, Peking University School and Hospital of Stomatology & National Center for Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Research Center of Oral Biomaterials and Digital Medical Devices & NMPA Key Laboratory for Dental Materials, Beijing 100081, China
  • Received:2024-09-30 Online:2025-02-18 Published:2025-01-25
  • Contact: Hongwei LIU E-mail:hongweil@126.com
  • Supported by:
    Clinical Research Foundation of Peking University School and Hospital of Stomatology(PKUSS-2023CRF304);Program for New Clinical Techniques and Therapies of Peking University School and Hospital of Stomatology(PKUSSNCT-21A13)

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Abstract:

Objective: To explore whether microneedle pretreatment can significantly improve the efficacy and safety of 5-aminolevulinic acid (ALA)-photodynamic therapy (PDT) in the treatment of oral leukoplakia. Methods: A non-randomized controlled clinical trial was conducted. Patients with clinical and pathological diagnosis of oral leukoplakia in the Department of Oral Mucosa, Peking University School and Hospital of Stomatology were divided into experimental group and control group. The control group was treated with conventional ALA-PDT, and the experimental group was pretreated with micro- needle buckling under superficial anesthesia with lidocaine before conventional ALA-PDT. The clinical manifestations of the two groups were recorded, the lesion area was measured, the clinical efficacy was evaluated, the number of treatment sessions and treatment unit duration were analyzed, and the pain after treatment was evaluated by visual analogue scale. The above data of the two groups were statistically analyzed. Results: A total of 11 patients were included in the experimental group and 19 patients were included in the control group. The complete remission rate of the experimental group and the control group was 45.5% and 36.8%, the partial remission rate was 54.5% and 57.9%, and the no remission rate was 0% and 5%, respectively. There was no significant difference in the treatment effect between the two groups. Meanwhile, the treatment unit duration of the experimental group and the control group were (9.05±5.74) min/cm2 and (21.38±15.44) min/cm2, respectively, and the number of treatment sessions were (2.36±0.67) times and (3.58±1.57) times, respectively. These differences between the two groups were statistically significant (t=-3.125, P < 0.05; t=-2.932, P < 0.05). Similarly, multiple linear regression analysis with 7 factors including age, dysplastic pathology, lesion classification, etc., also confirmed that pretreatment could significantly shorten the treatment unit duration (P < 0.05). In addition, there was no significant difference in pain score (visual analogue scale) between the two groups after treatment, and the microneedle puncture pretreatment did not increase the adverse reactions of ALA-PDT treatment. Conclusion: Microneedle pretreatment followed by conventional ALA-PDT shows a good clinical effect on oral leukoplakia, which can significantly shorten the clinical treatment time, reduce the number of visits, and save medical costs.

Key words: Oral leukoplakia, Photodynamic therapy, Microneedle pretreatment

CLC Number: 

  • R781.5

Figure 1

Laser therapy was applied  Figure 2  Pretreatment before applying ALA (A, the dental probe was used to buckle the lesion area; B, after buckling the lesion with local redness) ALA, 5-aminolevulinic acid."

Table 1

Demographic data, lesion classification and dysplastic pathology of the oral leukoplakia patients in the experimental and the control group"

ItemsExperimental group (n=11)Control group (n=19)
Age/years, ${\bar x}$±s57.36±15.3756.37±12.20
Sex, n(%)
  Male10 (90.9)7 (36.8)
  Female1 (9.1)12 (63.2)
Oral leukoplakia history/month, ${\bar x}$±s42.47±52.583±22.10
Smoke history, n(%)
  Yes3 (27.3)2 (10.5)
  No8 (72.7)17 (89.5)
Total lesion area/cm2, ${\bar x}$±s5.21±4.602.65±2.35
Lesions location, n(%)
  Keratinized1 (9.1)44(21.1)
  Non-keratinized10 (90.9)15(78.9)
Lesion classification, n(%)
  Non-homogenous6 (54.5)15 (78.9)
  Homogenous5 (45.5)4 (21.1)
Dysplastic pathology, n(%)
  Non-dysplastic3 (27.3)4 (21.1)
  Mildly dysplastic2 (18.2)5 (26.3)
  Moderately to severely dysplastic6 (54.5)10 (52.6)

Table 2

Clinical outcomes of ALA-PDT in the experimental and the control group"

ItemExperimental group (n=11)Control group (n=19)StatisticsP
Response to ALA-PDT, n(%)Z=-1.0310.456
  Complete remission and partial remission11 (100)18 (95)
  No remission01 (5)
Treatment unit duration (min/cm2), ${\bar x}$±s9.06±5.7421.38±15.44t=-3.125< 0.05
Number of treatment sessions, ${\bar x}$±s2.36±0.673.58±1.57t=-2.932< 0.05

Figure 3

The changes of lesion before and after treatment in the oral leukoplakia patients of the experimental group A1, A2, oral leukoplakia with mildly dysplastic on the left tongue and abdomen was partial remission after treatment; B1, B2, oral leukoplakia with moderately dysplastic on the left buccal mucosa was complete remission after treatment; C1, C2, oral leukoplakia with moderately to severely dysplastic on the left tongue mucosa was complete remission after treatment."

Table 3

Treatment unit duration in different dysplastic pathology of the oral leukoplakia"

Dysplastic pathologyTreatment unit duration/(min/cm2)
Experimental group (n=11)Control group (n=19)
Non-dysplastic4.68±2.8922.51±18.55
Mildly dysplastic6.37±4.3815.05±4.93
Moderately to severely dysplastic12.14±5.7324.09±16.65

Table 4

Multiple linear regression analysis of the treatment unit duration of ALA-PDT in oral leukoplakia"

Independent variablesBSEβtP
Constant4.91426.5620.1850.855
Age-0.0250.206-0.024-0.1220.904
Oral leukoplakia history0.0020.0590.0070.0330.974
Pretreatment13.0995.9430.0462.2040.038
Smoking55.2397.453-0.142-0.7030.489
Dysplastic pathology2.8023.5830.1680.7820.443
Lesions location-4.5777.683-0.124-0.5960.557
lesion classification2.6656.1840.0890.4310.671
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