NCT02805764 - 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)

Belfor TR, Singh GD
Developing dental arch symmetry using the Homeoblock device. Int J Orthod Milwaukee. 2004 Fall;15(3):27-30.
Chen H, Lowe AA, de Almeida FR, Fleetham JA, Wang B
Three-dimensional computer-assisted study model analysis of long-term oral-appliance wear. Part 2. Side effects of oral appliances in obstructive sleep apnea patients. Am J Orthod Dentofacial Orthop. 2008 Sep;134(3):408-17. doi: 10.1016/j.ajodo.2006.10.031.
Corruccini RS
An epidemiologic transition in dental occlusion in world populations. Am J Orthod. 1984 Nov;86(5):419-26.
Kushida CA, Efron B, Guilleminault C
A predictive morphometric model for the obstructive sleep apnea syndrome. Ann Intern Med. 1997 Oct 15;127(8 Pt 1):581-7.
Li KK, Riley RW, Guilleminault C
An unreported risk in the use of home nasal continuous positive airway pressure and home nasal ventilation in children: mid-face hypoplasia. Chest. 2000 Mar;117(3):916-8.
Machado-Júnior AJ, Zancanella E, Crespo AN
Rapid maxillary expansion and obstructive sleep apnea: A review and meta-analysis. Med Oral Patol Oral Cir Bucal. 2016 Jul 1;21(4):e465-9. Review.
Singh GD, Callister JD
Effect of a maxillary appliance in an adult with obstructive sleep apnea: a case report. Cranio. 2013 Jul;31(3):171-5.
Singh GD, Wendling S, Chandrashekhar R
Midfacial development in adult obstructive sleep apnea. Dent Today. 2011 Jul;30(7):124-7.

Changes in Upper Airway Anatomy, Quality of Life Measures, and Polysomnographic Parameters Using A Functional Dental Appliance

Clinical trial NCT02805764 - References