Braumann B, Keilig L, Bourauel C, Jäger A Three-dimensional analysis of morphological changes in the maxilla of patients with cleft lip and palate. Cleft Palate Craniofac J. 2002 Jan;39(1):1-11.
Clark JM, Skoner JM, Wang TD Repair of the unilateral cleft lip/nose deformity. Facial Plast Surg. 2003 Feb;19(1):29-40.
Singh GD, Levy-Bercowski D, Santiago PE Three-dimensional nasal changes following nasoalveolar molding in patients with unilateral cleft lip and palate: geometric morphometrics. Cleft Palate Craniofac J. 2005 Jul;42(4):403-9.
Sommerlad BC International confederation for cleft lip and palate and related craniofacial anomalies task force report: palatoplasty in the speaking individual with unrepaired cleft palate. Cleft Palate Craniofac J. 2014 Nov;51(6):e122-8. doi: 10.1597/14-124. Epub 2014 Jul 9.
Efficacy of Nasoalveolar Molding Therapy for Treatment of Unilateral Cleft Lip and Palate in Egyptian Infants
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
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.
