NCT03845621 - 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)

Flores-Figueiras C, Zamora-Olave C, Willaert E, Martinez-Gomis J
Effect of thickness and occlusal accommodation on the degree of satisfaction with mouthguard use among water polo players: A randomized crossover trial. Dent Traumatol. 2020 Dec;36(6):670-6
Geary JL, Clifford TJ, Kinirons MJ
Occlusal accommodation and mouthguards for prevention of orofacial trauma. Oral Health Prev Dent. 2009;7(1):55-9.
Gómez-Gimeno À, Zamora-Olave C, Cordobés-Navarro M, Willaert E, Martinez-Gomis J
Satisfaction with shortening the palatal extension of a mouthguard for water polo players: A randomized crossover study. Dent Traumatol. 2019 Apr;35(2):135-141. doi: 10.1111/edt.12455. Epub 2019 Jan 7.
Zamora-Olave C, Willaert E, Montero-Blesa A, Riera-Punet N, Martinez-Gomis J
Risk of orofacial injuries and mouthguard use in water polo players. Dent Traumatol. 2018 Dec;34(6):406-412. doi: 10.1111/edt.12434. Epub 2018 Oct 10.

Effect of Occlusal Accommodation of the Mouthguard on the Degree of Satisfaction of Water Polo Players: A Randomized Crossover Study

Clinical trial NCT03845621 - References