NCT05620316 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Carra MC, Huynh N, Lavigne G
Sleep bruxism: a comprehensive overview for the dental clinician interested in sleep medicine. Dent Clin North Am. 2012 Apr;56(2):387-413. doi: 10.1016/j.cden.2012.01.003. Review.
Lavigne GJ, Khoury S, Abe S, Yamaguchi T, Raphael K
Bruxism physiology and pathology: an overview for clinicians. J Oral Rehabil. 2008 Jul;35(7):476-94. doi: 10.1111/j.1365-2842.2008.01881.x. Review.
Lobbezoo F, Ahlberg J, Glaros AG, Kato T, Koyano K, Lavigne GJ, de Leeuw R, Manfredini D, Svensson P, Winocur E
Bruxism defined and graded: an international consensus. J Oral Rehabil. 2013 Jan;40(1):2-4. doi: 10.1111/joor.12011. Epub 2012 Nov 4.
Manfredini D, Ahlberg J, Winocur E, Lobbezoo F
Management of sleep bruxism in adults: a qualitative systematic literature review. J Oral Rehabil. 2015 Nov;42(11):862-74. doi: 10.1111/joor.12322. Epub 2015 Jun 11. Review.
Sellin LC, Thesleff S
Pre- and post-synaptic actions of botulinum toxin at the rat neuromuscular junction. J Physiol. 1981 Aug;317:487-95.
Tan EK, Jankovic J
Treating severe bruxism with botulinum toxin. J Am Dent Assoc. 2000 Feb;131(2):211-6.

Evaluation of the Efficacy of Low-Dose Botulinum Toxin Injection Into the Masseter Muscle for the Treatment of Nocturnal Bruxism: A Randomized Controlled Clinical Trial

Details for clinical trial NCT05620316

Clinical trial NCT05620316 - References