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Among infants with isolated cleft palate, whether primary surgery at 6 months of age is more beneficial than surgery at 12 months of age with respect to speech outcomes, hearing outcomes, dentofacial development, and safety is unknown. We randomly assigned infants with nonsyndromic isolated cleft palate, in a 1:1 ratio, to undergo standardized primary surgery at 6 months of age (6-month group) or at 12 months of age (12-month group) for closure of the cleft. Standardized assessments of quality-checked video and audio recordings at 1, 3, and 5 years of age were performed independently by speech and language therapists who were unaware of the trial-group assignments. The primary outcome was velopharyngeal insufficiency at 5 years of age, defined as a velopharyngeal composite summary score of at least 4 (scores range from 0 to 6, with higher scores indicating greater severity). Secondary outcomes included speech development, postoperative complications, hearing sensitivity, dentofacial development, and growth. We randomly assigned 558 infants at 23 centers across Europe and South America to undergo surgery at 6 months of age (281 infants) or at 12 months of age (277 infants). Speech recordings from 235 infants (83.6%) in the 6-month group and 226 (81.6%) in the 12-month group were analyzable. Insufficient velopharyngeal function at 5 years of age was observed in 21 of 235 infants (8.9%) in the 6-month group as compared with 34 of 226 (15.0%) in the 12-month group (risk ratio, 0.59; 95% confidence interval, 0.36 to 0.99; P = 0.04). Postoperative complications were infrequent and similar in the 6-month and 12-month groups. Four serious adverse events were reported (three in the 6-month group and one in the 12-month group) and had resolved at follow-up. Medically fit infants who underwent primary surgery for isolated cleft palate in adequately resourced settings at 6 months of age were less likely to have velopharyngeal insufficiency at the age of 5 years than those who had surgery at 12 months of age. (Funded by the National Institute of Dental and Craniofacial Research; TOPS ClinicalTrials.gov number, NCT00993551.).

IntroductionCleft 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 analysisInfants 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 disseminationEthical 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.

Emergence agitation remains a problem that occurs in pediatric anesthesia. As cleft surgeries constitute one of the most common craniofacial surgeries encountered, majority of the children receive general anesthesia using high dose opioids and inhalation anesthetics and experience emergence agitation. Dexmedetomidine (DEX), an alpha-2 adrenoreceptor agonist possesses anxiolytic, sedative and analgetic properties and have been documented to reduce the incidence of postoperative agitation. Hence, this study aims to compare the incidence of emergence agitation between the use of intravenous DEX versus Sevoflurane (SEVO) anesthesia. This study selected one hundred twenty-one patients ages 3 months to 10 years with ASA 1 and 2 physical status scheduled to undergo elective cleft lip or cleft palate repair with general anesthesia. Before surgery, all patients were assessed preoperatively and subjects were divided into two groups using a computer-generated randomizer with 59 subjects selected as Dexmedetomidine group; and 62 subjects as Sevoflurane group. Extubation time, recovery time and emergence agitation scale were compared between the two groups. This study found no significant difference in the extubation time between DEX and SEVO group (p = 0.317). The recovery time or time to attain full consciousness was statistically longer in the DEX group: 60 minutes as compared to 52 minutes in the SEVO group (p = 0.007). Emergence agitation assessed using Cravero score found that subjects from DEX group had an average Cravero score of 2.5; while SEVO group had an average Cravero score of 3.9 (p = < 0.001). The incidence of agitation was significantly higher in the SEVO group compared to the DEX group: 82% as compared to 10% (p = < 0.001) with an OR of 40.955 CI 95% (14.098-118.9). Dexmedetomidine significantly reduces the incidence of emergence agitation without prolonging extubation time in pediatric patients undergoing cleft lip and cleft palate surgery.

Cleft Lip and Palate (CLP) - a common facial malformation in newborns – is typically corrected by surgical intervention to allow for normal speech development, psychosocial adjustment, and facial attractiveness. The long term treatment outcome can be evaluated after a number of years, possibly in adulthood. We investigated the aesthetics of the nasolabial region by subjective ratings. To compare various surgical approaches we recruited 12 raters to evaluate 429 patients. Expert and lay raters judged photographs from patients, who have completed treatment with one of three different surgical strategies performed in our institution over 50 years. Facial photographs were cropped, presented to the raters in a randomized sequence, and judged by the raters on a 5 point Likert scale. The subjective ratings between the raters revealed a fair to substantial inter-rater reliability. The average ratings of the surgical outcome improved continuously over the investigated 5 decades. Despite possible differences between raters and rater groups this overall result was consistently seen in the gender groups (male/female), or expertise related groups (expert/lay). Our analysis revealed that patients with bilateral CLP scored worse than patients with unilateral CLP when treated in the fifties; more recently treated patients of both groups scored similarly.

ObjectiveThe essential concern of alveolar cleft grafting in patients of cleft lip and palate at the mixed dentition phase is to gain bone within the cleft area that provides closure of the oronasal communication with continuous and stable maxilla for future cleft teeth eruption or implantation. This study aimed to compare the effectiveness of mineralized plasmatic matrix (MPM) versus cancellous bone particles harvested from anterior iliac crest in secondary alveolar cleft grafting.Patients and methodsThis prospective randomized controlled trial was conducted on ten patients with unilateral complete alveolar cleft requiring cleft reconstruction. Patients were randomly divided into two equal groups; group (1) included 5 patients who received particulate cancellous bone derived from anterior iliac crest (control group) and group (2) included 5 patients who received MPM graft prepared from cancellous bone derived from anterior iliac crest (study group). All patients received CBCT preoperatively, immediately postoperatively and after 6 months. On the CBCT, graft’s volume, labio-palatal width, and height were measured and compared.ResultsThe outcome of the studied patients 6 months postoperatively showed that the control group had significant decrease in the graft volume, labio-palatal width, and height compared to the study group.ConclusionMPM allowed for the integration of bone graft particles inside a fibrin network, which offers positional stability of the bone particles, thus preserving their shape with subsequent “in situ” immobilization of the graft components. This conclusion was reflected positively in terms of maintained graft volume, width, and height compared to that of the control group.Clinical relevanceMPM allowed for maintenance of grafted ridge volume, width, and height.

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).

ObjectivesThis study aimed to compare dimensional alterations of dental arches in children with unilateral complete cleft lip and palate before and after different techniques of primary plastic surgeries.Materials and methodsThe sample was divided into two groups: group 1—cheiloplasty by Millard’s technique and one-stage palatoplasty by von Langenbeck’s technique; group 2—cheiloplasty by Millard’s technique and two-stage palatoplasty: anterior palatoplasty by Hans Pichler’s technique and posterior palatoplasty by Sommerlad’s technique. Dental arches were evaluated before (T1), after the first phase (T2), and 1 year after the second phase (T3) of primary surgeries. Linear measurements and palatal area were assessed. To analyze the method’s error, interclass correlation coefficient was applied. ANOVA (followed by Tukey test), dependent, and independent t-test were used (p < 0.05).ResultsAt T1, the intertuberosity distance was statistically greater in G2 (p = 0.004). At T2, the anterior length of the dental arch was statistically greater in G2 (p = 0.025), while the area of the smaller palatal segment (p = 0.001), cleft area (p = 0.014), and total area (p = 0.002) were statistically smaller in G2. At T3, the intertuberosity distance was statistically greater in G2 (p = 0.017).ConclusionThis study suggests that cheiloplasty and one-stage palatoplasty resulted in smaller growth of maxilla than cheiloplasty and two-stage palatoplasty in the linear measurements (T-T’ and I-CC’) and total area of the dental arches.Clinical relevance.Surgical protocols need to be evaluated to verify their effects aiming at improving the clinical practice of the interdisciplinary team, determining new parameters for the rehabilitation of individuals with cleft lip and palate.

Presurgical orthodontic treatment before secondary alveolar bone grafting (SABG) is widely performed for cleft lip/palate patients. However, no randomized controlled trial has been published comparing SABG outcomes in patients with and without, presurgical orthodontic treatment. This randomized, prospective, single-blinded trial was conducted between January 2012 and April 2015 to compare ABG volumes 6 months postoperatively between patients with and without presurgical orthodontic treatment. Twenty-four patients were enrolled and randomized and 22 patients completed follow-up. Patients who had presurgical orthodontics before SABG had significantly improved inclination (p < 0.001) and rotation (p < 0.001) of the central incisor adjacent to the defect, significantly improved ABG fill volume (0.81 ± 0.26 cm 3 at 6 months compared to 0.59 ± 0.22 cm 3 ; p < 0.05) and less residual alveolar bone defect (0.31 ± 0.08 cm 3 at 6 months compared to s 0.55 ± 0.14 cm 3 ; p < 0.001) compared to patients who did not have presurgical orthodontic treatment. In conclusion, orthodontic treatment combined with SABG results in superior bone volume when compared with conventional SABG alone.

Background There is a great challenge to sedation for infants with cleft lip and palate undergoing CT scan, because there is the younger age and no consensus on the type, dosage, and route of drug administration. Objective This study aimed to evaluate the efficacy of intranasal administration of dexmedetomidine combined with midazolam as a sedative option for infants with cleft lip and palate under imaging procedures. Methods Infants scheduled for cleft lip and palate repair surgery were randomly assigned to the IND group (intranasal dexmedetomidine 2 µg/kg alone) and the INDM group (intranasal dexmedetomidine 2 µg/kg combined with midazolam 0.05 mg/kg). The primary outcome was the proportion of infants underwent successful computed tomography (CT) scans under intranasal sedation. The secondary outcomes included onset time and duration of sedation, recovery time, Ramsay sedation scale, hemodynamic parameters during sedation, and adverse events. Data analyses involved the unpaired t-test, the repeated-measures analysis of variance test, and the continuity correction χ2 test. Results One hundred five infants were included in the analysis. The proportion of infants underwent successful CT scans under sedation was significantly greater in the INDM group than in the IND group (47 [95.9%] vs. 45 [80.4%], p  = 0.016). Additionally, the INDM group had a shorter onset time and a longer duration of sedation statistically (12 [8.5, 17] min vs. 16 [12, 20] min, p  = 0.001; 80 [63.6, 92.5] min vs. 68.5 [38, 89] min, p  = 0.014, respectively), and their recovery time was significantly longer (43 [30, 59.5] min vs. 31.5 [20.5, 53.5] min, p  = 0.006). The difference in Ramsay sedation scale values 20 min after administration was statistically significant between the groups. No statistically significant difference was found between the groups in changes in heart rate and respiratory rate. Conclusion Intranasal administration of dexmedetomidine in combination with midazolam resulted in higher sedation success in comparison with sole dexmedetomidine. However, it has a relatively prolonged duration of sedation and recovery time. Trial registration ChiCTR2100049122, Clinical trial first registration date: 21/07/2021.