NCT03922438 - 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)

Isik D, Atik B, Tan O, Aktar S, Dogan M, Goktas U
Primary repair of the alveolar cleft. J Craniofac Surg. 2011 Nov;22(6):2224-6. doi: 10.1097/SCS.0b013e31823200c3.
Kuna SK, Srinath N, Naveen BS, Hasan K
Comparison of Outcome of Modified Millard's Incision and Delaire's Functional Method in Primary Repair of Unilateral Cleft Lip: A Prospective Study. J Maxillofac Oral Surg. 2016 Jun;15(2):221-8. doi: 10.1007/s12663-015-0816-z. Epub 2015 Jul 25.
Marcusson A, Akerlind I, Paulin G
Quality of life in adults with repaired complete cleft lip and palate. Cleft Palate Craniofac J. 2001 Jul;38(4):379-85.
Mossey P
Epidemiology underpinning research in the aetiology of orofacial clefts. Orthod Craniofac Res. 2007 Aug;10(3):114-20.
Mossey PA, Modell B
Epidemiology of oral clefts 2012: an international perspective. Front Oral Biol. 2012;16:1-18. doi: 10.1159/000337464. Epub 2012 Jun 25. Review.
Park YW, Kwon KJ, Kim MK
Double-layered reconstruction of the nasal floor in complete cleft deformity of the primary palate using superfluous lip tissue. Maxillofac Plast Reconstr Surg. 2015 Oct 13;37(1):35. doi: 10.1186/s40902-015-0035-z. eCollection 2015 Dec.
Wehby GL, Cassell CH
The impact of orofacial clefts on quality of life and healthcare use and costs. Oral Dis. 2010 Jan;16(1):3-10. doi: 10.1111/j.1601-0825.2009.01588.x. Epub 2009 Jul 27. Review.
Wilhelmsen HR, Musgrave RH
Complications of cleft lip surgery. Cleft Palate J. 1966 Jul;3:223-31.

Use of Cleft Margin Flap With Anterior Palatal Closure for Closure of Naso-alveolar Defect During Primary Cleft Lip Repair (Pilot Study).

Clinical trial NCT03922438 - References