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Abstract Background Cleft lip and palate (CLP) are among the most common congenital anomaly that affects up to 33,000 newborns in India every year. Nasoalveolar moulding (NAM) is a non-surgical treatment performed between 0 and 6 months of age to reduce the cleft and improve nasal aesthetics prior to lip surgery. The NAM treatment has been a controversial treatment option with 51% of the cleft teams in Europe, 37% of teams in the USA and 25 of cleft teams in India adopting this methodology. This treatment adds to the already existing high burden of care for these patients. Furthermore, the supporting evidence for this technique is limited with no high-quality long-term clinical trials available on the effectiveness of this treatment. Method The NAMUC study is an investigator-initiated, multi-centre, single-blinded randomized controlled trial with a parallel group design. The study will compare the effectiveness of NAM treatment provided prior to lip surgery against the no-treatment control group in 274 patients with non-syndromic unilateral complete cleft lip and palate. The primary endpoint of the trial is the nasolabial aesthetics measured using the Asher McDade index at 5 years of age. The secondary outcomes include dentofacial development, speech, hearing, cost-effectiveness, quality of life, patient perception, feeding and intangible benefits. Randomization will be carried out via central online system and stratified based on cleft width, birth weight and clinical trial site. Discussion We expect the results from this study on the effectiveness of treatment with NAM appliance in the long term along with the cost-effectiveness evaluation can eliminate the dilemma and differences in clinical care across the globe. Trial registration ClinicalTrials.gov CTRI/2022/11/047426 (Clinical Trials Registry India). Registered on 18 November 2022. The first patient was recruited on 11 December 2022. CTR India does not pick up on Google search with just the trial number. The following steps have to be carried out to pick up. How to search: ( https://ctri.nic.in/Clinicaltrials/advsearch.php —use the search boxes by entering the following details: Interventional trial > November 2022 > NAMUC).

Objective: The objective of this study is to measure the morphological changes of the nose and lip in patients with unilateral cleft lip and palate before and after cheiloplasty with primary rhinoplasty (primary correction) in conjunction with Korat‐NAM usage. Design: Longitudinal cohort study. Setting: Cleft Center Maharat Nakhon Ratchasima Hospital, Nakhon Ratchasima, Thailand. Subjects: Twenty‐six patients with unilateral cleft lip and palate. Interventions: Control group: only active obturator before primary correction. Experimental group: an active obturator and Korat‐NAM I before primary correction. A customized endotracheal tube was retained in the nostril for 3 weeks before switching to Korat‐NAM II for 1 year. Main Outcome Measures: Six measurements comprising nostril rim length, nostril height, nostril sill width, columella angle, vertical lip height, and horizontal lip length were measured from the patients' photographs. All measurements, except the columella angle, were reported as the cleft side/non‐cleft side value ratio. Measurements were taken at the initial appointment, immediately before, 3 weeks after, and 1 year after primary correction. Results: Nostril rim length ratio, nostril height ratio, nostril sill width ratio, columella angle on the cleft side, and vertical lip height ratio were improved using Korat‐NAM before and 3 weeks after primary correction. Nostril rim length and height ratios were significantly better than the control group. Conclusions: Korat‐NAM improved nose and lip morphology before primary correction. An overcorrection improved the nose and lip morphology on the cleft side. The nostril rim length and vertical lip height on the cleft side also improved with Korat‐NAM II 1 year after primary correction. [ABSTRACT FROM AUTHOR]

Background: Cleft lip and palate is the most common and unfortunate congenital defect that is debilitating for both the patients and their parents. Such complex condition demands for a precise and judicious management, as its outcome can drastically influence the quality of life of the child. Aim: To provide a concise treatment algorithm or tree which might guide the clinicians and make it easier for them to opt for a better treatment option when confronting different severities and types of this defect. Material and Methods: The clinical experience at our center alongwith review of current literature is used to propose a decision making treatment tree. Discussion: For the better aesthetics, function and ease of cosmetic surgery, several presurgical procedures have been introduced including the nasoalveolar moulding (NAM) appliance, adhesive tapes with nasal elevators, Figueroa's appliance, Hotz appliance, etc. Conclusion: The schematic decision-making tree may prove beneficial to the healthcare providers specially pedodontists who frequently come across such situations to choose the best treatment option for their patients. [ABSTRACT FROM AUTHOR]

This multicenter study aimed at comparing different techniques of lip and nose repair with or without NAM and primary anterior rhinoplasty in pre-adolescent children. Patients with unilateral clefts of lip, alveolus, and palate who had undergone cleft lip and nose repair were evaluated in a prospective three-centre study using standardized monochromatic, cropped photographs. Four cleft surgeons evaluated the aesthetics of the central part of the face when the patients had reached age ten years. Seventy-six sets of photographs out of 87 patients were evaluated. The overall ratings of lips and noses did not differ much between centres. However, noses of centres 1 (mean 0.74; SD 0.57) and 2 (mean 0.76; SD 0.60) had been rated better than centre 3 (mean 1.32; SD 0.78; p = 0.0078), especially "Deformation of upper part of nostril rim or poor position of alar cartilage". Centre 3 had produced better looking scars (mean 0.33; SD 0.48); p = 0.0036. Within the limitations of the study it seems that NAM and primary anterior rhinoplasty including postoperative nasal stents should be performed whenever possible in order to achieve a favorable shape of the nose and to reduce the need for secondary corrective surgery. [ABSTRACT FROM AUTHOR]

The aim of this systematic review was to compare the treatment outcomes of digital nasoalveolar moulding (dNAM) technique with conventional nasoalveolar moulding (cNAM) or non-presurgical intervention protocol in infants with unilateral (UCLP) or bilateral (BCLP) cleft lip and palate. A bibliometric search by MEDLINE (via Ovid), Embase, Cochrane Library, grey literature and manual method was conducted without language restriction until November 2023. Literature screening and data extraction were undertaken in Covidence. The risk of bias was evaluated using the Newcastle-Ottawa Scale and RoB-2. Pooled effect sizes were determined through random-effects statistical model using R-Software, and the certainty of evidence was assessed using the GRADE approach. Among 775 retrieved articles, nine studies were included for qualitative synthesis (6-UCLP, 3-BCLP), with only three eligible UCLP studies for meta-analysis. In the UCLP group, very low certainty of evidence indicated no difference in alveolar cleft width (SMD, 0.13 mm; 95% CI, -0.31 to 0.57; I 2 , 0%), soft tissue (lip) cleft gap, nasal width, nasal height, and columellar deviation angle changes between dNAM and cNAM. In the BCLP group, qualitative synthesis suggested similar changes in alveolar, lip, and nasal dimensions with dNAM and cNAM. In both cleft groups (UCLP, BCLP), reduced alveolar cleft width was observed in the dNAM group compared to the non-presurgical intervention protocol, along with fewer clinical visits and reduced chairside time for dNAM compared to cNAM. It can be concluded that the treatment outcomes with dNAM were comparable to cNAM in reducing malformation severity and were advantageous in terms of chairside time and clinical visit frequency. However, the overall quality of evidence is very low and standardization is needed for the virtual workflow regarding the alveolar movements and growth factor algorithms. Registration: PROSPERO-database (CRD42020186452)., (© 2024 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

This study investigated the efficiency of nasoalveolar moulding (NAM) in patients presenting with bilateral cleft lip and palate (BCLP). It focused explicitly on nasal outcome and therefore made comparisons with healthy age-matched infants with normal nasal development. Nasal impressions from 19 BCLP patients were analysed at the beginning and at the end of NAM treatment. In addition, nasal impressions from 32 healthy newborns were taken monthly for 4 months. The casts were digitalized and analysed, using defined anatomic landmarks, by two independent observers. Initial values were compared with outcome parameters at the end of NAM therapy and with the healthy cohort. NAM significantly elongated the columella in BCLP patients, with an increase of 106.5% versus 14.5% in healthy newborns. Nostril height showed significant expansion from 4.2 mm to 5.6 mm on the right side, and from 4.3 mm to 6.2 mm on the left side. NAM significantly elongated columella length and increased nostril height. The comparison with healthy newborns showed the effectiveness of early cartilage moulding. Detailed knowledge about absolute and relative early nasal growth was gained. However, despite highly effective NAM treatment in BCLP, nasal dimensions will not reach healthy proportions. [ABSTRACT FROM AUTHOR]

Abstract Nasoalveolar moulding is a presurgical orthopaedic technique used to improve the outcomes of bilateral clefts. However, the lack of a validated scale tailored to bilateral clefts makes it difficult to quantify the merits of nasoalveolar moulding and compare it to other techniques. In this study, a recently published anatomical subunit scale was used to evaluate and compare the early effects of nasoalveolar moulding. Two groups of similarly treated bilateral cleft patients were included: one in which patients underwent presurgical nasoalveolar moulding and one in which they did not. The nasolabial aesthetics were evaluated on two-dimensional photographs at 6 months post cheiloplasty. Cupid's bow, vermilion symmetry, vermilion notching, premaxillary show at rest, scar aesthetics, columella height, columella height, and bialar width were all significantly better in the nasoalveolar moulding group. Using the new scale, it was found that nasolabial aesthetics at 6 months post cheiloplasty were significantly better in patients who had undergone nasoalveolar moulding in infancy. [ABSTRACT FROM AUTHOR]

One of the most common congenital anomalies seen in the head and neck region are the orofacial clefts or clefting. Cleft lip and palate are one of the most common orofacial clefts around the globe. It impairs the speech, causes malocclusion, impaired suckling, facial deformity and has severe psychological impact. Treatment for these patients are crucial at the correct age and time with the help of multidisciplinary approach. This article provides an overview of the management in cleft lip and palate patients. [ABSTRACT FROM AUTHOR]

Rehabilitation of cleft lip and palate (CLP) patients is a challenge for all the concerned members of the cleft team, and various treatment modalities have been attempted to obtain aesthetic results. Presurgical infant orthopaedics (PSIO) was introduced to reshape alveolar and nasal segments prior to surgical repair of cleft lip. However, literature reports lot of controversy regarding the use of PSIO in patients with CLP. Evaluation of long-term results of PSIO can provide scientific evidence on the efficacy and usefulness of PSIO in CLP patients. The aim was to assess the scientific evidence on the efficiency of PSIO appliances in patients with CLP and to critically analyse the current status of PSIO. A PubMed search was performed using the terms PSIO, presurgical nasoalveolar moulding and its long-term results and related articles were selected for the review. The documented studies report no beneficial effect of PSIO on maxillary arch dimensions, facial aesthetics and in the subsequent development of dentition and occlusion in CLP patients. Nasal moulding seems to be more beneficial and effective in unilateral cleft lip and palate patients with better long-term results.

Aim The aim of this study was to explore the experience of parents caring for an infant with a cleft lip and palate receiving nasoalveolar moulding. Background Nasoalveoral moulding is a pre-surgical orthopedic appliance used to approximate an infant's cleft lip and palate, mould the nose and reduce surgical correction. Use of nasoalveolar moulding can be intensive, costly and lengthy requiring parental commitment to the process since it involves several months of weekly visits for appliance adjustment. Although extensive research has been conducted on surgical outcomes after use, little evidence exists pertaining to parental experiences caring for an infant undergoing the nasoalveolar moulding treatment process. Design The qualitative design phenomenology was used to best capture parents' lived experiences. Methods Eight mothers and four fathers participated in informal, semi-structured interviews during the months of April-May 2010. Results Four themes were identified: (1) You do what you have to do; (2) We weren't left alone in the dark; (3) It's just amazing to see the difference; and (4) It's like nothing ever happened. Findings indicated that despite some difficulties, parents' were dedicated to the treatment process and expressed the benefits exceeded any additional work nasoalveolar moulding required. Conclusion Multiple recommendations to assist parents with the nasoalveolar moulding treatment process were identified. Improving nasoalveolar moulding education and providing support can substantially improve challenges that are experienced by parents throughout this process - strengthening the importance of their role for successful nasoalveolar moulding outcomes. [ABSTRACT FROM AUTHOR]

Presurgical infant orthopedics has been employed since 1950 as an adjunctive neonatal therapy for the correction of cleft lip and palate. Most of these therapies did not address deformity of the nasal cartilage in unilateral and bilateral cleft lip and palate as well as the deficiency of the columella tissue in infants with bilateral cleft. The nasolaveolar molding (NAM) technique a new approach to presurgical infant orthopedics developed by Grayson reduces the severity of the initial cleft alveolar and nasal deformity. This enables the surgeon and the patient to enjoy the benefits associated with repair of a cleft deformity that is minimal in severity. This paper will discuss the appliance design, clinical management and biomechanical principles of nasolaveolar molding therapy. Long term studies on NAM therapy indicate better lip and nasal form, reduced oronasal fistula and labial deformities, 60 % reduction in the need for secondary alveolar bone grafting. No effect on growth of midface in sagittal and vertical plane has been recorded up to the age of 18 yrs. With proper training and clinical skills NAM has demonstrated tremendous benefit to the cleft patients as well as to the surgeon performing the repair.

To compare the three-dimensional changes occurring in the maxillary arch during the use of modified pre-surgical nasoalveolar moulding ( PNAM) and Hotz′s plate. A clinical trial including 32 children with unilateral cleft lip and palate ( UCLP), 16 treated with Hotz′s plate and 16 with PNAM, was performed. Impressions of the maxillary arches were taken: A. prior to pre-surgical orthopaedics, B. before cheiloplasty and C. after cheiloplasty. Models were digitised using a stereophotogrammetric instrument, and geodesic distances were calculated: anterior, canine and posterior widths of the arch, and lengths and cleft depths of the larger and shorter segments. The time and treatment effects were assessed by two-factor anova. A significant effect of treatment was found for cleft depth at the larger segment: children treated with Hotz′s plate had significantly deeper cleft than children treated with PNAM. All distances significantly changed during time: the anterior and canine widths decreased, while the posterior width, the lengths and depths of the cleft segments increased. Significant treatment per time interactions was found. The anterior and canine widths reduced more with PNAM between time points A and B while Hotz's treatment was more effective between B and C. The shorter segment depth increased more between B and C with PNAM, and between A and B with Hotz's plate. During pre-surgical orthopaedics, therapy with PNAM obtained the best results in reducing the width at the anterior segment of the cleft. This treatment gave a lower increase in cleft depth than treatment with Hotz′s plate. [ABSTRACT FROM AUTHOR]

We compared two methods of planning virtual alveolar moulding as the first step in nasoalveolar moulding to provide the basis for an automated process to fabricate nasoalveolar moulding appliances by using computer-assisted design and computer-aided manufacturing (CAD/CAM). First, the initial intraoral casts taken from seven newborn babies with complete unilateral cleft lip and palate were digitised. This was repeated for the target models after conventional nasoalveolar moulding had been completed. The initial digital model for each patient was then virtually modified by two different modelling techniques to achieve the corresponding target model: parametric and freeform modelling with the software Geomagic ® . The digitally-remodelled casts were quantitatively compared with the actual target model for each patient, and the comparison between the two modified models and the target model showed that freeform modelling of the initial cast was successful (mean (SD) deviation n = 7, +0.723 (0.148) to −0.694 (0.157) mm) but needed continuous orientation and was difficult to automate. The results from the parametric modelling (mean (SD) deviation, n = 7, +1.168 (0.185) to −1.067 (0.221) mm) were not as good as those from freeform modelling. During parametric modelling, we found some irregularities on the surface, and transverse growth of the maxilla was not accounted for. However, this method seems to be the right one as far as automation is concerned. In addition, an external algorithm must be implemented because the function of the commercial software is limited. [ABSTRACT FROM AUTHOR]

Rehabilitation of cleft lip and palate (CLP) patients is a challenge for all the concerned members of the cleft team, and various treatment modalities have been attempted to obtain aesthetic results. Presurgical infant orthopaedics (PSIO) was introduced to reshape alveolar and nasal segments prior to surgical repair of cleft lip. However, literature reports lot of controversy regarding the use of PSIO in patients with CLP. Evaluation of long-term results of PSIO can provide scientific evidence on the efficacy and usefulness of PSIO in CLP patients. The aim was to assess the scientific evidence on the efficiency of PSIO appliances in patients with CLP and to critically analyse the current status of PSIO. A PubMed search was performed using the terms PSIO, presurgical nasoalveolar moulding and its long-term results and related articles were selected for the review. The documented studies report no beneficial effect of PSIO on maxillary arch dimensions, facial aesthetics and in the subsequent development of dentition and occlusion in CLP patients. Nasal moulding seems to be more beneficial and effective in unilateral cleft lip and palate patients with better long-term results. [ABSTRACT FROM AUTHOR]

Introduction: Cleft lip and palate represents the most frequently occurring congenital deformity second only to club foot deformity in our country. Wide alveolar clefts if not preceded by pre surgical orthodontic adjuncts like nasoalveolar moulding, may affect the final outcome of the primary surgery. Presurgical nasoalveolar moulding is to align and approximate the alveolar cleft segments while at the same time achieving correction of the nasal cartilage and soft tissue deformity. Materials and methods: The device we used is designed by Barry Grayson. It is simple to fabricate, causes less discomfort to the patient and optimum results are achieved in three months of time, compared to other complicated appliances like Latham's which are more invasive. A child of 3 months presented with a complaint of unilateral cleft deformity on one side of the face. Conclusion: After three months of nasoalveolar moulding considerable changes were observed. The widths of the cleft alveolus were reduced and the nasal contours of columella on the cleft side showed considerable improvement. [ABSTRACT FROM AUTHOR]

Abstract: We describe our experience with various silicone materials for making one-step and two-step impressions of the cleft-lip-palate-nose complex during nasoalveolar moulding. Our technique is superior to common alginate-based impression techniques, as it provides precise reproduction of the complex anatomy of the cleft, and is compatible with the latest available methods of planning treatment with nasoalveolar moulding, such as computer-aided reverse engineering and rapid prototyping. [Copyright &y& Elsevier]

Presurgical infant orthopedics has been employed since 1950 as an adjunctive neonatal therapy for the correction of cleft lip and palate. Most of these therapies did not address deformity of the nasal cartilage in unilateral and bilateral cleft lip and palate as well as the deficiency of the columella tissue in infants with bilateral cleft. The nasolaveolar molding (NAM) technique a new approach to presurgical infant orthopedics developed by Grayson reduces the severity of the initial cleft alveolar and nasal deformity. This enables the surgeon and the patient to enjoy the benefits associated with repair of a cleft deformity that is minimal in severity. This paper will discuss the appliance design, clinical management and biomechanical principles of nasolaveolar molding therapy. Long term studies on NAM therapy indicate better lip and nasal form, reduced oronasal fistula and labial deformities, 60 % reduction in the need for secondary alveolar bone grafting. No effect on growth of midface in sagittal and vertical plane has been recorded up to the age of 18 yrs. With proper training and clinical skills NAM has demonstrated tremendous benefit to the cleft patients as well as to the surgeon performing the repair.

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Abstract: The objectives of this study were to: evaluate the effects of nasoalveolar moulding (NAM) in complete unilateral cleft lip and palate infants presenting for treatment at different ages; propose a new NAM protocol in these patients; improve the predictability of NAM. Study groups comprised: group I (n =15) treated with NAM within 1 month of age; group II (n =15) treated with NAM between 1 and 5 months of age. Control: group III (n =15) comprised of non-cleft 18-month old children. A standard protocol was followed. Patients were evaluated before initiation of NAM, before cheiloplasty and at 18 months. 7 linear anthropometric measurements were compared using dento-facial models. Statistical analysis before and after NAM revealed that group I patients demonstrated 81%, 198%, 69% and 145% improvement in intersegment distance, nasal height, nasal dome height and columella height respectively; whilst group II patients demonstrated 51%, 33%, 21% and 38% improvement for the same. At 18 months, group I patients closely resembled group III patients. This study concluded that the effects of NAM were most significant in group I. Group II patients also benefited from NAM, although to a lesser extent. This study validates the use of NAM in infants presenting late for treatment. [Copyright &y& Elsevier]

Abstract: Over the last three decades bilateral cleft lip and nose repair has been characterised by a trend towards more detailed reconstruction of the nasolabial muscles together with simultaneous correction of the deformity. An understanding of the true nature of the nasal deformity in bilateral cleft lip and palate (BCLP) has gradually emerged, and has inspired new approaches to their repair. This article discusses recent trends and controversies in primary cheilorhinoplasty for BCLP. [Copyright &y& Elsevier]

Presurgical infant orthopedics has been a choice of treatment since 1950 as an adjunctive neonatal therapy for the management of cleft lip and palate. Most of the early techniques in cleft literature did not focus on the deformity of the nasal cartilage in unilateral and bilateral cleft lip and palate as well as the deficiency of the columella. The nasolaveolar moulding (NAM) technique is a modern approach developed by Grayson and Matsuo which reduces the severity of the initial cleft alveolar and nasal deformity. This paper will discuss the appliance fabrication, design, insertion, taping and clinical management of nasolaveolar moulding therapy. NAM therapy has a lot of advantages in achieving better lip and nasal form, reduced labial deformities thus enables the surgeon to get a better result in the primary repair of cleft alveolus, lip and nose. [ABSTRACT FROM AUTHOR]