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).

A systematic review of barriers to accessing cleft care worldwide.

PURPOSE: Patients with cleft lip/palate need an interdisciplinary approach. Delays in the care of these patients and difficulties in accessing health services have been reported in different low-, middle-, and high-income countries. This study aimed to characterize worldwide publications on access to cleft lip and palate health treatment. METHODS: Databases were selected systematically and searched until July 2021. The review process followed standard methods for systematic reviews. The study quality was evaluated using the Strengthening the Reporting of Observational studies in Epidemiology guidelines for observational studies. RESULTS: A total of 289 publications were identified using our search strategy. After reviewing the titles and reading the abstracts and full text, 16 studies met the inclusion criteria in the review. In one study, financial difficulties obtained the attention of the professionals who attended to cleft lip/palate patients. Ethnic disparities, problems in transportation, and long distances between users and health centers were found. Additionally, there was misinformation about treatment and follow-up among the caregivers of patients with cleft lip/palate. CONCLUSION: When reviewing the literature on access to health services for patients with cleft lip/palate, barriers were reported in access to information, physical access to care centers, financial resources to cover expenses for treatment, and opportunities in care.

Comparison of craniomaxillofacial morphology in children with unilateral cleft lip and palate treated with/without presurgical nasoalveolar molding - a retrospective study with a mean age of 5 years.

OBJECTIVES: 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. MATERIALS AND 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. CLINICAL RELEVANCE: 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.

Predictors for long-term relapse of orthodontic treatment in patients with cleft lip and palate. A clinical follow-up study.

OBJECTIVES: To identify predictors for long-term relapse of orthodontic therapy in patients with cleft lip and palate (CLP). MATERIALS AND METHODS: Patients with uni- and bilateral non-syndromal CLP were followed up at least two years after completion of their orthodontic therapy. Plaster casts of the start of treatment (T1), after completion of treatment (T2), and at follow-up (T3) were measured using the modified Huddart Bodenham Index. Characteristics of multidisciplinary therapy were taken from the patient files. Potentially influencing factors of relapse were investigated using logistic regression analyses and Spearman correlations. RESULTS: In total 58.07% of the included 31 patients showed a stable treatment outcome at follow-up after an average of 6.9 years. Even if relapse occurred, 61.54% of these patients still showed improvement regarding their occlusion compared to baseline. Predictors for the occurrence of relapse were the severity of dysgnathia at baseline (p = 0.039) and the extent of therapeutic change (p = 0.041). The extent of therapeutic change was additionally a predictor for the extent of post-therapeutic relapse (ρ = 0.425; p = 0.019). CONCLUSIONS: Patients with CLP benefit from their orthodontic therapy in the long term despite an increased tendency to relapse. CLINICAL RELEVANCE: Results of this long-term study could be used to adapt the treatment concept for patients with CLP and reinforce the significance of a patient-centered orthodontic treatment concept for affected patients.

Impact of an International Training on Interventionists' Expertise in Cleft Palate Speech: Results From Oaxaca, Mexico.

PURPOSE: International cleft lip and palate surgical charities recognize that speech therapy is essential for successful care of individuals after palate repair. The challenge is how to ensure that cleft speech interventionists (i.e., speech-language pathologists and other speech therapy providers) provide quality care. This exploratory study investigated effects of a two-stage cleft training in Oaxaca, Mexico, aimed at preparing speech interventionists to provide research-based services to individuals born with cleft palate. Changes in the interventionists' content knowledge and clinical skills were examined. METHOD: Twenty-three cleft speech interventionists from Mexico, Guatemala, and Nicaragua participated in a hybrid two-stage training, completing an online Spanish cleft speech course and a 5-day in-person training in Oaxaca. In-person training included a didactic component and supervised clinical practice with 14 individuals with repaired cleft palates. Testing of interventionists' content knowledge and clinical skills via questionnaires occurred before the online course (Test 1), immediately before in-person training (Test 2), and immediately after in-person training (Test 3). Qualitative data on experience/practice were also collected. RESULTS: Significant increases in interventionists' overall content knowledge and clinical skills were found posttraining. Knowledge and clinical skills increased significantly between Tests 1 and 2. Clinical skills, but not knowledge, showed further significant increases between Tests 2 and 3. Posttraining, interventionists demonstrated greater expertise in research-based treatment, and fewer reported they would use nonspeech oral motor exercises (NSOME). CONCLUSIONS: Findings provide preliminary support for such two-stage international trainings in preparing local speech interventionists to deliver high-quality speech services to individuals born with cleft palate. While content knowledge appears to be acquired primarily from the online course, the two-stage training incorporating in-person supervised practice working with individuals born with cleft palate may best enhance continued clinical skill development, including replacement of NSOME with evidence-based speech treatment. Such trainings contribute to building capacity for sustainable quality services for this population in underresourced regions.

[Digital Concepts for the Care of Newborns with Craniofacial Anomalies]. / Digitale Konzepte für die Versorgung von Neugeborenen mit kraniofazialen Anomalien.

The treatment of newborns with craniofacial abnormalities such as cleft lip and/or palate poses special challenges for healthcare providers. Often, the collaboration of an interdisciplinary team of pediatricians, orthodontists, and oral and maxillofacial surgeons is necessary. Therapy using feeding or stimulation plates can improve feeding and strengthen orofacial muscle tone. The treatment of patients with cleft lip and palate using conventionally manufactured feeding plates as well as the treatment of patients with reduced orofacial muscle tone through stimulation plates therapy are established and widely used methods. The conventional production of these plate appliances can lead to serious complications such as swallowing of impression material and airway obstruction due to aspiration. Through an innovative, entirely digital workflow using computer-assisted design and manufacturing of the appliances in a 3D printer, risks can be minimized and time and costs can be saved. This article aims to explain the digital workflow of treating newborns with 3D CAD/CAM feeding and stimulation plates through two case studies.

Investigation of the effectiveness of articulation therapy through tele-practice on children with cleft palate in Khuzestan Province during COVID-19 pandemic.

INTRODUCTION: A cleft palate is a common type of facial malformation. Compensatory articulation errors are one of the important causes of unclear speech in children with cleft palate. Tele-practice (TP) helps to connect therapists and clients for assessment and therapy. Our goal is to investigate the effectiveness of articulation therapy through tele-practice on cleft palate children in Khuzestan Province during the COVID-19 pandemic. MATERIALS & METHODS: Before starting the treatment, a 20-min speech sample was recorded individually from all the children. Speech intelligibility and the percentage of correct consonants were assessed for each speech sample. The control group received treatment sessions in person at the cleft palate center, and the other group received treatment via tele-practice using the ZOOM platform. Treatment sessions were provided in the form of 45-60-min group sessions, twice a week, for 5 weeks (10 sessions in total). After 10 treatment sessions, the speech sample was recorded again. The level of parental satisfaction was measured using a Likert 5-level survey. RESULTS: The mean score of intelligibility of the two groups decreased (-1.4400 and 0.7200). The two groups' mean percentage of correct consonants increased. (26.09 and 17.90). In both groups, the mean score of parents' satisfaction with the treatment was high (3.44 and 3.84). The mean of difference before and after the speech intelligibility and the percentage of correct consonants variables in both groups was statistically significant (P = 0.001 and P = 0.002, respectively). In both groups, the satisfaction variable was not associated with a statistically significant difference (P = 0.067). CONCLUSION: The effectiveness of in-person therapy over a certain period of time is higher than tele-practice. Nevertheless, the results demonstrated an increase in the intelligibility of speech and the percentage of correct consonants in both groups, thus proving the effectiveness of articulation therapy in correcting compensatory articulation errors in children with cleft palate through in-person and tele-practice.

Auckland Regional Cleft Palate Service: service accessibility and speech outcomes.

AIM: This study explored speech outcomes for five-year-olds born with cleft palate residing in the Auckland Regional Cleft Palate Service catchment, with a focus on ethnicity and geographical influences on service accessibility and speech outcomes. METHODS: A retrospective audit of children born with cleft palate between 2013-2016 was conducted (n=89), including secondary surgeries, ethnicity, distances travelled, services offered and attended. Speech outcomes at five years were compared to international benchmarking. RESULTS: Seventy-nine children were included; 10 were lost to follow-up before their 5 years review. At 5 years, 30% children presented with moderate to severe velopharyngeal incompetence; 30% had residual cleft speech characteristics which warranted speech therapy intervention. There was no significant difference in speech outcomes for Maori vs non-Maori. Attendance at clinic was not significantly associated with distance from centre. However, Maori had significantly lower attendance at clinic appointments and were significantly more likely to be referred to community services. CONCLUSION: Auckland Regional speech outcomes are better than the national average, yet still do not compare favourably with international benchmarking. While speech outcomes were not associated with ethnicity, attendance at specialist clinic appointments was lower in Maori. Community services were offered, but attendance at, and satisfaction with, these appointments is unknown. Further work is needed to reach all children regionally in a timely manner to ensure Aotearoa New Zealand speech outcomes meet international standards.

Effects of nasoalveolar molding on nasolabial aesthetics in patients with cleft lip and palate during pre-adolescence: A systematic review and meta-analysis of retrospective studies.

This study aims to analyze long-term effects of nasoalveolar molding (NAM) as a part of cleft primary management protocols on nasolabial aesthetics for patients with non-syndromic cleft lip and palate by conducting a systematic review and meta-analysis. Six electronic databases and two journals were searched up to July 2023. Studies comparing nasolabial outcomes between NAM and non-NAM protocols were selected for further analysis. Nasolabial aesthetics were the outcome of interest. Data extraction, methodological quality assessment, risk of bias assessment, meta-analysis and subgroup analysis were performed. Seven retrospective cohort studies were selected for a qualitative review and four for a quantitative analysis. The risk of bias assessment was moderate for most studies. Only studies utilizing the Asher-McDade rating (AMR) were included for meta-analyses. The protocols with NAM exhibited a significantly lower AMR score for vermillion border than other protocols. AMR scores for nasal form and nasal symmetry from protocols with NAM were significantly lower than protocols without any pre-surgical infant orthopaedics (PSIO) but not significantly different from protocols with other PSIO techniques. The AMR score for nasolabial profile from protocols with NAM was not significantly different from other protocols. However, subgroup analysis demonstrated that protocol combining NAM and primary rhinoplasty significantly lowered AMR scores for nasal form, nasal symmetry and nasolabial profile. For patients with unilateral cleft lip with or without palate (UCLP), this study found that a protocol combining NAM and primary rhinoplasty improved nasolabial outcomes while a protocol with NAM alone offered only limited benefits. For patients with BCLP, the available evidence remains inconclusive. Performing NAM in combination with primary rhinoplasty improves nasolabial aesthetics in patients with UCLP. PROSPERO (CRD4202128384).

Comparative assessment of facemask therapy with and without skeletal anchorage in growing Class III patients with unilateral cleft lip and palate (UCLP): A single-center, prospective randomized clinical trial.

OBJECTIVE: The purpose of this study was to evaluate the maxillary protraction effect of facemask therapy with and without skeletal anchorage in growing Class III patients with unilateral cleft lip and palate (UCLP). MATERIALS AND METHODS: Thirty patients (aged 9-13 years) with UCLP having a GOSLON score 3 were selected for this prospective clinical study. The patients were allocated into two groups using computer generated random number table. Group I (facemask therapy along with two I shaped miniplates, FM + MP) and Group II (facemask mask along with tooth-anchored appliance, FM). Skeletal and dental parameters were evaluated on pre- and post-treatment lateral cephalograms and pharyngeal airway on cone-beam computed tomography systems (CBCT) for assessment of the treatment changes. RESULTS: Both methods proved to be effective with statistically significant improvements in skeletal and dental parameters (p < .05). Skeletal parameters (e.g., SNA, convexity-point A, ANB) with the FM + MP group showed greater change compared to those with FM group (SNA, 2.56°; convexity-point A, 1.22°; ANB, 0.35°). Significant proclination of maxillary incisors was observed in the FM group as compared to FM + MP group (U1 to NA, 5.4°; 3.37 mm). A statistically significant increase in pharyngeal airway volume was noted in both groups (p < .05). CONCLUSION: While both therapies are effective in protracting the maxilla in growing patients with UCLP, the FM + MP allows for a greater skeletal correction, minimizing the dental side effects seen with FM therapy alone. Thus, FM + MP appears to be a promising adjunct in reducing the severity of Class III skeletal correction needed in patients with cleft lip and palate (CLP).

Do Adult Naïve Listeners Perceive Differences in Speech Before and After Therapy for Cleft Palate Speech Disorders? A Reliability Study of Perceptual Speech Ratings.

PURPOSE: This study compared the interrater reliability of adult naïve listeners' perceptual assessments of different speech variables in children with a cleft palate with or without a cleft lip (CP ± L). In addition, the study investigated whether the listeners were able to perceive differences in these speech variables before and after speech therapy for cleft palate speech disorders. METHOD: Thirty-four speech samples of 14 children with a CP ± L (14 samples collected immediately before 10 hr of speech intervention, 14 samples collected immediately after speech intervention, and six randomly selected samples that were duplicated to assess intrarater reliability) were perceptually assessed by 26 adult naïve listeners. The listening panel consisted of nine men and 17 women (age range: 18-51 years). The speech variables included speech understandability, speech acceptability, hypernasality, hyponasality, nasal airflow, and articulation, which were assessed on a visual analog scale. Furthermore, the need for speech therapy was assessed. RESULTS: Good to very good interrater reliability was observed for the naïve listeners' ratings of all speech variables. A significant time effect was found for the pre- and postevolution of the speech variables "speech understandability," "speech acceptability," "nasal airflow," and "articulation." This time effect indicates an improvement of these variables postintervention. According to the naïve listeners, children were less in need of additional speech therapy after the 10-hr intervention period compared to assessments before this intervention period. CONCLUSIONS: Adult naïve listeners perceptually identified an improvement in different speech variables after 10 hr of cleft palate speech therapy. These findings confirm previous assessments of expert speech-language pathologists and suggest that speech improvements after cleft palate speech therapy can also be perceived by communication partners outside the therapy room. Perceptual ratings of naïve listeners can, thus, be used to add life-situation significance to the assessments of experts. Future research could include both expert raters and caregivers or relatives of children with a CP ± L in listening panels, as previous knowledge on craniofacial anomalies may lead to different results.

Effects of nasoalveolar molding on maxillary arch dimensions and malocclusion characteristics in primary dentition patients with cleft lip and palate.

BACKGROUND: Nasoalveolar molding (NAM) is a presurgical orthopedic technique used in the management of cleft lip and palate deformities. Despite the widespread use of NAM therapy, there is a need for further investigation to assess its specific effects on arch dimensions and malocclusion characteristics. AIM: To evaluate the effects of NAM therapy on maxillary arch dimensions and malocclusion characteristics in patients with unilateral cleft lip and palate (UCLP) and bilateral cleft lip and palate (BCLP). DESIGN: Patients in primary dentition were referred to the Institutional Department of Orthodontics. The NAM group consisted of 21 patients with UCLP (mean age 4.7 ± 0.7 years) and 12 patients with BCLP (mean age 4.8 ± 0.7 years). Sixteen patients with UCLP (mean age 4.9 ± 0.9 years) and five patients with BCLP (mean age 5.4 ± 1.1 years) were included in the non-NAM group. The plaster models of all patients were digitized. Dental arch dimensions and malocclusion characteristics were analyzed via digital software. One-way ANOVA with Bonferroni correction was used for statistical analysis. RESULTS: Intercanine and intermolar widths showed statistically significant differences according to the cleft type (p < .01). There was no statistically significant effect of NAM therapy on maxillary arch parameters and malocclusion characteristics (p > .05). The prevalence of anterior crossbite was 12.1% in the NAM group and 23.8% in the non-NAM group. CONCLUSION: NAM therapy did not affect the maxillary arch dimensions and malocclusion characteristics in patients with UCLP and BCLP. The cleft type was the main factor, leading to a significant difference in maxillary widths.

Continuing Education Needs of Speech-Language Pathologists for Assessing and Treating Children With Cleft Palate: A National Analysis Across Areas of Varying Population Density.

PURPOSE: The purpose of this study was to identify training gaps and continuing education (CE) needs for speech-language pathologists (SLPs) in evaluating and treating children with cleft palate across and among areas of varying population density. METHOD: An anonymous 35-question survey lasting approximately 10-15 min was created in Qualtrics based on a previously published study. The survey information and link were electronically distributed to American Speech-Language-Hearing Association (ASHA)-certified SLPs through ASHA listservs, social media, individual-state SLP organizations, and an e-mail list of publicly listed SLPs. A total of 359 survey responses were collected. RESULTS: Respondents varied in terms of age, type of certification, practice location, and clinical experience with cleft palate, with the largest percentage (46.7%) of respondents in a school-based setting. Only 28.5% reported currently feeling comfortable treating children with cleft palate. Respondents reported conventions/conferences (25.4%) and webinars (23.2%) were the most helpful resources, but DVDs were frequently not used for CE. Information from the child's cleft team (84.4%) and mentors/colleagues (70%) were considered high-quality resources. Respondents indicated information on treatment of articulation (79.2%) and resonance (78.4%) disorders as well as specific therapy techniques (76.9%) would be very helpful for clinical practice. Population density significantly influenced how respondents ranked the perceived helpfulness and quality of different resources as well as desired topics for future resources. CONCLUSIONS: There is a continued need for adequate training and CE opportunities for SLPs, particularly related to assessing and treating children with cleft palate. Increased access to high-quality CE resources will be key to filling educational gaps present for SLPs, especially in areas of low-population density. SUPPLEMENTAL MATERIAL: https://doi.org/10.23641/asha.24891423.

Effects of Alt-RAMEC protocol with facemask therapy in cleft lip palate patients in a sample of Pakistani population.

OBJECTIVE: The objective of the study is to evaluate the skeletal, dentoalveolar and soft tissue changes before and after treatment with Alt-RAMEC protocol and protraction headgear in comparison to the controls. MATERIAL AND METHODS: A quasi experimental study was conducted in the orthodontic department on 60 patients of cleft lip and palate. These patients were divided into two groups. Group I was the Alt-RAMEC group that underwent Alt-RAMEC protocol followed by facemask therapy while group II was the control group that underwent RME and facemask therapy. Total treatment time in both the groups was approximately 6 to 7 months. Mean and standard deviation was calculated for all the quantitative variables. Pre and post treatment changes between treatment and control groups were made using paired t-test. Intergroup comparison between treatment and control group was analyzed using independent t-test. Significance for all tests was predetermined at a P-value of ≤ 0.05. RESULTS: The Alt-RAMEC group showed significant forward movement of maxilla and improvement in the maxillary base. A remarkable improvement in SNA was seen. The overall outcome was better maxillo-mandibular relationship as shown by positive ANB values and angle of convexity. More effect on maxilla and least effect on mandible was notified with Alt-RAMEC protocol and facemask therapy. Improvement in transverse relationship was also evident in the Alt-RAMEC group. CONCLUSION: Alt-RAMEC protocol in combination with protraction headgear is a better alternative to treat cleft lip and palate patients in comparison to the conventional protocol.

Challenges for dental care of the paediatric patient born with cleft lip and/or palate.

This paper forms part of a series on the management of patients with cleft lip and/or palate (CLP). Children with CLP have a higher incidence of dental caries and dental anomalies. This paper explains the important roles of both the general dental practitioner and specialist paediatric dentist on the cleft team in managing these children alongside the multidisciplinary team.

The restorative dentistry management of adult cleft patients: 'the adult returner'.

This paper will discuss the management of adult patients with cleft lip and palate who return to care, often many decades after their initial course of treatment. This can be a very complex group of patients to treat as they often present with anxiety about dental care and often have other long-standing psychosocial issues. Working very closely with the multi-disciplinary team and the general dental practitioner is crucial to the successful outcome of care. This paper will outline the most common complaints that these patients may present with and the restorative dentistry solutions that are available to address them.

The role of the clinical psychologist within a cleft service.

Clinical psychologists are core members of UK cleft services. This paper outlines the variety of ways in which clinical psychologists work across the lifespan to promote the psychological wellbeing of those born with a cleft and their families. In the context of dental or orthodontic treatment, this involves a combination of early intervention and advice, psychological assessment or specialist psychological therapy for individuals experiencing dental anxiety or anxiety regarding the appearance of their teeth. This paper therefore aims to highlight the varying roles which clinical psychologists play in the provision of cleft-related dental care, often alongside multidisciplinary colleagues.

Articulating the issues: speech assessment and intervention in cleft lip and palate.

This paper describes the impact of cleft lip and palate on speech. It provides an overview for the dental clinician of the key issues affecting speech development and clarity. The paper summarises the complex speech mechanism and cleft-related factors that affect speech, including palatal, dental and occlusal anomalies. It outlines the framework for speech assessment throughout the cleft pathway and provides a description of cleft speech disorder, as well as describing treatment approaches for cleft speech and velopharyngeal dysfunction.This is followed by a spotlight on speech prosthetics for treating nasal speech, with an emphasis on joint management by the Speech and Language Therapist and Consultant in Restorative Dentistry. This includes the core multidisciplinary approach, clinician and patient-reported outcome measures, and brief discussion of national developments in this area.The importance of multidisciplinary cleft care is highlighted and, within this, the essential interaction between speech and dental clinicians in providing routine care, as well as in delivering a highly specialist speech prosthetics service.

Global perspectives in orofacial cleft management and research.

Orofacial clefts (OFCs) refer to clefts of the lip and palate, a heterogeneous group of relatively common congenital conditions that can cause mortality and significant disability if untreated, and residual morbidity even when treated with multidisciplinary care. Contemporary challenges in the field include: lack of awareness of OFCs in remote, rural and impoverished populations; uncertainties due to lack of surveillance and data gathering infrastructure; inequitable access to care in some parts of the world; and lack of political will combined with lack of capacity to prioritise research.OFCs present clinically as either syndromic or non-syndromic, with the latter either being isolated or in conjunction with other malformations; however, many registries still do not differentiate between these fundamentally different entities and lump a spectrum of cleft types and sub-phenotypes together. This has implications for treatment, research and ultimately, quality improvement.This paper deals with the challenges in contemporary management in terms of care and the prospects and possibilities for primary prevention of non-syndromic clefts. In terms of management and optimal care, there are also challenges in the provision of multi-disciplinary treatment and management of the consequences of being born with OFCs, such as dental caries, malocclusion and psychosocial adjustment.