الفهرس | Only 14 pages are availabe for public view |
Abstract A balanced, randomized, parallel-group, single-blinded, controlled trial was carried out on infants with unilateral complete cleft lip and palate with the primary outcome of evaluating parents{u2019} satisfaction to 2 different NAM designs, as well as taping in comparison to a control group with no use of any PSIO. Furthermore, two other secondary outcomes were assessed; the ability of the three different interventions (M-NAM, D-NAM,Taping) to improve nose and lip esthetics, as well as maxillary arch dimensions Sample size calculation resulted in 14 infants per group raised to 17 per group to overcome any possible drop-outs.Sixty-three infants with age range of 1-30 days were recruited in the current study. After proper randomization (sequence generation, allocation concealment and implementation), the infants were assigned into one of the 4 groups; modified Grayson{u2019}s NAM (M-NAM), Digital NAM (D-NAM), taping and no treatment control groups. In the M-NAM group, activation movements were done on the maxillary model, rather than on the fitting surface of the intraoral plate. Upon the modified model, the intraoral plate was constructed using hard acrylic resin. The nasal stent was constructed with 0.8 mm stainless steel wire,ended with a kidney shaped loop covered with acrylic resin. The 2 sides extraoral tapes with elastics were omitted. Acrylic button was still in place to facilitate appliance handling.The D-NAM (the digital version of the M-NAM), had the model modification and appliance construction virtually done using a software followed by 3D printing of the intraoral plate. Infants assigned to the taping group received only tapes.The 3 intervention groups were compared to the no treatment control |