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Cleft Lip clinical trials

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NCT ID: NCT06451276 Not yet recruiting - Clinical trials for Cleft Lip and Palate

The Effectiveness of Adhesive Versus Conventional Nasoalveolar Molding on Children With Unilateral Cleft Lip and Palate

Start date: July 20, 2024
Phase: N/A
Study type: Interventional

The present study will compare the effectiveness of adhesive nasoalveolar molding (GS-NAM) and conventional nasoalveolar molding on the alveolar ridge, nasal, and labial growth in children with unilateral cleft lip and palate. objectives: - 1. Evaluation of the anatomical position of the greater and lesser segments of the maxilla related to a stable midline anatomical point. 2. Evaluation of the nasal symmetry.

NCT ID: NCT06411444 Not yet recruiting - Clinical trials for Cleft Lip and Palate

Effect of Different Nasal Stent Designs With Nasoalveolar Molding Appliance

Start date: May 15, 2024
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT06381713 Not yet recruiting - Clinical trials for Cleft Lip and Palate

Effect and Cost-utility of of High Intensity vs. Low Intensity Speech Intervention in Children With Cleft Palate

Start date: August 2024
Phase: N/A
Study type: Interventional

Achieving speech that is understandable and acceptable to others is the key outcome in cleft treatment. Therefore, speech therapy provided by a speech-language pathologist is necessary. This intervention is traditionally provided twice per week for 30 minutes for months or even years by first-line speech-language pathologists. Unfortunately, this low intensity intervention is based on a historical context rather than scientific evidence. This means that current speech therapy knows several shortcomings including poor outcomes, treatment fatigue and high costs related to year-long therapy. Because of these issues, the use of high intensity speech intervention is proposed. Even though solid proof-of-concepts exist for this model, it has not yet found its way into clinical practice. Before this intensity can be implemented and utilized in clinical practice, the effect of this novel program on a larger societal scale must be determined. This project will compare the effect of high intensity and low intensity speech intervention in children with a cleft palate in terms of speech, quality of life, and cost-utility as provided by first-line speech-language pathologists by conducting a large-scale randomized controlled trial. The final goal is to utilize this program in clinical practice and to create awareness of the benefits for children with a cleft palate among stakeholders.

NCT ID: NCT06292234 Not yet recruiting - Clinical trials for Cleft Lip and Palate

Patient Specific Implant Versus Miniplates for Advancement of Hypoplastic Maxilla

Start date: May 1, 2024
Phase: N/A
Study type: Interventional

Distraction osteogenesis is the treatment of choice in management of severe maxillary anteroposterior deficiency allowing for a progressive bone generation and simultaneous expansion of the surrounding scarred soft tissue & better long-term stability & less relapse rate.

NCT ID: NCT06211205 Not yet recruiting - Clinical trials for Cleft Lip and Palate

Effectiveness of a Customized 3D Printed Nostril Retainer Combined With Taping Vs.Taping Only on Enhancing the Nasolabial Esthetics and Maxillary Arch Dimensions in Infants With Unilateral Complete Cleft Lip and Palate.

Start date: January 30, 2024
Phase: N/A
Study type: Interventional

Lip taping was proven as simple, handy technique of PSIO for alveolar molding yielding enhanced maxillary arch dimensions in UCCLP infants. The approach behind this study is to combine this simple step with a digitally designed 3D printed customized nasal molding device to enhance the naslolabial esthetics and maxillary arch dimensions in infants with unilateral complete cleft lip and palate, employing full digital workflow.

NCT ID: NCT06166238 Not yet recruiting - Clinical trials for Cleft Lip, Unilateral

Comparative Study Between Millard and Tennison Randall Techniques in Complete and Incomplete Cleft Lip Repair.

Start date: December 1, 2024
Phase:
Study type: Observational

"the investigators will compare the quantitative and qualitative (functional and aesthetic outcomes) of these two surgical approaches for repair of the unilateral cleft lip using an evaluation protocol developed many years ago by the research council of Operation Smile, a non- profit organization based in Virginia Beach, USA. Operation Smile delivers charity management of cleft lip and palate cases in many different developing countries around the world. Under this protocol, a dual rating system has been developed with two scores: one preoperative score concerning the severity of cleft and one score for the postoperative results.

NCT ID: NCT05940389 Not yet recruiting - Clinical trials for Unilateral Cleft Lip

Nasolabial Soft Tissue Esthetics and Maxillary Changes in Unilateral Cleft Lip and Palate Using PreSurgical Infant Orthopedics With Different Approaches

PSIO
Start date: August 1, 2023
Phase: N/A
Study type: Interventional

The nasal deformity is an abnormality in the appearance and structure of the nose in cleft patients having unilateral cleft lip and palate (UCLP). It involves the displacement of the lower lateral nasal cartilage, oblique and short columella, depressed dome, overhanging nostril apex, and deviated septum. Difficulty in breathing and smelling are the main problems of this deformity. Rhinoplasty for CLP patients is very complicated due to the complex nature of this type of deformity, especially in wide and bilateral cleft patients it is quite challenging.

NCT ID: NCT05830006 Not yet recruiting - Cleft Lip and Nose Clinical Trials

Indications and Evaluation of Microfat Grafting in Cleft Lip Nasal Deformities

Start date: May 1, 2025
Phase: N/A
Study type: Interventional

Aim of the work: The study will be conducted to investigate the efficacy of microfat graftinig in cleft lip nasal deformities especially in young patients and those adults who don't need major correction after rhinoplasty.

NCT ID: NCT05790044 Not yet recruiting - Postoperative Pain Clinical Trials

Clonidine for Infra-orbital Nerve Block During Pediatric Cleft Lip Revision Surgeries

Start date: October 1, 2023
Phase: N/A
Study type: Interventional

Pain in children is usually an undertreated entity. Undertreating perioperative pain could lead to various metabolic, physiologic, and neurophysiological responses. The usual means of management i.e., opioids may increase the incidence of respiratory depression in this age group. Adequate postoperative analgesia in children is a vital part of perioperative care. Good pain relief minimizes oxygen requirement, reduces cardio-respiratory demands, and promotes early ambulation and recovery. Regional block given preoperatively in combination with general anesthesia provides good preemptive analgesia. It is associated with hemodynamic stability, rapid and complete recovery, and reduced analgesic requirement in postoperative period. Type of the study: A prospective randomized controlled double-blind study.

NCT ID: NCT05357092 Not yet recruiting - Cleft Palate Clinical Trials

Effects of AlignBabyCleft (ABaCleft)

(ABaCleft)
Start date: November 2022
Phase: N/A
Study type: Interventional

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.