الفهرس 
AcknowledgementOnly 14 pages are availabe for public view
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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’ 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’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.
Four types of records were collected; questionnaires, direct anthropometric measurements, standardized photos and videos and finally maxillary impressions. These records were used to evaluate the primary and secondary outcomes. Records where collected at T1 (before start of the NAM or taping treatment and questionnaires after 1 week of starting the treatment), T2 (before surgical lip repair at 3 months of age and after the end of the NAM and taping treatment) and T3 (2-3 weeks after the surgical lip repair).
from the results of the clinical and statistical analyses, and within the limitations of this study, the following conclusions could be withdrawn:
1. Parents of the UCLP infants were moderately capable of handling and accepting the NAM appliances and taping. Both, M-NAM and D-NAM got the same degree of acceptance by the parents. Parents were equally accepting the taping in the 3 intervention groups. No difference was detected in the general condition of the infants in the 4 groups at the 3 timepoints as evaluated by the parents.
2. Parents were totally unsatisfied with their infants’ appearance before starting any treatment at T1. A significant increase in their satisfaction occurred at T2 after the NAM appliance treatment and taping alone. The degree of satisfaction in the 2 NAM groups was higher than the taping and control groups at T2. For the control group, insignificant change in the degree of satisfaction between T1 and T2 was recorded.
3. After surgical lip repair at T3, the parents were equally satisfied with the esthetic results of their infants in the 4 groups.
4. Parents experienced a low to moderate amount of stress in the 4 groups. For the 3 intervention groups, the stress level remains constant along the 3 timepoints. The stress level of the parents in the control group decreased from T1 to T3, which might be due to the absence of any intervention.
5. Parents were highly supportive to their infants in the 4 groups and at the 3 timepoints. The level of support increased from T1 to T3 in the 3 intervention groups in comparison to control, in which it remained constant. At T3, the parents in the 3 intervention groups recorded a significantly higher support level than those of the control group. It seems that the presence of an intervention might increase the parental support level.
6. M-NAM and D-NAM were efficient appliances in improving nose and lip esthetics in comparison to control before surgical lip repair.
7. Taping alone can markedly improve nose and lip esthetics before surgical lip repair versus the untreated control.
8. Taping was equally efficient in improving the nose and lip esthetics to the 2 NAM appliances except in the clefted nostril height which was better in the NAM groups before surgical lip repair.
9. After surgical lip repair, non-statistically significant differences were detected in the nose and lip esthetics between the 3 intervention groups and the control group.
10. Based on the clinical results, increase the severity of the cleft might compromise the surgical outcome as shown in some cases in the control group.
11. The introduced M-NAM activation technique was significantly efficient in improving the maxillary arch dimensions and decreasing the cleft defect before surgical lip repair in comparison to the untreated control.
12. The D-NAM technique using virtual model modification, virtual appliance construction and 3D printing technologies was successful in improving the maxillary arch dimensions and decreasing the cleft defect before surgical lip repair in comparison to the untreated control.
13. D-NAM was more efficient than the M-NAM in improving the greater segment displacement and arch symmetry, in addition to the less incidence of intraoral ulcerations.
14. Taping alone was equally efficient to the 2 NAM appliances in improving the maxillary arch dimensions in comparison to controls before surgical lip repair.