NCT05248087 - 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)

De Felippe NL, Da Silveira AC, Viana G, Smith B
Influence of palatal expanders on oral comfort, speech, and mastication. Am J Orthod Dentofacial Orthop. 2010 Jan;137(1):48-53. doi: 10.1016/j.ajodo.2008.01.023.
Feldmann I, Bazargani F
Pain and discomfort during the first week of rapid maxillary expansion (RME) using two different RME appliances: A randomized controlled trial. Angle Orthod. 2017 May;87(3):391-396. doi: 10.2319/091216-686.1. Epub 2016 Dec 28.
Halicioglu K, Kiki A, Yavuz I
Subjective symptoms of RME patients treated with three different screw activation protocols: a randomised clinical trial. Aust Orthod J. 2012 Nov;28(2):225-31.
Saleh M, Hajeer MY, Al-Jundi A
Assessment of pain and discomfort during early orthodontic treatment of skeletal Class III malocclusion using the Removable Mandibular Retractor Appliance. Eur J Paediatr Dent. 2013 Jun;14(2):119-24.
Ugolini A, Cossellu G, Farronato M, Silvestrini-Biavati A, Lanteri V
A multicenter, prospective, randomized trial of pain and discomfort during maxillary expansion: Leaf expander versus hyrax expander. Int J Paediatr Dent. 2020 Jul;30(4):421-428. doi: 10.1111/ipd.12612. Epub 2020 Jan 20.

Assessment of Patient-centered Outcomes Associated With the Expansion of Skeletally Constricted Upper Jaw in the Adolescents Using Two Types of Expanders: A Randomized Controlled Trial

Details for clinical trial NCT05248087

Clinical trial NCT05248087 - References