Nasolabial morphological changes in patients with unilateral cleft lip and palate using a Korat-modified nasoalveolar moulding appliance with primary correction.

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.

Treatment outcomes of digital nasoalveolar moulding in infants with cleft lip and palate: A systematic review with meta-analysis.

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; I2, 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).

Effects of pre-surgical nasoalveolar moulding on maxillary arch and nasal form in unilateral cleft lip and palate before lip surgery.

OBJECTIVES: To investigate the effects of pre-surgical nasoalveolar moulding (PNAM) on the maxillary arch and nasal form in patients with unilateral cleft lip and palate (UCLP). SETTING AND SAMPLE POPULATION: This is a retrospective case series study. The subjects were infants with complete UCLP who were treated with PNAM (n = 18) at Kagoshima University Medical and Dental Hospital (Japan) between 2006 and 2013. MATERIAL AND METHODS: Maxillary dental casts and facial photographs were taken at the time of the first visit and immediately prior to lip surgery to evaluate the maxillary arch and nasal form changes. The dental casts were scanned with a laser scanner, and changes in the 3-Dimensional coordinates of anatomical landmarks and alveolar cleft width were analysed. Moreover, we investigated the correlation between the changes in the maxillary alveolar arch and nasal form. RESULTS: Regarding the maxillary alveolar arch form, the anterior points of the major segment had moved significantly to the cleft side just prior to the time of lip repair, and the alveolar cleft width was significantly decreased. For nasal form, the inclination and displacement of the columella were significantly improved. The improvement of columella inclination was moderately correlated with the posterior movement of the anterior points of the major segment. CONCLUSIONS: These findings indicate that PNAM for infants with UCLP enhanced symmetry in the maxillary alveolar arch and nasolabial form. In addition, the posterior movement of the anterior points of the maxillary alveolar arch was correlated with the improvement of columella deformation.

Parental experience caring for cleft lip and palate infants with nasoalveolar moulding.

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.

3D evaluation of maxillary arches in unilateral cleft lip and palate patients treated with nasoalveolar moulding vs. Hotz's plate.

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.

Presurgical nasoalveolar moulding in unilateral cleft lip and palate.

CONTEXT: Presurgical nasoalveolar moulding (PNAM) is a non-surgical method of reshaping the cleft lip, alveolus, palate and the nose to minimize the severity of the cleft deformity, before primary cheiloplastyand palatoplasty. In this context, PNAM proves to be an invaluable asset in the management of unilateral cleft lip and palate. AIMS: The study was conducted to evaluate the efficacy of PNAM in the management of unilateral cleft lip and palate with the following objectives: (1) To assess and compare the degree of reduction in the size of cleft palate and alveolus (pre-PNAM and post-PNAM). (2) To evaluate and compare the improvement in columellar length and correction of columellar deviation (pre-PNAM and post-PNAM). (3) To assess the changes in the position of the alar base and the alar cartilages. SETTINGS AND DESIGN: Prospective study. SUBJECTS AND METHODS: A prospective study consisting of, which included 20 patients with complete unilateral cleft lip and palate was conducted. The age at the start of PNAM treatment of the infants ranged from 2 to 44 days of age reporting to our institute between December 2011 and August 2013. All the patients underwent PNAM therapy before primary cheiloplasty at 6 months of age; clinical parameters were assessed pre- and post-therapy using photographs and dental study models of the maxilla. STATISTICAL ANALYSIS USED: Student's t-test for paired comparisons. RESULTS: Results of the study showed a promising reduction in the cleft size before the surgery, significant improvement in nasal symmetry, including the columellar length on the cleft side. CONCLUSIONS: PNAM is a valuable adjunct to our surgical armamentarium in dealing with the challenges of primary closure of unilateral cleft lip and palate thereby enhancing the overall surgical outcome. The advantages of this method include the simplicity of the procedure and improving the quality of surgical repair, particularly in obtaining tension free muscle closure in unilateral clefts.

Current status of presurgical infant orthopaedic treatment for cleft lip and palate patients: A critical review.

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.

A multi-centric, single-blinded, randomized, parallel-group study to evaluate the effectiveness of nasoalveolar moulding treatment in non-syndromic patients with complete unilateral cleft lip, alveolus and palate (NAMUC study): a study protocol for a randomized controlled trial.

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).

Pre-surgical Nasal Molding of a Two-Day-Old Neonate With Complete Unilateral Cleft Lip and Palate Using Passive Nasoalveolar Molding Technique: A Case Report.

The occurrence of congenital deformities like cleft lip and palate is not uncommon and is often a traumatizing experience for families. The entire rehabilitation process includes frequent hospital visits and the brunt of numerous procedures. Early intervention with pre-surgical infant orthopedics facilitates better surgical outcomes and additional psychosocial benefits to the infant's family. The present clinical report addresses the pre-surgical management of a non-syndromic two-day-old female baby whose parents presented with the chief complaint of deformed lips, nose, and difficulty while feeding. The neonate had a complete left-sided cleft lip, alveolus, and cleft palate on examination. Early management with pre-surgical passive nasoalveolar molding (PNAM) has favorable outcomes, including desired upper lip, alveolus, and nose shape. Non-invasive pre-surgical intervention with PNAM reduces the severity of the deformities before the primary surgical repair, thus decreasing the overall cost of cleft care and the number of secondary revisions, thus increasing the probability of favorable outcomes.

Schematic Treatment Tree for the Presurgical Nasoalveolar Moulding of Patients with Cleft Lip and Palate.

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.

Lips and noses in 10-year old patients with repaired complete unilateral clefts of lip, alveolus, and palate. A prospective three-centre study of the Baltic Cleft Network.

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.

The absolute and relative effects of presurgical nasoalveolar moulding in bilateral cleft lip and palate patients compared with nasal growth in healthy newborns.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Orthopaedic traction with passive nasoalveolar moulding in a bilateral cleft lip and palate patient - Rediscovering the old.

INTRODUCTION: A 22-day-old male infant presented with complete bilateral cleft lip and palate with prominent premaxillary segment, wide alar base, flat alar domes and no columellar tissue, thus leading to a severe facial deformity. A presurgical nasoalveolar moulding (PNAM) procedure was planned to facilitate an optimal surgical approximation of the cleft and surrounding tissues. METHODS: PNAM was performed on the basis of the hypothesis that 'The palatal shelves continue to grow unabated if adequate relief is provided by wax mock up while preparing the feeding plate'. An intraoral device, which consisted of an acrylic feeding plate, was constructed after adequate wax mock up in the cleft area for passive moulding, along with extraoral traction force through active lip taping. A nasal stent was subsequently attached to lift the nasal domes and lengthen the columella. The changes thus achieved with PNAM were assessed using innovative photographic and model analyses. RESULTS: On completion of PNAM, the qualitative photographic changes showed significant premaxillary setback, columellar lengthening and fullness of alar domes. The quantitative model analysis revealed reduction in the anteroposterior cleft gap by 5 mm and 5.5 mm on right and left sides, respectively. Transverse distance between the two palatal segments reduced by 3.5 mm, 8 mm and 8.5 mm in anterior, middle and posterior regions, respectively. CONCLUSION: Orthodontic intervention performed for 11 weeks by PNAM helped to retract the premaxilla, reduce the cleft gap, improve the arch form, approximate lip segments and distinctly lengthen the columella. Hence, it improved the morphology of the nose by correcting the flattened nasal wings. This aided the surgeon to achieve an optimal surgical repair.

An assessment and comparison of nasolabial aesthetics in bilateral clefts using the anatomical subunit-based scale: a nasoalveolar moulding versus non-nasoalveolar moulding study.

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.

Analysis of computer-aided techniques for virtual planning in nasoalveolar moulding.

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.

Nasoalveolar moulding for children with unilateral cleft lip and palate.

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.

Impression technique for monitoring and virtual treatment planning in nasoalveolar moulding.

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.