Photodynamic Therapy, Photobiomodulation and Acetonide Triamcinolone 0.1% in the Treatment of Oral Lichen Planus: A Randomized Clinical Trial
Abstract
:1. Introduction
2. Material and Methods
2.1. Study Population
2.2. Study Design
- -
- Group 1: Patients with OLP subjected to photodynamic therapy (Helbo® blue photosensitizer with low-power laser irradiation) applied once a week for 4 sessions, with orabase cream application three times a day at home.
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- Group 2: Patients with OLP subjected to low-power laser irradiation applied once a week for 4 sessions, with orabase cream application three times a day.
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- Group 3: Patients with OLP subjected to inactive laser application once a week for 4 sessions with triamcinolone acetonide orabase cream 0.1% applied three times a day.
2.3. Application of Laser Phototherapy
2.4. Study Variables
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- Visit 1 (day 1): Thongprasom + VAS + OHIP-14 + HAD + treatment according to group
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- Visits 2 (day 7), 3 (day 14), and 4 (day 21): VAS + laser + treatment according to group
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- Visit 5 (1 month after the last visit): follow-up period with Thongprasom + VAS + OHIP-14 + HAD
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- Visit 6 (3 months after the fourth visit): follow-up period with VAS + OHIP-14 + HAD
2.5. Statistical Analysis
3. Results
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Total | Treatment | Test | p-Value | |||
---|---|---|---|---|---|---|
1 | 2 | 3 | ||||
Age | 60.7 (9.7) | 63.5 (9.5) | 61.3 (11.1) | 57.2 (7.7) | F(2;56) = 2.16 | 0.125 |
Gender | χ2(2) = 4.10 | 0.128 | ||||
Male | 8 (13.6) | 1 (5.0) | 2 (10.0) | 5 (26.3) | ||
Female | 51 (86.4) | 19 (95.0) | 18 (90.0) | 14 (73.7) | ||
Smoking | χ2(4) = 8.52 | 0.074 | ||||
Yes | 6 (10.2) | 1 (5.0) | 1 (5.0) | 4 (21.1) | ||
Ex-smoker | 11 (18.6) | 7 (35.0) | 2 (10.0) | 2 (10.5) | ||
Non-smoker | 41 (71.2) | 12 (60.0) | 17 (85.0) | 13 (68.4) | ||
Alcohol | χ2(6) = 10.49 | 0.106 | ||||
No | 37 (62.7) | 14 (70.0) | 15 (75.0) | 8 (42.1) | ||
1 glass/w | 14 (23.7) | 5 (25.0) | 4 (20.0) | 5 (26.3) | ||
2–3 glasses/w | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | ||
Social drinker | 8 (13.6) | 1 (5.0) | 1 (5.0) | 6 (31.6) | ||
Duration of OLP (years) | 4 (3.4) | 4.8 (4.3) | 3.8 (3.4) | 2.5 (1.7) | F(2;56) = 2.26 | 0.114 |
Location lesions | χ2(6) = 5.51 | 0.48 | ||||
Others | 5 (8.5) | 2 (10.0) | 3 (15.0) | 0 (0.0) | ||
Buccal mucosa | 33 (55.9) | 9 (45.0) | 10 (50.0) | 14 (73.7) | ||
Gums | 15 (25.4) | 6 (30.0) | 5 (25.0) | 4 (21.1) | ||
Tongue | 6 (10.2) | 3 (15.0) | 2 (10.0) | 1 (5.3) | ||
CLINICAL LESIONS | χ2(4) = 2.447 | 0.654 | ||||
Reticular | 25 (42.4) | 7 (35.0) | 10 (50.0) | 8 (42.1) | ||
Atrophic | 20 (33.9) | 6 (30.0) | 7 (35.0) | 7 (36.8) | ||
Erosive | 14 (23.7) | 7 (35.0) | 3 (15.0) | 4 (21.1) |
Visit, Mean (SD) | Within-Subject Effects † | |||||||
---|---|---|---|---|---|---|---|---|
1 | 2 | 3 | 4 | 5 | 6 | Visit | Treatment * Visit | |
F(df); p-Value (η2) | F(df); p-Value (η2) | |||||||
PAIN SCALE | F(5;275) = 46.14; p < 0.001 (0.456) | F(10;275) = 5.80; p < 0.001 (0.174) | ||||||
Treat. 1 | 6.70 (3.44) | 5.65 (3.07) | 4.30 (2.83) | 2.80 (1.94) | 1.95 (1.79) | 2.05 (2.28) | ||
Treat. 2 | 6.50 (2.86) | 5.50 (2.72) | 4.25 (2.71) | 3.25 (2.57) | 3.10 (2.17) | 3.20 (2.38) | ||
Treat. 3 | 4.94 (3.02) | 4.17 (2.50) | 3.33 (2.06) | 2.83 (2.12) | 3.61 (2.93) | 4.06 (2.98) | ||
Total | 6.09 (3.16) | 5.14 (2.81) | 3.98 (2.57) | 2.97 (2.20) | 2.86 (2.39) | 3.07 (2.64) |
Visit | Difference in Means (p-Value) | ||
---|---|---|---|
Treatment 1 | Treatment 2 | Treatment 3 | |
1-2 | 1.05 (0.006) | 1.00 (0.011) | 0.77 (0.162) |
1-3 | 2.40 (<0.001) | 2.25 (<0.001) | 1.61 (0.029) |
1-4 | 3.90 (<0.001) | 3.25 (<0.001) | 2.11 (0.001) |
1-5 | 4.75 (<0.001) | 3.40 (<0.001) | 1.33 (0.272) |
1-6 | 4.65 (<0.001) | 3.30 (<0.001) | 0.88 (1) |
2-3 | 1.35 (0.012) | 1.25 (0.026) | 0.83 (0.632) |
2-4 | 2.85 (<0.001) | 2.25 (<0.001) | 1.33 (0.095) |
2-5 | 3.70 (<0.001) | 2.40 (0.001) | 0.55 (1) |
2-6 | 3.60 (<0.001) | 2.30 (0.009) | 0.11 (1) |
3-4 | 1.50 (<0.001) | 1.00 (0.044) | 0.5 (1) |
3-5 | 2.35 (<0.001) | 1.15 (0.047) | −0.2 (1) |
3-6 | 2.25 (0.001) | 1.05 (0.048) | −0.7 (1) |
4-5 | 0.85 (0.143) | 0.15 (1) | −0.7 (0.352) |
4-6 | 0.75 (1) | 0.05 (1) | −1.2 (0.223) |
5-6 | −0.1 (1) | −0.1 (1) | −0.4 (1) |
Visit, Mean (SD) | Within-Subject Effects † | ||||
---|---|---|---|---|---|
Initial (1) | 1 Month (2) | 3 Months (3) | Visit | Treatment * visit | |
F(df); p-Value (eta2) | F(df); p-Value (eta2) | ||||
OHIP-14 | F(2;110) = 46.20; p < 0.001 (0.457) | F(4;110) = 2.53; p = 0.046 (0.088) | |||
Treat. 1 | 18.05 (9.43) | 12.75 (7.17) | 9.10 (5.21) | ||
Treat. 2 | 22.55 (9.12) | 17.50 (9.22) | 14.30 (7.95) | ||
Treat. 3 | 25.94 (12.35) | 23.94 (12.26) | 22.06 (12.15) | ||
Total | 22.05 (10.64) | 17.86 (10.54) | 14.91 (10.11) | ||
Anxiety | F(2;110) = 25.75; p < 0.001 (0.319) | F(4;110) = 4.39; p = 0.002 (0.138) | |||
Treat. 1 | 12.35 (3.79) | 9.05 (5.28) | 7.20 (4.23) | ||
Treat. 2 | 12.55 (3.53) | 9.05 (2.56) | 6.60 (4.37) | ||
Treat. 3 | 10.94 (3.40) | 11.06 (3.64) | 10.17 (3.37) | ||
Total | 11.98 (3.59) | 9.67 (4.04) | 7.91 (4.25) | ||
Depression | F(2;110) = 9.74; p < 0.001 (0.151) | F(4;110) = 0.67; p = 0.615 (0.024) | |||
Treat. 1 | 4.85 (5.06) | 4.55 (4.92) | 4.25 (4.44) | ||
Treat. 2 | 4.00 (2.36) | 3.70 (2.36) | 3.40 (2.23) | ||
Treat. 3 | 6.00 (4.02) | 5.87 (3.43) | 5.33 (2.98) | ||
Total | 4.91 (3.98) | 4.71 (3.75) | 4.33 (3.35) |
Follow-Up | Difference in Means (p-Value) | ||
---|---|---|---|
Treat. 1 | Treat. 2 | Treat. 3 | |
OHIP-14 Initial-1 month | 5.30 (<0.001) | 5.05 (<0.001) | 2 (0.363) |
Initial-3 months | 8.95 (<0.001) | 8.25 (<0.001) | 3.88 (0.065) |
1 month-3 months | 3.65 (0.003) | 3.20 (0.01) | 1.88 (0.27) |
Anxiety Initial-1 month | 3.30 (0.001) | 3.50 (<0.001) | −0.11 (1) |
Initial-3 months | 5.15 (<0.001) | 5.95 (<0.001) | 0.77 (1) |
1 month-3 months | 1.85 (0.044) | 2.45 (0.029) | 0.88 (1) |
Depression Initial-1 month | 0.3 (0.449) | 0.3 (0.449) | 0.13 (0.388) |
Initial-3 months | 0.6 (0.385) | 0.6 (0.385) | 0.67 (0.119) |
1 month-3 months | 0.3 (0.95) | 0.3 (0.95) | 0.54 (0.303) |
Visit | Difference in Means (p-Value) | ||
---|---|---|---|
Treat. 1 vs. Treat. 2 | Treat. 1 vs. Treat. 3 | Treat. 2 vs. Treat. 3 | |
OHIP-14 Initial | −4.50 (0.521) | 7.89 (0.066) | −3.39 (0.948) |
1 month | −4.75 (0.379) | −11.19 (0.002) | −6.44 (0.135) |
3 Months | −5.20 (0.198) | −12.96 (<0.001) | −7.76 (0.026) |
Anxiety Initial | −0.20 (1) | 1.41 (0.698) | 1.61 (0.521) |
1 month | 0.00 (1) | −2.01 (0.385) | −2.01 (0.385) |
3 months | 0.60 (1) | −2.97 (0.083) | −3.57 (0.026) |
Depression Initial | 0.85 (1) | −1.15 (1) | −2.00 (0.38) |
1 month | 0.85 (1) | −1.12 (1) | −1.97 (0.331) |
3 months | 0.85 (1) | −0.58 (1) | −1.43 (0.582) |
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Salinas-Gilabert, C.; Gómez García, F.; Galera Molero, F.; Pons-Fuster, E.; Vander Beken, S.; Lopez Jornet, P. Photodynamic Therapy, Photobiomodulation and Acetonide Triamcinolone 0.1% in the Treatment of Oral Lichen Planus: A Randomized Clinical Trial. Pharmaceutics 2023, 15, 30. https://doi.org/10.3390/pharmaceutics15010030
Salinas-Gilabert C, Gómez García F, Galera Molero F, Pons-Fuster E, Vander Beken S, Lopez Jornet P. Photodynamic Therapy, Photobiomodulation and Acetonide Triamcinolone 0.1% in the Treatment of Oral Lichen Planus: A Randomized Clinical Trial. Pharmaceutics. 2023; 15(1):30. https://doi.org/10.3390/pharmaceutics15010030
Chicago/Turabian StyleSalinas-Gilabert, Carmen, Francisco Gómez García, Fe Galera Molero, Eduardo Pons-Fuster, Seppe Vander Beken, and Pia Lopez Jornet. 2023. "Photodynamic Therapy, Photobiomodulation and Acetonide Triamcinolone 0.1% in the Treatment of Oral Lichen Planus: A Randomized Clinical Trial" Pharmaceutics 15, no. 1: 30. https://doi.org/10.3390/pharmaceutics15010030
APA StyleSalinas-Gilabert, C., Gómez García, F., Galera Molero, F., Pons-Fuster, E., Vander Beken, S., & Lopez Jornet, P. (2023). Photodynamic Therapy, Photobiomodulation and Acetonide Triamcinolone 0.1% in the Treatment of Oral Lichen Planus: A Randomized Clinical Trial. Pharmaceutics, 15(1), 30. https://doi.org/10.3390/pharmaceutics15010030