Cleft Palate

13

Review clinical trials related to Cleft Palate. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

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.

Participants needed: 150
Trial details
Age: 0-3Biological sex: AllType: ObservationalSponsor: Marmara University Pendik Training and Research HospitalUpdated: Jun 16, 2026
Eligibility criteria

Age 0-3 years (infants and toddlers) [+3]

Pre-existing respiratory failure or active tracheostomy [+2]

Status: Recruiting

Etiological Study of Persistent Velopharyngeal Insufficiency in Children With Operated Velopalatine Cleft by Analysis of Velopharyngeal Motor Skills in Static and Dynamic MRI

Velopharyngeal insufficiency is defined as the inability of the soft palate to isolate the nasopharynx from the oropharynx. It is a frequent sequela in patients with a velopalatine cleft despite anatomical restoration of the soft palate by intravelar veloplasty at 6 months. If rehabilitation by a speech therapist is not successful, a pharyngoplasty can be discussed. In the last ten years, MRI was used in dynamic and static way, to analyzed velopharyngeal muscles, in particular Levator Veli Palatini. MRI could be used to identify the etiology of VPI in those patients, and thus allow personalized rehabilitation and surgical management. The aim of this study is to examine the differences in velopharyngeal motricity as well as velar muscles morphology, positioning, and symmetry of children with repaired cleft palate with different degrees of severity of velopharyngeal insufficiency (VPI), and children with labial cleft (noncleft palate anatomy).

Participants needed: 30
Trial details
Age: 7-12Biological sex: AllType: InterventionalSponsor: Centre Hospitalier Universitaire, AmiensUpdated: Jun 15, 2026Locations: 1
Eligibility criteria

Children aged 7 to 12 years with Isolated cleft lip [+5]

Refusal of the parents and/or the patient [+5]

Status: Recruiting

Optimizing Perioperative Analgesia to Lower Pain Following Cleft Palate Surgery

The purpose of this study is to compare the use of short acting opioids (fentanyl/hydromorphone) with long acting opioids (methadone) for pain control following cleft palate surgery in infants and young children.

Participants needed: 60
Trial details
Phase: Phase 4Age: 6-4Biological sex: AllType: InterventionalSponsor: Duke UniversityUpdated: Apr 14, 2026Locations: 1
Eligibility criteria

Age 6 months to 4 years of age [+2]

History of chronic kidney or liver disease [+3]

Status: Not yet recruiting

MRI Assessment of Velopharyngeal Anatomy After Modified Furlow-Buccinator Flap in Late Primary Palate Repair

The goal of this case series study is to learn if magnetic resonance imaging (MRI) can show how well the palate and throat muscles work at rest and during speech after late cleft palate repair. The surgery uses a technique in which the muscle from the cheek is used to close the gap and repair the cleft and therefore improve speech. The study will answer the question of whether this technique will provide better closure and improved speech in the participants who have not received early treatment. The participants will have the surgery and then have MRI scans 6 months after surgery while resting and speaking specific sounds. Complete speech assessments will also be done 6 months after surgery.

Participants needed: 10
Trial details
Age: 5+Biological sex: AllType: InterventionalSponsor: Cairo UniversityUpdated: Apr 7, 2026Locations: 1
Eligibility criteria

Non-syndromic cleft palate (La Veau I-IV) [+2]

Syndromic clefts or associated craniofacial anomalies. [+3]

Status: Recruiting

Nebulized Bupivacaine Analgesia for Cleft Palate Repair

In this study we introduce a potent local anesthetic; bupivacaine 0.5% in 0.5 mg/kg dose by nebulization as a preemptive analgesia to compare efficacy and safety in children with cleft palate repair.

Participants needed: 60
Trial details
Phase: Phase 3Age: 1-7Biological sex: AllType: InterventionalSponsor: Assiut UniversityUpdated: Jan 2, 2026Locations: 1
Eligibility criteria

Children (age 1-7 years) of American Society of Anaesthesiologists physical stat... [+1]

Coronary artery disease [+3]

Status: Not yet recruiting

Early Intervention in Infants With Unrepaired Cleft Palate: Language, Palatal Function, and Articulation.

The goal of this clinical trial is to learn if teaching speech skills to infants with cleft palates, prior to palate repair, will help them to develop speech and language skills. It will also learn about whether the skills are linked to fewer speech sound difficulties when they start school. The main questions it aims to answer are: Do standard, early intervention techniques to promote language development, that are used in children who are late talkers, work in infants with cleft palates? Will infants with cleft palates increase the number of sounds they use after targeted intervention? Can infants attempt to make stop sounds, like b and p, after targeted intervention? Can infants with cleft palate learn new words more quickly when they are used with gestures? Participants will: Participate in a baseline evaluation of speech and language skills, either in person, or via Telehealth. Attend the clinic for twice-weekly visits, for six weeks, to learn techniques to help their infants develop their speech and language skills, in a group setting with other families of infants with cleft palate. Participate in a final evaluation of speech and language skills, either in person, or via Telehealth.

Participants needed: 200
Trial details
Age: 6-12Biological sex: AllType: InterventionalSponsor: Old Dominion UniversityUpdated: Oct 22, 2025Locations: 1
Eligibility criteria

Infants with unrepaired cleft palate (with or without cleft lip) [+1]

Medically fragile status that would preclude participation in this community-bas... [+3]

Status: Recruiting

Effect of Furlow Palatoplasty With Buccal Myomucosal Flap on the Speech Development

About 20 patient will be collected according to the eligibility criteria and grouped into Group I : 10 patients were treated with furlow with buccinators flap Group II : 10 patients were treated with 2 flap palatoplasty All patients will be examined by an expert Phoniatrician by Recording of speech samples in Arabic language for the children in a soundproof room including repeated syllables, sentences with high-pressure sounds and counting from 1 to 10. The records will be analyzed to assess the degree of hypernasality, speech intelligibility and compensatory speech errors

Participants needed: 30
Trial details
Age: 3-5Biological sex: AllType: ObservationalSponsor: Fayoum UniversityUpdated: Jul 28, 2025Locations: 1
Eligibility criteria

3-5 years old childreen with previous treated complete cleft lip and palate, non... [+1]

Patients with syndromic cleft lip. [+5]

Status: Recruiting

QL vs LAI for Palatoplasty

This study will consist of patients ages 6-18 who are undergoing a surgery on the hard or soft palate of the mouth (palatoplasty), with removal of bone from the front of the hip (anterior iliac bone graft harvesting). The patients will be randomized to receive either a unilateral QL block by an anesthesiologist, or local anesthetic infiltration at the surgical incision by the surgeon. The primary aim will be assessing post-operative pain in the first 48 hours after surgery. Secondary outcomes will include pain medication use in the first 48 hours after surgery, block resolution time, and evaluating any complications associated with the QL block or local anesthetic infiltration.

Participants needed: 46
Trial details
Age: 6-18Biological sex: AllType: InterventionalSponsor: Medical University of South CarolinaUpdated: Jul 4, 2025Locations: 1
Eligibility criteria

Patients undergoing palatoplasty with autologous bone graft from the anterior il... [+3]

overlying infection skin at the block needle insertion site [+6]

Status: Not yet recruiting

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.

Participants needed: 30
Trial details
Age: 7-1Biological sex: AllType: InterventionalSponsor: Universidad Complutense de MadridUpdated: Apr 25, 2025
Eligibility criteria

All patients born at term, without any syndrome associated with CLP, aged betwee... [+4]

Caregivers who are not fluent in the Spanish language will be excluded in order... [+3]

Status: Recruiting

Neural Network to Calculate Morphology of the Cleft Palate to Reduce Cleft Lip and Palate Treatment Burden.

This study is to develop a neural network to compute palatal three dimensional (3D) geometry by using routinely taken intraoral/palatal photographs and palatal casts of infants with cleft lip and palate deformity for reducing cleft lip and palate treatment burden. Data of palatal casts and palatal images of cleft patients routinely treated at the University Hospital Basel will be analyzed.The collection of large data helps in developing a neural network that will allow the computation of the 3D geometry from single photographs.

Participants needed: 450
Trial details
Biological sex: AllType: ObservationalSponsor: University Hospital, Basel, SwitzerlandUpdated: Mar 24, 2025Locations: 1
Eligibility criteria

Patients with cleft lip and palate malformation with available routinely perform...

Existence of a documented rejection

Status: Not yet recruiting

Role of Plasma Rich Growth Factor in Repair Primary Cleft Palate

Does the plasma-rich growth factor (PRGF) with primary cleft palate repair accelerate wound healing and prevent post-operative oronasal fistula occurrence?

Participants needed: 36
Trial details
Age: 6-18Biological sex: AllType: InterventionalSponsor: Cairo UniversityUpdated: Mar 21, 2025Locations: 1
Eligibility criteria

systemically healthy patients (American Society of Anesthesiologists -ASA I and... [+2]

Patients with recurrent palatal fistula [+3]

Status: Not yet recruiting

Velopharyngeal Insufficiency Evaluation Post Cleft Palate Repair. Furlow With Buccinator Myomucosal Flap Versus Two Flap Palatoplasty

Cleft palate is one of the most common congenital abnormalities of the orofacial region throughout the world. This condition can cause facial deformity, feeding problems, frequent middle ear infections, dental defects, speech abnormalities and emotional problems . Early surgical repair of this congenital anomaly prevents the psychological and functional problems associated with the deformity . Patients may develop various complications after primary palatoplasty including palatal fistula and velopharyngeal insufficiency (VPI) which are relatively common . The main goal of cleft palate repair is to achieve normal speech and adequate velopharyngeal function with minimal effect on facial growth. The primary objective in the surgical repair of a cleft palate is the development of normal speech. Speech quality remains the most important standard for assessing clinical outcomes and the success of surgical procedures. Many surgical techniques for palate correction have been described determining the most effective technique for the surgical repair of palatal clefts continues to cause controversy . The incidence of VPI post cleft palate repair is 20-30% of patients . If there is significant velopharyngeal dysfunction during normal speech development, many children learn to compensate for the lack of intraoral pressure. They produce a hoarse voice because of vocal fold adduction and sudden release. Compared with the adductor vocal fold palsy .

Participants needed: 50
Trial details
Age: 3+Biological sex: AllType: InterventionalSponsor: Sohag UniversityUpdated: Jun 27, 2024Locations: 1
Eligibility criteria

•children more than 3 years old [+3]