Response to Treatment with Melatonin and Clonazepam versus Placebo in Patients with Burning Mouth Syndrome
Abstract
:1. Introduction
2. Material and Methods
2.1. Study Protocol: Clinical Variables and Data Compilation
- Burning sensation visual analog scale (VAS pain): the patient scores burning sensation on a VAS from 0 to 10, where 0 = no burning sensation and 10 = maximum burning sensation [38].
- Xerostomia score (VAS xeros): the patient scores xerostomia (dry mouth) on a VAS from 0 to 10, where 0 = no xerostomia and 10 = maximum xerostomia.
- Oral Health Impact Profile 14 (OHIP-14)(Spanish version): this questionnaire is composed of 7 dimensions: functional limitation, physical discomfort, psychological discomfort, physical disability, psychological disability, social disability, and handicaps. Each dimension comprises two questions (with a total of 14 questions), and the answers are scored from 0 to 4 (0 = lowest level and 4 = highest level). The higher the score, the poorer the oral quality of life of the patient [39].
- Hospital Anxiety and Depression Scale (HADS): this instrument consists of two subscales that respectively assess anxiety state (HADS-A) and depressive state (HADS-D). Each subscale has 7 items scored from 0 to 3, where a total score of over 10 reflects the presence of anxiety or depression, scores between 8 and 10 are borderline, and a score of under 7 indicates the absence of anxiety or depression [40].
- Pittsburg Sleep Quality Index: this instrument consists of 19 questions divided into 7 sections, with each section addressing a specific characteristic of the patient sleep pattern: subjective quality of sleep, latency of sleep, duration of sleep, usual efficiency of sleep, alterations of sleep, use of medication to sleep, and daytime dysfunction. Each section receives a score of 0–3, where 0 = no problems and 3 = great problems. The final score corresponds to the sum of the scores of the 7 sections, yielding a maximum score of 21 points. A score of 5 or less is indicative of satisfactory quality of sleep, while scores of over 5 are indicative of sleep disorders [41].
- Epworth daytime sleepiness scale: this scale comprises 8 questions that simulate situations in which the patient is asked to score the probability of experiencing sleepiness. The result of the questionnaire is the sum of the individual scores of the 8 questions, and higher scores are indicative of a greater probability of daytime sleepiness [42].
2.2. Sialometry
2.3. Biochemical Analysis
2.4. Statistical Analysis
3. Results
4. Discussion
5. Study Limitations
6. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Melatonin | Clonazepam | Placebo | p | |
---|---|---|---|---|
Gender (%) FemaleMale | 19 (82.61) 4 (17.39) | 15 (92) 1 (6.25) | 23 (92) 2 (8) | p > 0.05 |
Age (mean;SD) | 57.68 (10.32) | 63.81 (10.69) | 60.40 (13.8) | p > 0.05 |
Smoking n (%) Smoking No Smoking Ex Smoking | 6 (26.1) 13 (56.5) 4 (17.4) | 3 (18.8) 13 (81.3) 0 (0) | 4 (16) 17 (68) 4 (16) | p > 0.05 |
Alcohol n (%) less than once a week Once a day weekends | 11 (47.8) 6 (26.1) 6 (26.1) | 15 (93.7) 0 (0) 1 (6.3) | 20 (80) 2 (8) 3 (12) | p < 0.05 |
Oral hygiene (brushing) n (%) No Once a day Twice a day Three times a day | 0 (0) 13 (59.9) 0(0) 9 (39.1) | 1 (6.3) 7 (43.8) 1 (6.3) 7 (43.8) | 1(4) 10 (40) 1 (4) 13 (52) | p > 0.05 |
Melatonin | p | Placebo | p | Clonazepam | p | ||||
---|---|---|---|---|---|---|---|---|---|
Pre | Post | Pre | Post | Pre | Post | ||||
Oxytocin | 804.4 (562–1902) | 1581 (544.6–2128) | 0.339 | 1417 (907.6–2491) | 1627 (768.4–2388) | 0.953 | 804.4 (562–3065) | 1581 (544.6–2467) | 0.910 |
ADA | 3.1 (0.75–5.7) | 2.8 (0.75–6.575) | 0.718 | 3.8 (1.3–11.1) | 3.7 (1.4–11.5) | 0.992 | 3.1 (0.75–7.525) | 2.8 (0.75–5.65) | 0.945 |
Ferritin | 6$(2–13.78) | 5.75 (3.075–22.18) | 0.266 | 9 (4.25–12.33) | 8.45 (2.925–19.7) | 0.252 | 6 (2–22.63) | 5.75 (3.075–17.55) | 0.219 |
SAA (U/L) | 198,760 (132,680–368,600) | 196,720 (111,080–359,160) | 0.266 | 181,520 (97,400–364,520) | 166,960 (81,680–232,920) | 0.891 | 198,760 (132,680–395,180) | 196,720 (111,080–382,800) | 0.910 |
PT | 121.9 (78.35–208.4) | 149.6 (101.2–222.1) | 0.043 | 185.9 (99.38–309.1) | 130 (90.16–332.2) | 0.679 | 121.9 (78.35–183.2) | 149.6 (101.2–217.5) | 0.250 |
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Castillo-Felipe, C.; Tvarijonaviciute, A.; López-Arjona, M.; Pardo-Marin, L.; Pons-Fuster, E.; López-Jornet, P. Response to Treatment with Melatonin and Clonazepam versus Placebo in Patients with Burning Mouth Syndrome. J. Clin. Med. 2022, 11, 2516. https://doi.org/10.3390/jcm11092516
Castillo-Felipe C, Tvarijonaviciute A, López-Arjona M, Pardo-Marin L, Pons-Fuster E, López-Jornet P. Response to Treatment with Melatonin and Clonazepam versus Placebo in Patients with Burning Mouth Syndrome. Journal of Clinical Medicine. 2022; 11(9):2516. https://doi.org/10.3390/jcm11092516
Chicago/Turabian StyleCastillo-Felipe, Candela, Asta Tvarijonaviciute, Marina López-Arjona, Luis Pardo-Marin, Eduardo Pons-Fuster, and Pia López-Jornet. 2022. "Response to Treatment with Melatonin and Clonazepam versus Placebo in Patients with Burning Mouth Syndrome" Journal of Clinical Medicine 11, no. 9: 2516. https://doi.org/10.3390/jcm11092516