NCT03395015 - 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 Ladeira PR, Alonso N
Protocols in cleft lip and palate treatment: systematic review. Plast Surg Int. 2012;2012:562892. doi: 10.1155/2012/562892. Epub 2012 Nov 1.
Eichenberger M, Staudt CB, Pandis N, Gnoinski W, Eliades T
Facial attractiveness of patients with unilateral cleft lip and palate and of controls assessed by laypersons and professionals. Eur J Orthod. 2014 Jun;36(3):284-9. doi: 10.1093/ejo/cjt047. Epub
Iliopoulos C, Mitsimponas K, Lazaridou D, Neukam FW, Stelzle F
A retrospective evaluation of the aesthetics of the nasolabial complex after unilateral cleft lip repair using the Tennison-Randall technique: a study of 44 cases treated in a single cleft ce
Mosmuller DG, Bijnen CL, Kramer GJ, Disse MA, Prahl C, Kuik DJ, Niessen FB, Don Griot JP
The Asher-McDade Aesthetic Index in Comparison With Two Scoring Systems in Nonsyndromic Complete Unilateral Cleft Lip and Palate Patients. J Craniofac Surg. 2015 Jun
Sharma VP, Bella H, Cadier MM, Pigott RW, Goodacre TE, Richard BM
Outcomes in facial aesthetics in cleft lip and palate surgery: a systematic review. J Plast Reconstr Aesthet Surg. 2012 Sep;65(9):1233-45. doi: 10.1016/j.bjps.2012.04.001. Epub 2012 May 15
Stebel A, Desmedt D, Bronkhorst E, Kuijpers MA, Fudalej PS
Rating nasolabial appearance on three-dimensional images in cleft lip and palate: a comparison with standard photographs. Eur J Orthod. 2016 Apr;38(2):197-201. doi: 10.1093/ejo/cjv024. Epub 2015

Efficacia Del Trattamento Chirurgico Maxillo-facciale Sul Volto Dei Bambini Con Labiopalatoschisi: Valutazioni Estetiche ed Ortodontiche

Clinical trial NCT03395015 - References