Nasoalveolar Molding Research Articles

Perception, attitude, and opinion of parents of cleft lip and palate patients treated with nasoalveolar molding (NAM): A cross-sectional questionnaire study.

The main goal of the nasoalveolar molding (NAM) is to mitigate the initial severity of the cleft, facilitating the subsequent surgical procedures. Nevertheless, the use of the appliance entails high stress levels for families. The aim of this study was to assess the perceptions, attitudes, and opinions of parents whose cleft-affected children underwent treatment using the NAM technique. A cross-sectional questionnaire study was conducted on a cohort of relatives of infants born with cleft lip and palate who were treated with the NAM appliance. The parents completed a 59-item questionnaire that had been previously validated. The initial cohort consisted of 104 families. The level of satisfaction was high, and there was a direct correlation with early diagnosis. Satisfaction levels varied depending on the cleft type, with a decrease in cases of bilateral presentation. Satisfaction was influenced by the newborns' adaptation and the absence of complications. Parents who exhibited lower levels of satisfaction contemplated terminating the treatment. Parents expressed high satisfaction with NAM treatment, due to effective management and understanding. Bilateral clefts and delayed diagnosis can significantly impact satisfaction. These results emphasize the importance of personalized approaches to address challenges in NAM treatment, particularly in instances of bilateral clefts and delayed diagnoses.

The Efficacy of Naso-Alveolar Molding on Premaxilla Pushback and Dentoalveolar Changes in Patients With Bilateral Cleft Lip and Palate.

To evaluate the extent of naso-alveolar molding (NAM) in pushing the premaxilla posteriorly in patients with bilateral cleft lip and palate (BCLP). Naso-alveolar molding application in cleft lip and palate cases bridges the cleft gap and increases nasal tip projection. In BCLP, NAM potentially mobilizes the premaxilla posteriorly to allow tension-free primary lip closure. However, some patients with BCLP with NAM history still necessitate osteotomy during labioplasty, questioning the efficacy of NAM for BCLP management. This single-center retrospective study was conducted using medical records of nonsyndromic patients with BCLP. Twenty-six patients with BCLP were enrolled over a 5-year period with a history of NAM application before primary labioplasty. The changes in premaxilla width (P), anterior arch width (A), posterior arch width (R), and anteroposterior projection of the premaxilla (P'-A') were statistically analyzed at 2 time points: (1) at the start of NAM application (T1) and (2) after completion of NAM before surgery (T2). The average age at NAM initiation was 46.2 ± 40.4 days, and the average duration of NAM usage was 125.14 ± 62.94 days. A and P-A showed significant differences between T1 and T2 (P < 0.0001), whereas the rest did not show significant differences in value following NAM application (P > 0.05). Naso-alveolar molding successfully pushed back the premaxilla portion about 4.68 ± 2.83mm on average. Naso-alveolar molding can push back the premaxillary protrusion up to 5mm, which can serve as a cutoff point for the consideration of combined modalities. Prenatal diagnosis, counseling, and cleft education should be the benchmark in cleft centers to improve overall patient outcomes.

Nasoalveolar Molding in Lately Presented Moderate to Severe Unilateral Cleft Lip and Palate Infants: Does it Add?

Alignment of the alveolar segments with early nasal cartilage tackling is the foundation upon which excellent surgical results are dependent. The purpose is to evaluate the short-term effect of triple combination of passive alveolar molding with early nasal molding augmented by controlled corrective power of lip tapping in lately presented moderate to severe unilateral complete cleft lip and palate infants. A prospective case series study was conducted in Plastic and Maxillofacial Surgery Department, Ain Shams University in collaboration with Orthodontics Department, from January 2021 till June 2023, 15 infants elder than 2 months till 6 months were enrolled in the study. Eight nasal anthropometric measurements ratios through 2-dimension assessment and 4 maxillary arch measurements ratios through 3-dimension assessment were recorded. Extraoral results revealed clinically and statistically decrease of nasal width, alar base width, alar base height ratios, and columellar angle, while increase of nasal height, nasal dome height, columellar length, and alar projection length ratios. Intraoral results revealed clinically and statistically decrease in cleft width with maintained posterior arch width and intercanine width. In conclusion, this triple combination helped in presurgical lessening the alveolar and nasal deformity of such elder infants in a shorter time in comparison with other conventional methods with lesser number of appointments decreasing burden of care to their families improving their compliance.

Three-Dimensional Changes of Alveolar Ridges and Nasolabial Structures Following a Digital Nasoalveolar Molding Therapy With a Novel Nasal Stent Activation Protocol

Digital orthodontics has been integrated into NasoAlveolar Molding (NAM) therapy to overcome challenges in the conventional NAM method. This study introduced an individualized Digital NAM (iDNAM) and evaluated the changes in the alveolar ridges and nasolabial morphology after iDNAM treatment. Prospective data were collected from 15 infants with complete unilateral cleft lip and palate who underwent iDNAM therapy. An intraoral-and-nasolabial scan was used to create a virtual setup model and plate generation. A total of 2 plates were required under the iDNAM treatment protocol. The first iDNAM plate has a specific interior and exterior design to allow continuous force application with minimal plate adjustment. After an intermediate scan, a nasal stent was meticulously incorporated into the second plate for nasal molding. To activate the nasal stent, a silicone molding extension was used instead of manually adding acrylic. The alveolar cleft gap was significantly reduced by 7.48 ± 2.06 mm. On the cleft side, statistically significant increases occurred in nostril height, columellar length, and nasal base–columellar angle (2.08 ± 0.63 mm, 2.58 ± 0.28 mm, and 22.29 ± 0.88 degrees, respectively). By using 2 serial plates, iDNAM improved the alveolar cleft gap and the nasal morphology in complete unilateral cleft lip and palate. An addition of a nasal extension to the second iDNAM plate presents a challenge as accurate positioning is required for appropriate activation force. The iDNAM plate design and nasal activation protocol reduce the need for chairside adjustment and the number of appointments.

A Bibliometric Analysis of 100 Top-cited Articles on Cleft Orthodontics.

This bibliometric study seeks to provide a comprehensive overview of the 100 most frequently cited articles in the domain of cleft orthodontics. The analysis will reveal key influential publications, collaborative author networks, and identify prevailing research themes within the field. The studies related to Orthodontics in the realm of cleft lip and palate (CLP) were retrieved from the Scopus database on 30th August 2024 using key terms. The results obtained were sorted in descending order of citations and the 100 top-cited articles were hand-filtered. RStudio software version 4.2.0 and Bibliometrix R-package was used for performing scientometrics involving co-citation, co-occurrence, collaboration and co-word analyses, bibliographic coupling and network mapping. A total of n = 3984 articles were retrieved from which top-100 cited articles were filtered. These documents were published during 1950-2019 with peak production in 1997. The United States and the Netherlands were the most prolific countries involved in the given research. The majority of the highly referenced articles pertained to alveolar bone grafting, and treatment outcomes being the second common focus followed by Infant and early orthopedics (Naso-alveolar moulding, Maxillary Protraction) and facial growth during the given period. Thematic mapping depicted bone grafting, alveoloplasty (infant orthopedics) and maxillofacial development as the more developed core topics than the psychology and self-perception of patients with CLP. Recent research trends have shifted towards three-dimensional assessment methods.

Three-dimensional Analysis of Presurgical Nasoalveolar Molding Outcomes in Patients with Unilateral Cleft Lip and Palate: A Preliminary Study Using LED Surface Scanning Technology.

ObjectivesPresurgical infant orthopedic appliances, such as presurgical nasoalveolar molding (PNAM) devices, are used to attain optimal conditions for primary repair of the lip and nose (PRoLN) in patients with cleft lip. We aimed to analyze the three-dimensional (3D) outcomes of PNAM using an LED surface scanner. MethodsFifteen patients with unilateral cleft lip and palate (CLP) were included in this study and treated using a PNAM device. The patients’ faces were digitized pre- and post-PNAM using an Artec Space Spider scanner, and the scanned data were analyzed using 3D software (Geomagic Control X and ANSYS SpaceClaim). The columellar angle (CA), nostril curvature (NC) on the affected (NC_A) and unaffected (NC_U) sides, gap of cleft lip (GCL), alar width (AW), and nasal tip angle (NTA) were measured. ResultsCA increased significantly by 10.00° and NC_A by 0.030 mm-1 (p<0.001). GCL decreased by 4.98 mm2 on average and NC_U by 0.015 mm-1 (p=0.029 and 0.046, respectively). AW also decreased by approximately 1.22 mm pre- and post-treatment (p=0.002), and NTA, which shows a lateral profile, decreased by approximately 3.32° (p=0.002). ConclusionsThis study confirmed the orthopedic benefits of PNAMd treatment through 3D analysis using an LED surface scanner. Further studies involving a larger number of participants are warranted to study the effects of PNAM and analyze longitudinal changes in patients with CLP. Clinical SignificanceThis study shows that PNAM effectively corrects columellar deviation and nostril shape in patients with unilateral cleft lip, with 3D scanners enhancing primary lip and nose repair outcomes.

A Comprehensive Review of Nasoalveolar Molding: From Origins to Future Advances

Globally, the most prevalent birth malformations is cleft palate and cleft lip, etiology of cleft is multifactorial and occurrence is as a result of inaccurate tissue fusion. The treatment objective in these patients include restoration of normal anatomy to obtain desired skeletal, cartilaginous and soft tissue relationship. To minimize the severity of cleft before surgery of cleft lip and palate, a nonsurgical methods such as Nasoalveolar molding (NAM) can be used to reshape and align the lip, nostrils, and gingiva. There are various techniques available for Nasoalveolar molding which will be summarized in this article.

TeleCleft: Development and Evaluation of a Mobile Application for Monitoring Cleft Patients.

Development and evaluation of a mobile application for remote monitoring and guidance of pediatric patients diagnosed with cleft lip and/or palate (CL ± P) and their caregivers. This is a pilot cross-sectional, applied, and quantitative study. The study was conducted in two tertiary care treatment centers in Brazil. The participants included 20 caregivers and infants undergoing treatment with nasoalveolar molding (NAM) for CL ± P. The intervention involved using the TeleCleft mobile application for remote monitoring and guidance of caregivers and infants during NAM treatment. The main outcome measures included usability and satisfaction of users with the TeleCleft application. The results showed high usability and satisfaction ratings among users of the TeleCleft application. Most participants found remote monitoring to be effective and expressed positive opinions about its convenience and usefulness. TeleCleft could be a viable tool for remote monitoring and guidance, reducing the need for patients and caregivers to travel to treatment centers, which could potentially alleviate the burden of care faced by families during the journey of CL ± P treatment.

Using an Active Screwed Nasoalveolar Molding Device for Defect Rehabilitation in Patients With Bilateral Cleft Lip and Palate.

The present case series aimed to assess non-surgical elongation of the columella and reduction of cleft gaps in patients with bilateral cleft lip and palate using the active nasoalveolar molding (ANAM) device and tissue expansion principles. Thestudy included six complete bilateral cleft patients aged one month: three males and three females. A nasoalveolar molding technique was applied using an active device (ANAM) with a 3D screw, worn by infants for two months. The activation protocol for screw closure is approximately 0.25 mm (quarter turn) on alternating days, resulting in almost 1 mm per week and 4 mm per month and reaching 8 mm after eight weeks. Evaluation involved measuring lip defect sizes and the nostril gap, columellar lengthand rotation of premaxilla before and two months after the ANAM period before surgical repair. The results show that the anterior rotation of the premaxilla and the lip and nostril gaps were significantly reduced (p<0.05), with maximum reduction in the anterior rotation of the premaxilla (mean difference ±SD was 4.22±0.4). Simultaneously, the columellar height was significantly increased with a mean difference±SD of 2.0±0.4 (p<0.001). The current case series demonstrated that the ANAM device is a safe and effective technique for decreasing the lip and nostril gaps, repositioning the protruded premaxilla, and elevating the depressed columella. No side effects were recorded in current cases.

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

BackgroundCleft 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.MethodThe 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.DiscussionWe 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 registrationClinicalTrials.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).

Knowledge and awareness of pediatricians about early interventions performed by pediatric dentists in the management of cleft lip and palate – A questionnaire-based study

ABSTRACT Background and Introduction: Cleft lip and palate (CL/P) is one of the most common congenital anomalies which require multidisciplinary care. Patients with CL/P require appropriate corrective treatment to improve health, function, and esthetics. Knowledge about the various treatment procedures available and the timing of the procedures among pediatricians is vital for them to refer the patient at the correct stage to the appropriate specialist for the best possible rehabilitation. Aim: The aim of this study was to evaluate the knowledge and awareness of pediatricians about early interventions performed by pediatric dentists in the management of CL/P. Materials and Methods: A closed-ended questionnaire that included questions regarding the knowledge and awareness of obturators, lip taping, and nasoalveolar moldings was formulated. A questionnaire with 20 questions was circulated among the pediatricians through a web-based portal. Their knowledge and awareness about early interventions performed by pediatric dentists in the management of CL/P were assessed. Results: Results showed that out of 323 pediatricians who participated in the survey, 99.4% had heard of obturators. Awareness about lip taping was 78.3% while that of nasoalveolar molding was 55.1%. The benefits of the procedure and appliance were not well known. Conclusion: To improve the health, psychological, and social support of patients with CL/P, more awareness needs to be created among pediatricians regarding the management to provide better and timely oral rehabilitation.

Individualized Digital Nasoalveolar Molding: A Proof of Concept.

Nasoalveolar molding (NAM) is a recognized adjunctive therapy to primary cheiloplasty in patients with complete cleft lip and palate (CLP). The conventional technique can be time-consuming, costly, and requires experienced clinicians. Over the past decade, CAD/CAM technology has been employed to facilitate NAM therapy, showing promising results. This study introduces an individualized Digital NAM (iDNAM), a digital approach revolutionizing NAM treatment using CAD/CAM technology, and evaluates treatment outcomes. A 57-day-old infant with complete UCLP underwent intraoral and nasolabial scans, along with 3D photogrammetry. Open-source software was utilized for virtual alveolar segmentation and NAM plate design. iDNAM incorporates a nasal molding extension, introducing an innovative nasal stent activation protocol. Changes in alveolar and nasal morphology were compared between the initial and presurgery stages. After treatment with iDNAM, the alveolar cleft gap was reduced to 4.22mm. Nostril height on the cleft side, columellar length, and nose projection increased by 0.98, 2.40, and 1.90mm, respectively. The nasal base-columellar angle improved by 29.50 degrees. The results demonstrate a significant reduction in the alveolar cleft gap and improved nasal morphology, making iDNAM as an alternative to NAM therapy.

Alteration in maxillary arch dimensions following preoperative nasoalveolar moulding therapy in bilateral cleft lip and palate patients

ABSTRACT Purpose Bilateral cleft lip and palate (BCLP) are severe congenital anomalies. The cleft interferes with the normal growth of the maxilla, leading to deficient midfacial development. The aim of the present study was to evaluate the short-term influence of preoperative nasoalveolar moulding (NAM) therapy on maxillary arch dimensions in patients with BLCP. Materials and methods 18 newborns (male: 12; female: 6) were recruited who underwent NAM therapy before cheiloplasty. The pre- (T0) and post-NAM (T1) plaster casts of the maxilla were scanned using a laboratory scanner. The measured parameters on the digital casts included premaxilla width, right and left alveolar cleft width, right and left molar region length, anterior interalveolar-, intercanine-, intermolar-, intertuberosity width, palatal length and anterior basal angle. Results Both left (p = 0.047) and right (p = 0.019) alveolar clefts significantly reduced in size at T1. A significant expansion in premaxilla width was detected (p = 0.037). Anterior basal angle showed a significant increase too. Except for the intermolar width (p = 0.045), no significant changes were identified in the transversal dimensions. Conclusion NAM therapy could potentially serve as an effective tool in mitigating the severity of bilateral cleft deformities at a short-term interval without interfering with maxillary growth. However, long-term studies are required to confirm the effectiveness of the therapy.

Gingivoperiosteoplasty in Children with Cleft Lip and Palate: The Need for Alveolar Bone Grafting.

This study aimed to determine the efficacy of gingivoperiosteoplasty (GPP) in preventing alveolar bone grafting (ABG) among children with cleft lip and palate (CLP). Retrospective university hospital single center study. Children with CLP treated with GPP from 2000-2015 were included. Those under eight years of age, without definitive conclusions regarding need for ABG or with incomplete data were excluded. Included patients were analyzed for demographics, cleft type, age at GPP, associated cleft surgery, use of nasoalveolar molding (NAM), indication for ABG, operating surgeon and presence of residual alveolar fistula. T-tests and Fisher's exact tests were utilized for statistical analysis. The need for ABG. Of the 1682 children identified with CLP, 64 underwent GPP and met inclusion criteria. 78% of patients with CLP who underwent GPP were recommended for ABG. Those who received GPP at a younger age (P = .004) and at the time of initial cleft lip repair (P = .022) were less likely to be recommended for ABG. Patients with complete CLP were more likely to be recommended for ABG than patients with cleft lip and alveolus only (P = .015). The operating surgeon impacted the likelihood of ABG (P = .004). Patient gender, race, ethnicity, laterality, and NAM were not significantly associated with recommendation for ABG. GPP does not preclude the need for ABG. Therefore, the success of ABG after GPP and maxillary growth restriction should be analyzed further to determine if GPP is a worthwhile adjunct to ABG in cleft care.

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).

A Retrospective Review on the Effects of Nasoalveolar Molding on Infant Weight Gain and Time to Primary Lip Repair in Unilateral and Bilateral Cleft Lip and Palate.

In patients with severe cleft deformities, nasoalveolar molding (NAM) can improve long-term lip and nasal symmetry by reducing the size of the cleft, better aligning the alveolus, lip, and nose, and making the primary lip repair more predictable. Despite the increasing number of published studies on modified NAM techniques, the effects of NAM on weight gain and time to primary lip repair remain less studied. This study aims to evaluate the effect of NAM on feeding, weight gain, growth velocity, and time to primary lip repair in patients with complete unilateral and bilateral cleft lip and palate (BCLP). A retrospective, single-institution review was conducted to identify patients with complete unilateral and BCLP treated between January 2005 and June 2020. The following outcomes were measured: age at the time of lip and palate repairs; weight, height, and BMI on the date of lip repair; and growth velocity. Crude and standardized morbidity ratio-weighted differences in outcome means and 95% confidence intervals were estimated using t tests. Seventy-one patients were included in the study, 30 of whom underwent NAM. On average, patients treated with preoperative NAM underwent lip repair later than patients who were not treated with NAM. They also had a greater growth velocity and BMI when compared to their non-NAM counterparts. These differences, however, were not statistically significant. This study explores the relationships between the use of NAM and preoperative weight gain, as well as time to lip repair in patients with complete unilateral and BCLP. Additional studies may be needed to better elucidate the effect of NAM on weight gain and the time required for surgical repair of the cleft lip and palate.

Treatment Outcomes of Lip Taping in Patients with Non-syndromic Cleft Lip and/or Palate: A Systematic Review and Meta-analysis.

To conduct a systematic review of the data in peer-reviewed medical literature and evaluate the effectiveness of lip taping as a pre-surgical naso-alveolar molding (NAM) technique in infants with cleft lip and/or palate. An electronic search of various databases for relevant studies, regardless of date, from inception to June 2023 was carried out and evaluated. After completing the electronic search and applying our inclusion/exclusion criteria, 6 studies-2 randomized control trials, 2 non-randomized studies, and 2 case series-were included. Data extraction of relevant articles was done independently by 2 authors. Quality assessment was done using the JBI prevalence critical appraisal tool and certainty of evidence was carried out by GRADE approach. Nasolabial Aesthetics, Dentoalveolar Relationship. A total of six studies were included in the current review. Meta-analysis was carried out, and forest plots were obtained for a single mean from the lip-taping group. 3 studies had a low risk of bias, while 3 studies displayed a serious risk of bias. Significant improvement in various outcome measures was noted with lip taping when compared with the control group although the certainty of evidence was very low. When compared to no therapy, lip taping appears to ameliorate dentoalveolar measurements and nasolabial aesthetics. To increase our knowledge of lip taping, more research will be needed in the future, as there are not many studies to prove lip taping is better than other treatment approaches.

3D nasoalveolar moulding: A complete digital workflow model

Nasoalveolar moulding (NAM) is a paradigm shift from the presurgical orthopaedics used extensively over the past 20 years in infants with cleft lip and palate. It has been proposed that the gap between the clefted segments be filled up before surgical repair via presurgical nasoalveolar moulding. To attain the best practical and aesthetic results, it is a straightforward yet effective treatment that must be started at the appropriate age and time. In order to enhance treatment outcomes, convenience of use, compliance, and cost-effectiveness, recent developments in NAM therapy have focused on implementing changes to the nasal stent or intraoral moulding plate. Specifically, 3D technology has been used to improve the efficiency of NAM device design and develop standardised, objective methods of determining progressive morphological changes during therapy. The article discusses various methods that use 3D printing technology to produce tangible components from a virtual therapeutic strategy. It also looks at how developments in computational methods and printing materials could open up novel opportunities for computer-assisted NAM therapy.

3-Dimensional Evaluation of Two PNAM Techniques (Modified Grayson & AlignerNAM) on Facial Soft Tissue Morphology: A Randomised Clinical Trial.

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. Randomised clinical trial. Institutional study. Participants: 20 UCLP patients allocated to two groups (10 patients each). 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). Changes in facial and nasolabial morphology. 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. Aligner NAM and Modified Grayson technique are equally effective PNAM methods with similar clinical results in nasolabial morphology after lip repair surgery.

Cytotoxicity Evaluation of Various Composite Resin Materials: An In Vitro Study.

Aim This study aimed to determine and comparethe cytotoxicity of light-cured composite resin (Enlight light cure composite (Ormco, Glendora, California, USA)), light-cured acrylic resin (Orthocryl LC (Dentaurum, Ispringen, Germany)), and the self-cure acrylic (DPI RR cold cure acrylic (Dental Products of India, Bombay Burmah Trading Corporation Ltd., Mumbai, India)) material and to determine which component is best to be used for the purpose of nasal stent fabrication in the nasoalveolar molding (NAM) technique for cleft therapy. Methods Circular discs made from Enlight light cure composite, Orthocryl LC, and self-cure acrylic were submerged for 24 hours in gingival fibroblast media (three discs of each material) and control medium (three discs of each material) that were both contained in plates. After analyzing the optical densities of the plates, the cytotoxicity of the products was assessed by measuring cell viability using the 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT) assay. The compiled data was analyzed using IBM SPSS Statistics for Windows, V. 23.0 (IBM Corp., Armonk, NY). The normality of the data was evaluated using the Shapiro-Wilk test.One-way analysis of variance (ANOVA) and pairwise comparison made with Tukey's honestly significant difference (HSD) post hoc test with a significance level (p) of 0.05 were considered. Results The percentage of cell viability was between 80% and 150%. A significantmean difference was noted in the cell viability between the three groups (p=0.009). High mean cell viability was seen in Orthocryl LC. However, there was no significant mean difference between Orthocryl LC and Enlight light cure composite material (p=0.854). Conclusion Both Orthocryl LC and Enlight light cure composite materials are less cytotoxic when compared to the self-cure acrylic resin material and can be used to fabricate the nasal stent component for infants with cleft defects, undergoing NAM procedure.