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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.

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.

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.

SummaryTuberosity grafts had a greater percentage of lamina propria and lower percentage of submucosa when compared to lateral palate grafts.ObjectiveThe study aims to understand the differences in the structural composition of soft tissue autografts harvested from the lateral palate or the tuberosity.Material and methodsPatients were randomly allocated to receive autografts harvested either from palatal or tuberosity sites to augment horizontal volume deficiencies around single-tooth implants. Tissue biopsies were analyzed for histological and histo-morphometric analysis. Picro-sirius red stain was used to evaluate collagen 1 and 3. Also, immuno-histochemical analysis was performed against MMP1, MMP2, cytokeratin-10, cytokeratin-13, and lysine hydroxylase-2.ResultsTwenty specimens were harvested from 9 subjects in the lateral palate group (PG) and 11 subjects in the tuberosity group (TG). The percentage of lamina propria represented 51.08% in the PG group and 72.79% in the TG group, while the area of submucosa was minimal in the TG group representing 4.89% of the total sample vs 25.75% in the PG. The total area of COL-1 and 3 in the TG was 1.19 ± 0.57 and 0.72 ± 0.44 mm2, respectively, while in the PG, the corresponding values were 1.4 ± 0.7 and 1.04 ± 0.5 mm2. The immuno-histochemical analysis generally showed a higher expression of LLH-2, MMP2, CYT-10, and CYT-13 in the TG when compared with the PG.ConclusionTuberosity grafts had a greater percentage of lamina propria and lower percentage of submucosa. The collagen content in the lamina propria was similar for both groups while the immuno-histochemical profile showed differences in the antibody expression of the epithelial cells.Clinical relevanceTuberosity grafts had more lamina propria and less submocusa, which may be beneficial for volume augmentation.

Objectives To evaluate treatment time and patient perception of two surgical methods to expose a palatally displaced canine (PDC) into the oral cavity. Material and Methods A total of 30 consecutive patients between 11 and 18 years, with maxillary displaced canines were recruited. After gaining informed consent from the patients and custodians, the patients were randomized into two groups by an independent person. Both groups received a chain attached to the crown of the canine: in group A (control group) the chain was placed under the mucoperiosteal flap to an incision on the alveolar crest and in group B (test group), the chain penetrated the mucoperiosteal flap inferiorly to the crown of the canine. Outcome measures where time to expose the PDC into the oral cavity and the patient's experience of pain and discomfort during the treatment. Results Twenty‐six patients full‐filled the trial, mean age was 12.9 years, (SD 1.6 years). The time to expose the canines for the control group was 11.9 months (SD 6.5) and for the test group 6.7 months (SD 3.2) The conventional method showed less pain on the day of surgery. Conclusion The method used in the test group resulted in a 5‐month shorter time to expose the canine compared to the control group, and higher pain level on the day of surgery. For generalizability of the results, larger studies are needed.

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.

ObjectiveThis study aims to evaluate the effects of topical hyaluronic acid (HA), hypochlorous acid (HOCl), and flurbiprofen on postoperative morbidity of palatal donor sites after free gingival graft (FGG) surgery.Materials and methodsSixty patients requiring FGG were randomly assigned into four groups: control, HA gel (600 mg/100 g high molecular weight hyaluronic acid), HOCl spray (170–200 ppm, ph7.1), flurbiprofen spray (0.075gr flurbiprofen). Topical agents were applied for 14 days, according to groups. Patients were followed for 28 days. Palatal healing was assessed with the Laundry wound healing index (WHI). Complete epithelization (CE) was evaluated with photographs and H2O2 bubbling. Pain, burning sensation, chewing efficacy, and tissue color match (CM) were evaluated using a visual analog scale (VAS). Postoperative analgesic consumption and delayed bleeding (DB) were also recorded.ResultsHA provided better WHI values on the 7th, 14th, and 21st days compared to the other groups, respectively (p < 0.05). CE was formed on the 21st day in the HA group but on the 28th day in the other groups. HOCl and flurbiprofen groups were not different from the control group or each other in terms of WHI. HOCl had the lowest VAS scores of all time periods. DB was not observed in any group. Significantly fewer analgesics were taken in the topical agent-applied groups compared to the control group.ConclusionsHA exhibits a positive impact on the epithelization of palatal wound healing and color matching. HOCl and flurbiprofen provided less pain; however, they might have negative effects on palatal wound healing.Clinical relevanceAs a result of obtaining free gingival grafts from palatal tissue for mucogingival surgical procedures, secondary wound healing of the donor area occurs. This wound in the palatal region can cause discomfort and pain every time patients use their mouths. The use of HA can reduce postoperative complications by accelerating wound healing and reducing pain. The topical use of flurbiprofen and HOCl can reduce patients’ pain.

Objectives Platelet concentrates are biomaterials with significant potential in tissue regeneration, functioning as scaffolds with greater leukocyte inclusion and a flexible fibrin mesh. However these concentrates have different preparation methods and biological properties. The objective of this clinical investigation was to evaluate the effects of utilizing platelet-rich fibrin (PRF) materials (L-PRF and A-PRF) as a palatal bandage following free gingival graft (FGG) on patients’ morbidity and oral health-related quality of life. Materials and methods Thirty-nine participants received FGG to promote keratinized tissue and treat gingival recession. Participants were randomly assigned to L-PRF, A-PRF, and control groups, with 13 participants in each. They used a visual analog scale (VAS) to rate their pain, analgesic medication use, dietary changes, discomfort, and bleeding at 1–7 days, 14 days and 1 month during the healing process. Patients’ quality of life was assessed using the Oral Health Impact Profile (OHIP-14) at baseline, 1–7 days, 14 days, 1 month, and 6 months. Results There was no difference in anxiety levels between the all groups. ( p  > 0.05). The control group had higher OHIP-14 total scores than the other groups, but the differences were not statistically significant, especially in the first seven days ( p  > 0.05). In addition, the PRF groups showed an improvement in quality of life after 14 days, 1 month, and 6 months ( p  < 0.05). Patients’ pain and suffering decreased with healing. The control group took more postoperative analgesics than PRF groups. In addition, there was a significant decrease in patient complaints about medicine intake, bleeding, pain, perceived sensitivity, and dietary modifications in all groups during follow-up. Conclusions PRF palatal bandages may improve patient’s quality of life, donor site healing, postoperative pain and morbidity. Clinical relevance This study found that preserving the palate in FGG and employing PRF materials that speed palate healing reduce discomfort and morbidity.

To validate and refine the existing understanding of the effectiveness of modified Z-plasty in cleft palate patients by comparing postoperative velopharyngeal function with that of healthy non-cleft individuals using MRI. The study involved six adults one year after modified Z-plasty and fourteen adults with healthy palates. MRI was used to assess the levator veli palatini (LVP) muscle and velopharyngeal structures during rest and phonation, including measurements of soft palate length and thickness. Patients post-modified Z-plasty demonstrated restored LVP muscle trajectory and contractility, yet differences in velopharyngeal dimensions persisted compared to the control group. MRI is a valuable tool for assessing velopharyngeal function. Modified Z-plasty can improve, but not fully normalize, velopharyngeal structures and function in cleft palate patients. These findings provide a reference for future optimization of surgical techniques and rehabilitation strategies in cleft palate repair.