The field of 3D printing is continuing its rapid development in both academic and industrial research environments. The development of 3D printing technologies has opened new implementations in rapid prototyping, tooling, dentistry, microfluidics, biomedical devices, tissue engineering, drug delivery, etc. Among different 3D printing techniques, photopolymerization-based process (such as stereolithography and digital light processing) offers flexibility over the final properties of the 3D printed materials (such as optical, chemical, and mechanical properties) using versatile polymer chemistry. The strategy behind the 3D photopolymerization is based on using monomers/oligomers in liquid state (in the presence of photoinitiators) that can be photopolymerized (via radical or cationic mechanism) upon exposure to light source of different wavelengths (depending on the photoinitiator system). An overview of recent evolutions in the field of photopolymerization-based 3D printing and highlights of novel 3D print...
Oral diseases are a major global public health problem affecting over 3·5 billion people. However, dentistry has so far been unable to tackle this problem. A fundamentally different approach is now needed. In this second of two papers in a Series on oral health, we present a critique of dentistry, highlighting its key limitations and the urgent need for system reform. In high-income countries, the current treatment-dominated, increasingly high-technology, interventionist, and specialised approach is not tackling the underlying causes of disease and is not addressing inequalities in oral health. In low-income and middle-income countries (LMICs), the limitations of so-called westernised dentistry are at their most acute; dentistry is often unavailable, unaffordable, and inappropriate for the majority of these populations, but particularly the rural poor. Rather than being isolated and separated from the mainstream health-care system, dentistry needs to be more integrated, in particular with primary care services. The global drive for universal health coverage provides an ideal opportunity for this integration. Dental care systems should focus more on promoting and maintaining oral health and achieving greater oral health equity. Sugar, alcohol, and tobacco consumption, and their underlying social and commercial determinants, are common risk factors shared with a range of other non-communicable diseases (NCDs). Coherent and comprehensive regulation and legislation are needed to tackle these shared risk factors. In this Series paper, we focus on the need to reduce sugar consumption and describe how this can be achieved through the adoption of a range of upstream policies designed to combat the corporate strategies used by the global sugar industry to promote sugar consumption and profits. At present, the sugar industry is influencing dental research, oral health policy, and professional organisations through its well developed corporate strategies. The development of clearer and more transparent conflict of interest policies and procedures to limit and clarify the influence of the sugar industry on research, policy, and practice is needed. Combating the commercial determinants of oral diseases and other NCDs should be a major policy priority.
N. Tinanoff, R. Baez, Carolina Diaz Guillory
et al.
BACKGROUND This paper is a summary of the proceedings of the International Association of Paediatric Dentistry Bangkok Conference on early childhood caries (ECC) held in 3-4 November 2018. AIM The paper aims to convey a global perspective of ECC definitions, aetiology, risk factors, societal costs, management, educational curriculum, and policy. DESIGN This global perspective on ECC is the compilation of the state of science, current concepts, and literature regarding ECC from worldwide experts on ECC. RESULTS Early childhood caries is related to frequent sugar consumption in an environment of enamel adherent, acid-producing bacteria in a complex biofilm, as well as developmental defects of enamel. The seriousness, societal costs, and impact on quality of life of dental caries in pre-school children are enormous. Worldwide data show that ECC continues to be highly prevalent, yet infrequently treated. Approaches to reduce the prevalence include interventions that start in the first year of a child's life, evidence-based and risk-based management, and reimbursement systems that foster preventive care. CONCLUSIONS This global perspective on ECC epidemiology, aetiology, risk assessment, global impact, and management is aimed to foster improved worldwide understanding and management of ECC.
Jutarat Phuensuriya, Panida Thanyasrisung, Chutima Trairatvorakul
et al.
Abstract Objective Silver diamine fluoride (SDF) is widely used for caries arrest due to its ease of application, minimal caries removal, low patient discomfort, and cost-effectiveness. However, the recommended 60-second (sec) application time may be impractical in patients with limited compliance. This study evaluated the effects of 10-sec versus 60-sec SDF application, with and without light curing, on arresting artificial dentinal caries by analyzing three parameters—percentage change in mean lesion depth (%∆LD), percentage change in mean mineral density (%∆MD), and penetration depth (PD)— assessing surface morphology and elemental composition of the lesions. Materials and methods Artificial dentin lesions were prepared on 40 slices from 10 permanent molars and randomly assigned to four groups (n = 10): (1) SDF60 (60 s application), (2) SDF10 (10 s application), (3) SDF60LC (60 s application + 20 s light curing), and (4) SDF10LC (10 s application + 20 s light curing). The caries activity was generated by a 7-day bacterial pH-cycling model. Micro-computed tomography (Micro-CT) was used to analyze %∆LD, %∆MD, and PD. Surface morphology and elemental composition were examined using scanning electron microscopy (SEM) and energy-dispersive X-ray spectroscopy (EDS). Results SDF60LC produced the greatest reduction in lesion depth (%∆LD), the largest increase in mineral density (%∆MD), and the highest penetration depth (PD). SDF10 showed significantly less %∆LD and %∆MD compared with both SDF60 and SDF60LC. %∆LD and %∆MD of SDF10LC were not significantly different from either SDF60 or SDF10. However, SDF10LC achieved significantly greater PD than SDF10. Conclusions A 60-sec SDF application with light curing appeared to produce the most favorable outcomes in terms of lesion depth reduction, mineral density gain, and penetration depth. A 10-sec SDF application with light curing produced results comparable to a 60-sec SDF application. Clinical relevance Although a 60-sec SDF application with light curing seems the most effective under laboratory conditions, a shortened 10-sec SDF application with light curing may offer a practical alternative in low-compliance patients. Clinical studies are required to confirm these findings.
Amina Elzeiny, Ahmed Loutfy, Corrien Van Belkum
et al.
Background: Nursing students often encounter emotional challenges when facing death during their clinical training, which can negatively impact their academic performance and mental well-being. As they provide crucial support to patients and their families, this responsibility can induce significant stress. Objective: This study aims to examine nursing students’ attitudes toward death and dying and to identify the demographic and educational factors influencing their preparedness for end-of-life care in the United Arab Emirates context. Methods: In March 2025, a cross-sectional study was conducted using a convenience sample of 122 nursing students (senior and junior) enrolled in clinical placements at a university in the United Arab Emirates. Data collection utilized the validated Death Attitude Profile-Revised (DAP-R) and Frommelt Attitudes Toward Care of the Dying (FATCOD) scales as assessment tools. Results: The study showed that nursing students typically hold neutral attitudes toward caring for patients nearing the end of life. There are statistically significant correlations between age, education level, grade point average, clinical scores, and overall scores on the DAP-R scale, as well as the FATCOD Scale, among the participants. Conclusions: While many students showed some acceptance of death, high degrees of fear, avoidance, and escape acceptance had a significant impact on their views about end-of-life care. The findings indicate that emotional distress and insufficient training may act as impediments to compassionate treatment. Furthermore, the comparatively low FATCOD ratings indicate a need for better integration of palliative care instruction within the nursing curriculum. Structured clinical exposure, psychological coping mechanisms, and reflective learning opportunities could all be used to help students gain the essential confidence and emotional resilience.
Hettkamp, Julian, Becker, Jan C., Scherzer, Sönke
et al.
Introduction: Stays abroad in the form of study visits and clinical traineeships, for example, have been rare in dentistry degree programmes in Germany to date. The new ZApprO (date of issue: 8 July 2019) offers the opportunity to integrate stays abroad into the degree programme through the introduction of modules, ECTS points and clinical traineeships, among other things. The aim of this study was to analyse the student perspective on this topic.
Methodology: In the summer term of 2021, a voluntary and anonymous online survey was conducted among dental students at the University of Münster. In addition to demographic data, the questionnaire also included key questions on content.
Results: With a response rate of 55%, a total of 371 students took part in the survey. 96% of the study participants stated that they would like to gain experience abroad as part of their studies, almost half of them even in the case of missing or only partial recognition of academic achievements. This includes clinical traineeships (30%) and semester-long stays (32%) or both (28%). The loss of time in the progression of studies, financing as well as time-consuming planning and family obligations are the most frequently cited reasons against a stay abroad.
Conclusion: The survey shows a very high level of interest among dental students in university-supported stays abroad. This includes both shorter periods of time, such as clinical traineeships, as well as longer stays, e.g. as part of Erasmus collaboration programmes. Based on the results, university-supported stays abroad should be made possible.
Introduction: Debonding of silicone prostheses from metal substructures is a frequently reported complication in prosthodontics. Polyether ether ketone (PEEK) has emerged as a promising alternative framework material owing to its favourable biomechanical properties; however, its limited bond strength to silicone remains a concern. The present study aimed to evaluate the shear bond strength between PEEK and maxillofacial silicone following laser etching of PEEK and subsequent accelerated ageing.
Materials and methods: According to ISO 10477:2020, 128 PEEK specimens were fabricated using Computer-Aided Design and Computer-Aided Manufacturing (CAD/CAM) with 10 mm diameter and 3 mm thickness, and silicone specimens with 5 mm diameter and 2.5 mm height. The specimens were categorised into: Group 1–no surface treatment, Group 2–Al2O3 air abrasion, Group 3–98% sulphuric acid etching, and Group 4–laser irradiation. The silicone specimens were bonded to PEEK and kept at room temperature for 24 h for polymerisation, and were subjected to accelerated ageing for 252, 504, and 1,008 h. The shear bond strength was evaluated using universal testing machine at 1 mm/min crosshead speed. The comparison within groups was done using one-way analysis of variance (ANOVA) and multiple group comparison was done using Tukey’s HSD (Honestly Significant Difference) post-hoc analysis.
Results: Statistical analysis showed that surface pretreatment had a significant effect on bond strength (p < 0.05). Laser treatment and air abrasion produced significantly higher bond strengths compared to sulfuric acid etching, while no significant difference was found between laser treatment and air abrasion. Accelerated ageing time also had a significant influence, with bond strength values decreasing progressively from 252 h to 1,008 h across all pretreatment groups.
Conclusion: Surface pretreatment significantly influenced the adhesion of maxillofacial silicone to PEEK. Laser treatment and air abrasion provided superior and statistically comparable bond strengths, whereas sulfuric acid etching was less effective. Accelerated ageing reduced bond strength over time, highlighting the effect of ageing conditions on the durability of adhesion.
Background:
Oral health plays a crucial role in maintaining the general health of an individual. Parkinson disease (PD) has known to disrupt the oral functions. Prosthetic rehabilitation can be done in these patients. However, there is scarcity of literature to assess the effectiveness or impact of rehabilitation with prosthesis either fixed or removable on various oral functions and quality of life (QoL) or satisfaction of PD patients. The purpose of this systematic study was to assess the effectiveness of prosthodontic rehabilitation in patients with PD.
Materials and Methods:
The literature search was conducted in the PubMed and CINAHL database for the articles till 2024 in English language. An exploration of gray literature was also included through Google Scholar. Manual search in the references of the selected articles was also done for relevant articles. The methodological quality assessment of cohort studies was done using Newcastle–Ottawa quality assessment form for Cohort Studies (NOS). Assessment of cross-sectional studies was done using the Appraisal tool for Cross-Sectional Studies (tool) and aassessment of case series was done using JBI critical appraisal tool for case series.
Results:
A total of 6 articles were selected from PubMed, 1 from CINAHL, and 2 from Google Scholar. Four articles studied the masticatory efficiency. Oral perception and motor ability were analyzed in two articles. Oral Health QoL was assessed in four articles. One article studied the electromyographic activity.
Conclusion:
Based on this systematic review, it can be suggested that prosthetic rehabilitation using fixed or removable prosthesis offer potential benefits in PD patients improving the oral functions and QoL. However, there is a dearth of long-term research on evaluation of impact of prosthetic rehabilitation in improving the oral function and QoL of PD patients.
PROSPERO Registration: CRD42024570296.
Philipp Körner, Sandra C. Gerber, Cindy Gantner
et al.
Abstract This pilot study investigated whether sonic-powered application of a bulk-fill resin-based composite (RBC) in Class-II or endodontic access cavities reduces void formation. The crowns and roots of 60 bovine teeth with Class-II cavities (C) and endodontic access cavities (E) respectively, were assigned to ten groups (C1–C5, E1–E5). Cavities were filled with RBC (SDR flow + , one increment) using different application techniques: no adaptation (C1 + E1), spreading of RBC on the cavity surfaces with a dental explorer tip (C2 + E2), low (C3 + E3) or high frequency (C4 + E4) direct activation by inserting a sonic-powered tip into RBC and high frequency indirect activation with an ultrasonic insertion tip (C5 + E5). The restorations were light-cured and investigated for voids using microtomography. The number of voids and percentage of voids related to the volume were statistically analysed (α < 0.05). While most voids in Class-II restorations were observed in C4 (p ≤ 0.0031), no significant differences were found between the other groups (p > 0.05). The percentage of voids showed no differences in E1-E5 (p > 0.05). C4 showed a significantly higher percentage of voids compared to C2 (p < 0.001). There is no benefit in applying sonic vibration when filling Class-II or endodontic access cavities.
ABSTRACT
Introduction: The accumulation of dental plaque is a common cause of dental and oral health problems such as caries and periodontitis, therefore it is necessary to control plaque. Brushing is the most effective way to control plaque. Currently, there are various toothpastes used by the people, one of which is herbal toothpaste. One of the herbal toothpastes that has an antibacterial potential is rambutan honey toothpaste. The purpose of this study was to analyze the effectiveness of rambutan honey toothpaste in reducing the dental plaque index. Methods: this research was Quasi Experimental design research with a pre-test post-test control group design. The twenty samples were divided into three treatment groups, namely the group that brushed teeth with base toothpaste, rambutan honey toothpaste, and aquadest. All samples were asked to brush their teeth using base toothpaste, rambutan honey toothpaste, and aquadest twice, after using toothpaste for one day, the plaque index was measured by the Silness and Loe method. Data were analyzed using Kruskal-Wallis and post hoc Mann-Whitney tests (p<0.05). Results: There was a significant difference between the plaque index score before and after using rambutan honey toothpaste with a p value=0.005 (p≤0.05). The results also showed the effect of brushing teeth with base toothpaste, rambutan honey toothpaste, and aquadest on plaque index with a value of p=0.005 (p≤0.05). The results showed that there was no significant difference in dental plaque index between base toothpaste and rambutan honey toothpaste with a p value=0.583. Conclusion: Rambutan honey toothpaste has a potential in reducing the dental plaque index.
Keywords: plaque index, rambutan honey, toothpaste
Kiran Pohar Manhas, Katelyn Brehon, Jennis Jiang
et al.
Abstract Background Post-stroke visual impairment (VI) is a common but under-recognized care challenge. Common manifestations of post-stroke VI include: diplopia, homonymous hemianopia, oscillopsia secondary to nystagmus, and visual inattention or neglect. In acute care settings, post-stroke VI recognition and treatment are often sub-optimal as emphasis is placed on survival. Stroke survivors with VI often face inconsistencies when accessing care out of hospital because variable availability and subsidization of visual rehabilitation. We sought to identify gaps in care experienced by stroke survivors with VI from stroke survivors’ and care providers’ perspectives. Methods We conducted a qualitative description study across 12 care sites in Alberta, Canada, using semi-structured interviews. Survivor interviews focused on the health system experience. Provider interviews discussed approaches to care, perceived gaps, and current resources. Interviews were audio-recorded and transcribed. Iterative content analysis was completed using NVivo 12. We promoted rigour through an audit trail, open-ended questions, thick description, and collaborative coding. Results We completed 50 interviews: 19 survivor interviews and 31 provider interviews. The majority of survivors were male (n = 14) and recruited from community settings (n = 16). Providers varied in profession and location within the care continuum. Two key themes emerged from the provider and survivor interviews pertaining to (a) facets of visual rehabilitation (sub-themes: access, resources, and multidisciplinary professional interaction); and (b) functioning with post-stroke VI (sub-themes: early experiences post-stroke and living with VI in the real world). Conclusions The visual rehabilitation model needs to be optimized to ensure transparent inter-disciplinary communication and efficient referral pathways. Future research will focus on evaluating the effectiveness of post-stroke care from multiple perspectives in Alberta.
Daryl Lim Joon, Colleen Berry, Benjamin Harris
et al.
IntroductionImage guidance with gold fiducials improves outcomes of prostate radiotherapy. However, gold produces artefact on CT imaging, interfering with contouring and verification. The purpose of this study was to compare polymer to standard gold fiducials using radiotherapy imaging modalities to assess the visibility and artefact.MethodsTwenty eight patients with locally advanced prostate cancer were enrolled, half had three polymer fiducials implanted into the prostate and half underwent insertion of gold fiducials. Patients were imaged with CT, T2 weighted MRI, cone-beam CT (CBCT) and planar KV images. Fiducials were scored for visibility and assessed for CT artefact in surrounding prostate tissue. The artefact was quantified from Hounsfield number histograms and separated into percentile ranges and proportion of voxels in HU normal tissue range of a 2cm sphere surrounding the fiducial.ResultsGold and polymer fiducials were sufficiently visible for CT and CBCT verification. The gold fiducials could be visualized well on KV planar imaging; however, the polymer markers were obscured by pelvic bones. Neither polymer nor gold fiducials could be visualized on MRI. The polymer fiducial produced less artefact than gold on CT, having less voxel spread for the HU percentile ranges and a greater proportion of voxels in the normal tissue range.ConclusionsPolymer fiducials are a more suitable fiducial than gold for CT/CBCT in prostate cancer radiotherapy, demonstrating minimal artefact and good visibility on CT. However, they were not well seen on MRI or KV imaging and thus not suitable for co-registration or planar KV verification.
Neoplasms. Tumors. Oncology. Including cancer and carcinogens
Orofacial clefts have been associated with specific cleft candidate genes which encode regulatory proteins required for orofacial region development. Cleft candidate genes encode proteins involved with the cleft morphopathogenesis process, but their exact interactions and roles are relatively unclear in human cleft tissue. This study evaluates the presence and correlations of Sonic Hedgehog (SHH), SRY-Box Transcription Factor 3 (SOX3), Wingless-type Family Member 3A (WNT3A) and 9B (WNT9B) protein containing cells in different cleft tissue. Non-syndromic cleft-affected tissue was subdivided into three groups—unilateral cleft lip (UCL) (<i>n</i> = 36), bilateral cleft lip (BCL) (<i>n</i> = 13), cleft palate (CP) (<i>n</i> = 26). Control tissue was obtained from five individuals. Immunohistochemistry was implemented. The semi-quantitative method was used. Non-parametric statistical methods were applied. A significant decrease in SHH was found in BCL and CP tissue. SOX3, WNT3A and WNT9B had a significant decrease in all clefts. Statistically significant correlations were found. The significant decrease in SHH could be associated with BCL and CP pathogenesis. SOX3, WNT3A and WNT9B could have morphopathogenetic involvement in UCL, BCL, and CP. Similar correlations imply the presence of similar pathogenetic mechanisms in different cleft variations.
Mahmoud M. Abbas, Khalood W. Abooud, Amjed Qasim Mohammed
et al.
Biochar-based fertilizers, customized to specific soil conditions, have piqued public attention to enhance soil quality and carbon sequestration. The incorporation of biochar into agricultural fields can become a primary factor in the preservation of soil productivity and fertility. However, there is still no conclusive experimental evidence to support this claim. In this study, a split-plot experiment was carried out according to a randomized complete block design (RCBD) using three replications to evaluate the influence of irrigation and varied amounts of biochar-based fertilizer on peanut plants' yield to determine the water use efficiency (WUE). The primary treatment with different irrigation cycles and no irrigation, and the sub-treatment with biochar-based fertilizer of 50, 100, and 150 kg N ha-1 and no fertilizer, were performed in Sulaymaniyah which is located in the east of the Kurdistan Region of Iraq. The results revealed that the seven-day irrigation cycle produces the largest pods and seeds, with 4325 and 2435 kg ha-1 yields, respectively. The 100 kg ha-1 biochar-based fertilizer yielded the highest output, with a pod yield of 3652 kg ha-1 and a seed yield of 1921 kg ha-1. According to the results of the interaction between irrigation management and biochar-based fertilizer, the irrigation treatment had a maximum seed yield of seven-day and the fertilizer treatment had a maximum seed output of 100 kg N ha-1 with an average of 3462 kg ha-1. The variance analysis results indicate that water use efficiency in irrigation management, different levels of biochar-based fertilizer, and their combined effect on total biomass, seed, and pods were significant.
Introduction Reducing sodium intake has been identified as a highly cost-effective strategy to prevent and control high blood pressure and reduce cardiovascular mortality. This study aims to compare the sodium content in processed meat and fish products among five countries, which will contribute to the evidence-base for feasible strategies of sodium reduction in such products.Methods Sodium content on product labels of 26 500 prepackaged products, 19 601 meat and 6899 fish, was collected in supermarkets from five countries using the FoodSwitch mobile application from 2012 to 2018. To be specific, it was 1898 products in China, 885 in the UK, 5673 in Australia, 946 in South Africa and 17 098 in the USA. Cross-sectional comparisons of sodium levels and proportions meeting 2017 UK sodium reduction targets were conducted using Kruskal-Wallis H and the χ2 test, respectively across the five countries.Results The results showed that processed meat and fish products combined in China had the highest sodium level (median 1050 mg/100 g, IQR: 774–1473), followed by the USA, South Africa, Australia, with the lowest levels found in UK (432 mg/100 g, IQR: 236–786) (p<0.001). Similar variations, that is, a twofold to threefold difference of sodium content between the highest and the lowest countries were found among processed meat and fish products separately. Large sodium content variations were also found in certain specific food subcategories across the five countries, as well as across different food subcategories within each country.Conclusion Processed meat and fish products differ greatly in sodium content across different countries and across different food subcategories. This indicates great potential for food producers to reformulate the products in sodium content, as well as for consumers to select less salted food.
Opačić-Galić Vanja, Veljović Đorđe, Nešković Jelena
et al.
Introduction/Objective. Calcium hydroxide (CH) is the medicament of choice in endodontic treatment of internal root resorptions. The aim of the study was to compare the effectiveness of three different techniques for CH removal from simulated internal root resorptions. Methods. Twenty-nine extracted single-root teeth were prepared using NiTi rotary files of BioRaCe system (40/.04) following irrigation. A round diamond drill was used in the making of a symmetrical standardized internal resorptions 6 mm from the apex. Three techniques for CH removal from internal resorptions were tested: modified conventional syringe irrigation (CSI), passive ultrasonic irrigation (PUI), XP-endo Finisher (XP). Resorptive cavities and apical thirds were observed under a stereomicroscope (×45) and scored (from 1 to 5), while representative samples were analysed by a scanning electron microscope. Obtained results were statistically processed by Kruskal–Wallis and Mann–Whitney U-test (p < 0.05). Results. The most efficient system was PUI, with 66.7% of samples rated 1 and 33.3% rated 2. The next one was XP, and the least efficient was CSI, with 33.3% of samples rated 1 (resorptive defect without medicament). There was a statistically significant difference between the PUI and CSI systems (p < 0.05), while there was no difference between the PUI and XP systems. Conclusion. No system completely removed the CH from the simulated internal root resorption cavities. PUI was the most effective system for removing CH. The combination of techniques provides better performance in removing CH paste residues from the canal walls
Little is known about how propofol modulates the spike firing correlation between excitatory and inhibitory cortical neurons in vivo. We performed extracellular unit recordings from rat insular cortical neurons, and classified neurons with high spontaneous firing frequency, bursting, and short spike width as high frequency with bursting neurons (HFB; pseudo fast-spiking GABAergic neurons) and other neurons with low spontaneous firing frequency and no bursting were classified as non-HFB. Intravenous administration of propofol (12 mg/kg) from the caudal vein reduced the firing frequency of HFB, whereas propofol initially increased (within 30 s) and then decreased the firing frequency of non-HFB. Both HFB and non-HFB spontaneous action potential discharge was depressed by propofol with a greater depression seen for HFB. Cross-correlograms and auto-correlograms demonstrated propofol-induced increases in the ratio of the peak, which were mostly observed around 0–10 ms divided to baseline amplitude. The analysis of interspike intervals showed a decrease in spike firing at 20–100 Hz and a relative increase at 8–15 Hz. These results suggest that propofol induces a larger suppression of firing frequency in HFB and an enhancement of synchronized neural activities in the α frequency band in the cerebral cortex (192 words). Keywords: General anesthetics, Insular cortex, Synchronization, GABAergic neuron, Awake
Carrol Gamble, Paula Williamson, William Shaw
et al.
Introduction Cleft palate is among the most common birth abnormalities. The success of primary surgery in the early months of life is crucial for successful feeding, speech, hearing, dental development and facial growth. Over recent decades, age at palatal surgery in infancy has reduced. This has led to palatal closure in one-stage procedures being carried out around the age of 12 months, but in some cases as early as 6 months. The primary objective of the Timing Of Primary Surgery for Cleft Palate (TOPS)trial is to determine whether surgery for cleft palate performed at 6 or 12 months of age is most beneficial for speech outcomes.Methods and analysis Infants with a diagnosis of non-syndromic isolated cleft palate will be randomised to receive standardised primary surgery (Sommerlad technique) for closure of the cleft at either 6 months or 12 months, corrected for gestational age. The primary outcome will be perceived insufficient velopharyngeal function at 5 years of age. Secondary outcomes measured across 12 months, 3 years and 5 years will include growth, safety of the procedure, dentofacial development, speech, hearing level and middle ear function. Video and audio recordings of speech will be collected in a standardised age-appropriate manner and analysed independently by multiple speech and language therapists. The trial aims to recruit and follow-up 300 participants per arm. Data will be analysed according to the intention-to-treat principle using a 5% significance level. All analyses will be prespecified within a full and detailed statistical analysis plan.Ethics and dissemination Ethical approval has been sought in each participating country according to country-specific procedures. Trial results will be presented at conferences, published in peer-reviewed journals and disseminated through relevant patient support groups.Trial registration number NCT00993551; Pre-results.