Clinical Research Directory

Comparative Study of Regional Nerve Blocks in Primary Cleft Palate Repair

This study will evaluate whether adding a suprazygomatic maxillary nerve block to the standard palatal nerve block improves pain control after cleft palate repair surgery in children. Participants will be randomly assigned to receive either the standard palatal block alone or the standard palatal block combined with a suprazygomatic maxillary nerve block. Both techniques use medications commonly used for pain management during surgery. The purpose of this study is to determine whether the addition of the suprazygomatic maxillary nerve block reduces postoperative pain, decreases the need for opioid medications, and improves recovery after cleft palate repair. Researchers will compare pain scores, medication use, recovery outcomes, and any treatment-related complications between the two groups. Information collected from this study may help identify the most effective regional anesthesia approach for children undergoing cleft palate repair and may improve postoperative pain management and patient recovery.

Cleft Lip Scarring After Botox

This study is investigating whether botulinum toxin type A (Botox) can improve scar appearance after cleft lip repair surgery. Cleft lip repair is commonly performed during infancy, but visible scarring can occur as the incision heals. Botox may reduce muscle movement around the surgical site during healing, which could decrease tension on the wound and improve scar formation. In this study, infants undergoing cleft lip repair will be randomly assigned to receive either Botox or a placebo injection at the time of surgery. Researchers will evaluate scar appearance during follow-up visits over the first year after surgery and will monitor participants for any treatment-related side effects. The goal of this study is to determine whether Botox is a safe and effective method for improving scar quality following cleft lip repair.

Evaluation of a Novel Nasal Conformer in Pediatric Patients

This study compares the current commercially available nasal conformer available for use in cleft lip repair and nasal scar release to a novel, anatomically shaped conformer based upon typical nasal airspace shape. This will follow patients using both of these types of splints during the post-operative healing process with one group starting with the standard splint and then moving to the anatomic conformer and the second group beginning with the anatomic and them moving to the standard conformer. This study will evaluate the patient experience and outcomes of the 2 types of conformers, looking at the discomfort, device dislodgements, ease of use and occurrence of complications such as skin irritation and rashes or skin breakdown.

Perioperative Respiratory Adverse Events in Cleft Lip and Palate Surgery: Incidence, Risk Factors, and Clinical Scoring

Cleft lip and palate surgeries present unique anesthetic challenges due to shared airway access with the surgical field, frequent anatomical abnormalities, and a predominantly infant and toddler population. These factors substantially increase the risk of perioperative respiratory adverse events (PRAEs), including laryngospasm, bronchospasm, desaturation, post-extubation stridor, and unanticipated re-intubation. This prospective single-center observational cohort study aims to determine the true incidence of PRAEs in pediatric patients undergoing elective cleft lip and/or palate repair under general anesthesia, and to identify independent predictive risk factors using standardized airway assessment tools including the Han Mask Ventilation Score and the Intubation Difficulty Score (IDS). No interventions beyond routine clinical practice will be applied. All airway management decisions will remain at the discretion of the attending anesthesiologist.

Outcome of Alar Base Support in Unilateral Secondary Cleft Lip and Nasal Deformity Repair With Dermal Roll Flap

Dermal Roll flap for alar base support

Allied Cleft & Craniofacial Quality-Improvement and Research Network (ACCQUIREnet)

The Allied Cleft \& Craniofacial Quality-Improvement and Research Network (ACCQUIREnet) is a group of multidisciplinary cleft teams that have implemented a system for prospective collection of outcomes data, based on the ICHOM Standard Set for the Comprehensive Appraisal of Cleft Care, CLEFT-Q, and other outcomes instruments. Participating cleft teams may analyze clinical and psychosocial outcomes related to care of the child with cleft lip and/or palate (CL/P), compare its performance with those of other cleft centers, and identify opportunities for quality improvement.

Effects of AlignBabyCleft (ABaCleft)

Since the appearance of presurgical infant orthopedic (PSIO) as a treatment for patients with cleft lip and palate ( CLP) , numerous techniques have been described with the aim of aligning the displaced alveolar segments and restoring the position of the lateral cartilage, thus improving the results of primary surgery. Currently, the most used technique in the different protocols is the nasoalveolar molding (NAM) described by Grayson, from which variants and modifications have emerged in order to improve its results and provide greater comfort for both the patient and their caregivers. However, the main drawback of traditional acrylic NAM is the need for sequential addition of acrylic to reduce the size of the indentation. These weekly adjustments consume time and resources for the caregiver and the orthodontist. Likewise, it has been observed that acrylic resin can cause inflammation, irritation and gingival ulceration due to excessive pressure. PSIO treatment in newborns is a complex procedure that could benefit from simplification through digitization, providing accuracy and precision, avoiding risks such as respiratory obstruction and cyanosis that can be produced by taking impressions with alginates or silicones, most of them needing to be performed under general anesthesia. Until now, infant care has been left out of such digitization, despite the fact that the majority of babies who need early orthodontic treatment often suffer from craniofacial disorders. However, in recent years numerous advances have been made in this type of treatment, both in taking records, and in the application of more physiological, lighter and constant forces, providing greater comfort, better acceptance and less pain for the patient . These changes represent a great advance applicable to patients with CLP.

Targeting Surgeons' Decision-Making for Cleft Lip Surgery

Using separate prospective cohorts of patients who have lip revision and lip repair surgery, the objective of this clinical trial is to both qualitatively and quantitatively assess how surgeons integrate the objective measures and visual aids of the Intervention with the systematic subjective assessment in order to determine decisions surgery.

Effect of Different Nasal Stent Designs With Nasoalveolar Molding Appliance

This study is designed to compare 2 different designs of nasal stents in conjunction with nasoalveolar molding appliance regarding the changes in nose and lip esthetics in infants with cleft lip and palate.

Genetics of Reproductive Disorders (Including Kallmann Syndrome) and Cleft Lip and/or Palate

The purpose of this study is to explore the genetic basis of reproductive disorders and cleft lip and/or palate.