Efficacy of Botulinum Toxin Type-A I in the Improvement of Mandibular Motion and Muscle Sensibility in Myofascial Pain TMD Subjects: A Randomized Controlled Trial
Abstract
:1. Introduction
2. Results
2.1. Subjects
2.2. Mandibular Motion
2.3. Muscle Pain
3. Discussion
4. Conclusions
5. Methods
5.1. Inclusion Criteria
- Years of age: 18–45;
- A diagnosis of MFP according to the RDC/TMD classification [3]
- No significant pain relief after at least three months of previous treatment;
- A baseline pain intensity of at least 50 on a visual analogue scale (VAS: 0–100);
- Subjects were also included if they presented other non-painful TMD diagnoses besides MFP.
5.2. Exclusion Criteria
- History of trauma in the face and neck area;
- Dental pain in the last 6 months;
- Systemic diseases (arthritis and arthrosis) and major psychiatric disorders;
- Current use of drugs acting on neuromuscular junctions;
- Contraindication or hypersensitivity to BoNT-A;
- Received anti-tetanus vaccine in the 3 months before the start of the clinical trial.
5.3. Treatments
5.4. RDC/TMD Axis I Assessment
5.5. Data Evaluation and Statistical Analyses
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Acknowledgments
Conflicts of Interest
References
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Time | ||||||
---|---|---|---|---|---|---|
Baseline | 28 Days | 180 Days | ||||
Groups | Mean | SD | Mean | SD | Mean | SD |
BoNTA-L | 31.9 aB | 8.7 | 33.6 aB | 8.8 | 38.3 aA | 7.5 |
BoNTA-M | 32.4 aB | 9.4 | 35.0 aB | 7.7 | 40.7 aA | 7.6 |
BoNTA-H | 32.6 aB | 8.9 | 35.0 aB | 9.2 | 39.0 aA | 8.1 |
SS | 36.2 aB | 6.1 | 37.6 aB | 6.6 | 34.0 bA | 9.0 |
Time | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|
Baseline | 28 Days | 180 Days | ||||||||
Groups | Median | Mn | Mx | Median | Mn | Mx | Median | Mn | Mx | |
Unassisted | BoNTA-L | 41.0 aB | 28.0 | 59.0 | 42.0 aB | 29.0 | 58.0 | 44.5 aA | 31.0 | 60.0 |
BoNTA-M | 43.0 aB | 29.0 | 54.0 | 43.5 aB | 30.0 | 52.0 | 45.0 aA | 35.0 | 60.0 | |
BoNTA-H | 41.0 aB | 26.0 | 50.0 | 43.0 aB | 25.0 | 52.0 | 46.0 aA | 23.0 | 55.0 | |
SS | 41.5 aB | 35.0 | 55.0 | 42.0 aB | 50.0 | 50.0 | 39.0 bB | 20.0 | 45.0 | |
Assisted | BoNTA-L | 43.0 aB | 30.0 | 60.0 | 43.0 aB | 31.0 | 58.0 | 47.0 aA | 33.0 | 62.0 |
BoNTA-M | 47.0 aB | 30.0 | 57.0 | 45.5 aB | 31.0 | 55.0 | 48.5 aA | 35.0 | 61.0 | |
BoNTA-H | 44.0 aB | 30.0 | 55.0 | 47.0 aB | 30.0 | 53.0 | 50.0 aA | 31.0 | 57.0 | |
SS | 42.5 aB | 33.0 | 56.0 | 43.5 aB | 34.0 | 51.0 | 41.5 bB | 22.0 | 47.0 |
Time | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|
Baseline | 28 Days | 180 Days | ||||||||
Groups | Median | Mn | Mx | Median | Mn | Mx | Median | Mn | Mx | |
Right | BoNTA-L | 9.5 aA | 2.0 | 15.0 | 9.0 aA | 3.0 | 12.0 | 11.0 aB | 6.0 | 13.0 |
BoNTA-M | 9.0 aA | 5.0 | 12.0 | 9.0 aA | 6.0 | 14.0 | 10.0 aB | 7.0 | 13.0 | |
BoNTA-H | 8.5 aA | 4.0 | 14.0 | 9.5 aA | 4.0 | 14.0 | 10.5 aB | 5.0 | 15.0 | |
SS | 8.0 aA | 3.0 | 11.0 | 8.5 aA | 5.0 | 14.0 | 9.0 bA | 5.0 | 12.0 | |
Left | BoNTA-L | 8.0 aA | 0.0 | 13.0 | 9.0 aA | 4.0 | 13.0 | 9.5 aB | 4.0 | 14.0 |
BoNTA-M | 8.0 aA | 2.0 | 12.0 | 9.0 aA | 6.0 | 15.0 | 10.0 aB | 8.0 | 15.0 | |
BoNTA-H | 9.5 aA | 4.0 | 12.0 | 9.5 aA | 4.0 | 15.0 | 10.0 aB | 6.0 | 15.0 | |
SS | 8.0 aA | 3.0 | 13.0 | 8.5 aA | 5.0 | 15.0 | 8.5 bA | 5.0 | 15.0 |
Time | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|
Baseline | 28 Days | 180 Days | ||||||||
Groups | Median | Mn | Mx | Median | Mn | Mx | Median | Mn | Mx | |
Right | BoNTA-L | 2.0 aA | 0.0 | 3.0 | 1.0 bB | 0.0 | 12.0 | 0.5 bB | 0.0 | 2.0 |
BoNTA-M | 1.0 aA | 0.0 | 3.0 | 0.0 bB | 0.0 | 14.0 | 0.0 bB | 0.0 | 3.0 | |
BoNTA-H | 2.0 aA | 0.0 | 3.0 | 0.5 bB | 0.0 | 14.0 | 0.0 bB | 0.0 | 3.0 | |
SS | 2.0 aA | 1.0 | 3.0 | 2.0 aA | 0.0 | 14.0 | 2.0 aA | 0.0 | 3.0 | |
Left | BoNTA-L | 1.5 aA | 0.0 | 3.0 | 0.0 bB | 0.0 | 2.0 | 0.5 bB | 0.0 | 3.0 |
BoNTA-M | 1.0 aA | 0.0 | 3.0 | 0.0 bB | 0.0 | 3.0 | 0.0 bB | 0.0 | 3.0 | |
BoNTA-H | 2.0 aA | 0.0 | 3.0 | 0.0 bB | 0.0 | 3.0 | 0.0 bB | 0.0 | 2.0 | |
SS | 1.0 aA | 0.0 | 3.0 | 2.0 aA | 0.0 | 3.0 | 2.0 aA | 0.0 | 3.0 |
Time | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|
Baseline | 28 Days | 180 Days | ||||||||
Groups | Median | Mn | Mx | Median | Mn | Mx | Median | Mn | Mx | |
Right | BoNTA-L | 2.5 aA | 0.0 | 3.0 | 1.0 bB | 0.0 | 2.0 | 0.0 aB | 0.0 | 2.0 |
BoNTA-M | 2.0 aA | 0.0 | 3.0 | 1.0 bB | 0.0 | 2.0 | 0.0 aB | 0.0 | 2.0 | |
BoNTA-H | 2.0 aA | 0.0 | 3.0 | 0.0 bB | 0.0 | 3.0 | 0.5 aB | 0.0 | 2.0 | |
SS | 2.0 aA | 0.0 | 3.0 | 2.0 aA | 0.0 | 3.0 | 2.0 bA | 0.0 | 3.0 | |
Left | BoNTA-L | 2.0 aA | 0.0 | 3.0 | 1.0 bB | 0.0 | 3.0 | 0.5 aB | 0.0 | 2.0 |
BoNTA-M | 1.5 aA | 0.0 | 3.0 | 0.0 bB | 0.0 | 3.0 | 0.0 aB | 0.0 | 2.0 | |
BoNTA-H | 2.0 aA | 0.0 | 3.0 | 0.5 bB | 0.0 | 3.0 | 0.0 aB | 0.0 | 2.0 | |
SS | 1.5 aA | 0.0 | 3.0 | 1.0 bA | 0.0 | 3.0 | 1.5 bA | 0.0 | 3.0 |
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De la Torre Canales, G.; Poluha, R.L.; Pinzón, N.A.; Da Silva, B.R.; Almeida, A.M.; Ernberg, M.; Manso, A.C.; Bonjardim, L.R.; Rizzatti-Barbosa, C.M. Efficacy of Botulinum Toxin Type-A I in the Improvement of Mandibular Motion and Muscle Sensibility in Myofascial Pain TMD Subjects: A Randomized Controlled Trial. Toxins 2022, 14, 441. https://doi.org/10.3390/toxins14070441
De la Torre Canales G, Poluha RL, Pinzón NA, Da Silva BR, Almeida AM, Ernberg M, Manso AC, Bonjardim LR, Rizzatti-Barbosa CM. Efficacy of Botulinum Toxin Type-A I in the Improvement of Mandibular Motion and Muscle Sensibility in Myofascial Pain TMD Subjects: A Randomized Controlled Trial. Toxins. 2022; 14(7):441. https://doi.org/10.3390/toxins14070441
Chicago/Turabian StyleDe la Torre Canales, Giancarlo, Rodrigo Lorenzi Poluha, Natalia Alvarez Pinzón, Bruno Rodrigues Da Silva, Andre Mariz Almeida, Malin Ernberg, Ana Cristina Manso, Leonardo Rigoldi Bonjardim, and Célia Marisa Rizzatti-Barbosa. 2022. "Efficacy of Botulinum Toxin Type-A I in the Improvement of Mandibular Motion and Muscle Sensibility in Myofascial Pain TMD Subjects: A Randomized Controlled Trial" Toxins 14, no. 7: 441. https://doi.org/10.3390/toxins14070441