NCT03685318 - 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)

Gebauer DP, Williamson RA, Wallman KE, Dawson BT
The effect of mouthguard design on respiratory function in athletes. Clin J Sport Med. 2011 Mar;21(2):95-100. doi: 10.1097/JSM.0b013e31820428b0.
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
Lloyd JD, Nakamura WS, Maeda Y, Takeda T, Leesungbok R, Lazarchik D, Dorney B, Gonda T, Nakajima K, Yasui T, Iwata Y, Suzuki H, Tsukimura N, Churei H, Kwon KR, Choy MMH, Rock JB
Mouthguards and their use in sports: Report of the 1st International Sports Dentistry Workshop, 2016. Dent Traumatol. 2017 Dec;33(6):421-426. doi: 10.1111/edt.12375. Review.
Maeda Y, Machi H, Tsugawa T
Influences of palatal side design and finishing on the wearability and retention of mouthguards. Br J Sports Med. 2006 Dec;40(12):1006-8. Epub 2006 Sep 25.
Parker K, Marlow B, Patel N, Gill DS
A review of mouthguards: effectiveness, types, characteristics and indications for use. Br Dent J. 2017 Apr 21;222(8):629-633. doi: 10.1038/sj.bdj.2017.365. Review.
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 Shortening the Palatal Extension of the Mouthguard on the Degree of Satisfaction of Water Polo Players: A Randomized Crossover Study

Clinical trial NCT03685318 - References