OBJECTIVE: To three-dimensionally assess differences in craniomaxillofacial skeletal development in patients with operated unilateral cleft lip and palate (UCLP) treated with/without presurgical nasoalveolar molding (PNAM) with a mean age of 5 years.
METHODS: Cone-beam CT radiographs of 30 patients with UCLP who had undergone PNAM and 34 patients with UCLP who did not receive PNAM were analyzed. The data were stored in DICOM file format and were imported into the Dolphin Imaging program for 3D image reconstruction and landmark identification. 33 landmarks, 17 linear and three angular variables representing craniofacial morphology were analyzed and compared by using the Mann-Whitney U tests.
RESULTS: The vast majority of linear variables and 3D coordinates of landmark points reflecting craniofacial skeletal symmetry were not significantly different between the two groups. In terms of craniofacial skeletal development, the PNAM group had a significantly smaller anterior nasal spine offset in the midsagittal plane and a greater maxillary length compared to the non-PNAM group.
CONCLUSIONS: Evaluations performed in early childhood showed that treatment with/without PNAM in the neonatal period was not a major factor influencing craniomaxillofacial hard tissue development in patients with UCLP; moreover, PNAM treatment showed significant correction of skeletal deviation at the base of the nose.
CONCLUSIONS: Follow-up in early childhood has shown that PNAM treatment administered during the neonatal stage does not impede maxillary development and has benefits in correcting nasal floor deviation. It is a viable option for improving nasal deformity in children with unilateral cleft lip and palate.

OBJECTIVE: Evaluate facial changes after Presurgical Naso-Alveolar Molding (PNAM) in unilateral cleft lip and palate (UCLP) patients treated with Modified Grayson Technique and AlignerNAM (with DynaCleft nasal elevator) using a 3D facial scan.
METHODS: Randomised clinical trial.
METHODS: Institutional study. Participants: 20 UCLP patients allocated to two groups (10 patients each).
METHODS: Group A patients underwent PNAM with Modified Grayson Technique and Group B patients underwent AlignerNAM (with DynaCleft nasal elevator). Their 3D facial scans were obtained by using an iOSbased application (Bellus3D FaceApp) mounted on a novel frame. These .stl files were analysed using 3D software (GOM INSPECT) at three-time intervals; before intervention (T0), after intervention (T1) and one month after lip repair surgery (T2).
METHODS: Changes in facial and nasolabial morphology.
RESULTS: Both techniques brought significant improvement in the columellar length, nasal tip projection, columella angle, nasal tip angle and a significant reduction in cleft width. At T1, a statistically significant difference in angular and linear measurements was present in both groups. At T2, no statistically significant difference in linear parameters was observed between the two groups except for the outer lateral height of the non-cleft side, basal lateral height of the non-cleft side, and philtrum width. Similar pattern was observed in angular measurements with no statistically significant difference between the two groups except in nasolabial angle, anterior nasal base triangle III, and anterior nasal root triangle.
CONCLUSIONS: Aligner NAM and Modified Grayson technique are equally effective PNAM methods with similar clinical results in nasolabial morphology after lip repair surgery.

OBJECTIVE: This study aims to provide a comprehensive review and case study about the advantages and disadvantages of the application of digital technologies in presurgical orthopedics in newborns/infants with cleft lip and palate (CLCP). Positive changes in the nasal anatomy, maxillary arch, and cleft width could be achieved.
METHODS: Three representative cases of newborns/infants with CLCP were managed using the presurgical newborn/infant orthopedics (PSIO) approach. The patients were diagnosed and treated. Detailed descriptions of the impression procedures and PSIO appliance construction and placement were provided for each case.
RESULTS: Case 1 utilized traditional impression techniques, Case 2 employed a semi-digitalized approach with intraoral digital scanning, and Case 3 utilized a completely digitalized method for appliance construction. Positive changes in maxillary arch dimensions and cleft width reduction were observed in all cases.
CONCLUSIONS: The management of CLCP in newborns and infants poses a complex challenge with profound implications. The PSIO approach not only facilitates reconstructive surgery but also enhances overall quality of life. Digital tools, like specialized optical scanners and 3D printing, revolutionize the PSIO process, making it more efficient and patient-friendly. Clinical benefits include improved facial morphology, esthetics, feeding, speech, and optimized future surgical results. Despite ongoing efficacy debates, global adoption as the initial surgical approach underscores its value. The integration of digital technologies offers new hope for patients and families, promising a brighter future for those affected by this congenital condition.

The advantages of nasoalveolar molding (NAM) treatment for cleft lip and palate (CLP) patients have been well documented. A modified design for bilateral CLP was introduced.
This paper aimed to: 1- quantify the soft tissue changes after applying modified NAM treatment to these patients; and 2-compare post-surgical changes to a control group where no NAM was used.
At a tertiary care paediatric hospital, a historical cohort group of complete BCLP patients (n=15) was compared to a prospectively collected group of complete BCLP patients who underwent NAM therapy (n=15). In the NAM group (mean age: 1.1mos±0.2), a new modification of the NAM appliance was implemented. In the control group (mean age: 5mos±0.2), no NAM treatment was adopted prior to lip closure surgery. Soft tissue nasolabial segments were measured on initial (T1), post-NAM (T2) and 3 months post-surgery (T3) photographs; measurements were analysed statistically.
In the NAM group, cleft size was reduced by 68 to 70% in 4-5months and all measurements improved between T1 and T2. Columellar crest inclination decreased by 74%, columellar length increased by 184%, nostril and bialar widths decreased by 36% and 16%, respectively. The lip philtrum was elongated by 49.5%. At T3, all soft tissue variables statistically improved better in NAM versus non-NAM groups.
The modified NAM appliance provided improved results of lip approximation and nasal measurements compared to non-NAM treatment.

UNASSIGNED: A significant improvement in the nasal symmetry after presurgical nasoalveolar molding (PNAM) is seen in complete unilateral cleft lip and palate (UCLP) infants. However, the follow-up changes in the nasal symmetry before and after PNAM and surgical repair have not been well documented.
UNASSIGNED: The purpose of this retrospective study is to assess the progressive changes in the nasal symmetry after PNAM and primary cheiloplasty to 1 year in complete UCLP infants. Out of 28 complete UCLP patients who were given PNAM treatment during the period between January 2014 to March 2019, 19 UCLP infants could be included for the study. Submental oblique photographs at the initial visit (T1), immediately after cheiloplasty (T2), and 1 year (T3) after cheiloplasty were selected, and quantity of nasal asymmetry at each period (T1-T2; T1-T3; and T2-T3) was analyzed by paired t-test (P < 0.05).
UNASSIGNED: The quantity of asymmetry revealed that there was a highly significant improvement (P < 0.001) in nasal asymmetry at T1-T2 and T1-T3. Nonsignificant relapse was observed at T2-T3; however, a significant relapse in nasal dome height was observed during this period.
UNASSIGNED: The improvement in the nasal symmetry after cheiloplasty in PNAM-treated patients is maintained till 1 year postsurgically though there is a nonsignificant relapse.

Patients with cleft lip and palate (CLP) encounter various problems, including disorders related to feeding, esthetics, and pronunciation. We compared two impression methods, conventional impression making and intraoral scanning, to study unilateral cleft lip and palate (UCLP). Patients with UCLP (n = 7) were selected, and palatal impressions were taken by two steps: (1) impressions were obtained using an addition silicone rubber impression material, and a plaster model was prepared and (2) optical impressions were obtained using a desktop three-dimensional (3D) scanner and stereolithography (STL). Data were generated by two impression system combinations through STL. The results were analyzed using the Kruskal-Wallis or Mann-Whitney U test. There were no significant differences in the dimensions of the models between both groups. The measured depth of the alveolar cleft defects was deeper in the plaster model group (STL) than in the intraoral scanner group (STL). Digital models may prevent the risk of aspiration and respiratory disorders by using impression materials for preoperative jaw treatment of newborns and infants. We compared the results of both impression methods in the same patient and found that a shift to the 3D printer model is a safe alternative for preoperative jaw correction, as evidenced from the amount of tissue displaced due to the pressure applied during impression taking. In the future, we would like to conduct clinical research with a larger sample size of CLP patients to further corroborate these findings.

The aim of this retrospective long-term study was to assess the influence of primary columella lengthening and presurgical nasoalveolar molding (NAM) on the skeletal development at the completion of growth in patients with bilateral cleft lip and palate (BCLP). Lateral cephalometric radiographs at the completion of growth of consecutively treated patients BCLP patients, operated by the same surgeon, who had undergone NAM were compared with a second group of BCLP patients who were not treated with NAM. The groups were matched for sex and age. Independent samples t tests were carried out. 23 Lateral cephalometric radiographs of BCLP patients (mean age 18.2 ± 1.3 years) who had undergone NAM were compared with a second group of 23 BCLP patients (mean age 18.4 ± 1.3 years) who were not treated with NAM. The only two significant differences were observed in Ans-Me/N-Me (control group = 0.6 ± 0.02; sample group = 0.57 ± 0.05; p = 0.019) and ILs^AnsPns (control group = 105.5 ± 7.9; sample group = 112.4 ± 8.6; p = 0.007). No other significant differences were observed in terms of facial skeletal development between the two groups. Presurgical NAM performed during infancy in BCLP patients does not seem to have negative effects on the skeletal development at the completion of craniofacial growth compared to the group of patients treated without NAM.

The aim is to compare the facial esthetics following nasoalveolar molding (NAM) versus computer-aided design NAM (CAD/NAM) in patients with bilateral cleft lip/palate (CLP).
The trial is a randomized comparative trial with a 1:1 allocation ratio.
Thirty infants with bilateral complete cleft lip and palate were recruited.
Patients were randomized between NAM and CAD/NAM groups. The treatment steps described by Grayson were followed for the NAM group. In the CAD/NAM group, digitized maxillary models were made to create a series of modified virtual models, which were used to fabricate the molding plates using 3-dimensional printing technology. The nasal stents were then added to the intraoral plates following the Grayson method. The study lasted for 4 months.
The assessment of the changes observed in the interlabial gap and nasolabial esthetics was done using standardized 2-dimensional photographs. The correlation between dental arch changes and extraoral facial esthetics was studied.
Both modalities showed improvement in nasolabial esthetics before the lip surgery. No statistically significant difference was found between NAM and CAD/NAM groups in any of the assessed variables.
Both interventions were effective in the management of infants with bilateral CLP.

OBJECTIVE: To assess the influence of virtual reality (VR) in parent acceptance of the pre-surgical nasoalveolar molding (PNAM) as a pre surgical care to the cleft lip and palate affected infants.
METHODS: Descriptive Cross sectional pilot study design was planned to assess the pre surgical management of the cleft lip and palate. Twenty parents/caregivers of the infants were randomly divided into two groups. Twelve participants received education through conventional education module (Group I) using verbal explanation supported by the photographs. Another 12 participants received education through customized VR based educational video (Group II). After the education, the parents were provided with questionnaire to assess the acceptance of the treatment procedure. The survey response rate was represented in percentage.
RESULTS: The results of the study indicated that most of the parents were aware of the feeding plate or obturators as an aid in assisting feeding practices among cleft lip and palate affected infants. However, only 33% of participants in Group I were able to understand the doctor\'s explanation regarding the PNAM whereas 100% of participants in Group II were able to visualize the benefits of PNAM. These participants were willingly accepting PNAM as essential pre-surgical care.
CONCLUSIONS: Innovative approaches are essential in patient education modalities as the success of any treatment outcome largely depends on the patient acceptance. Within the limits of this study, VR has been successful in the educating the parents and caregivers regarding the acceptance of PNAM therapy in cleft affected infants.

OBJECTIVE: This paper describes the changes in maxillary arch morphology in infants with bilateral cleft lip and palate (BCLP) following nasoalveolar molding (NAM) and with follow up to assess the need for secondary alveolar bone grafting (ABG) and premaxillary repositioning surgery at preadolescence.
METHODS: Treatment records of infants with BCLP treated with NAM between 2003 and 2013 were reviewed. Patients with complete BCLP who underwent NAM and had complete sets of maxillary casts at T 0 pre-NAM (mean = 27 days), T 1 post-NAM (mean = 6 months and 5 days), and T 2 before palate surgery (mean = 11 months and 15 days) were included. The sample comprised 23 infants (18 male, 5 female). Casts were digitized and analyzed using three dimensional software. The need for secondary ABG and premaxillary repositioning surgery was assessed at preadolescent follow-up (mean = 8.3 years).
RESULTS: Cleft width was reduced on average by 4.73 mm (SD±3.15 mm) and 6.56 mm (SD±4.65) on the right and left sides, respectively. At T 1, 13 (56.52%) patients underwent bilateral gingivoperiosteoplasty (GPP), 8 (34.78%) patients unilateral GPP, and 2 patients (8.7%) did not undergo GPP. 34/46 clefts sites (73.91%) underwent GPP while 12 (26.08%) did not. At preadolescent follow-up of 19 patients, 7 patients (36.84%) did not need ABG on either side, 8 (42.10%) needed ABG on 1 side, and 4 (21.05%) needed ABG on both sides. None of the patients needed premaxillary repositioning surgery.
CONCLUSIONS: Nasoalveolar molding treatment significantly improves the position of the premaxilla before primary repair, and there is a significant reduction in the need for secondary ABG and premaxillary repositioning surgery at preadolescence.