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Cleft Lip clinical trials

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NCT ID: NCT05796336 Recruiting - Clinical trials for Cleft Lip and Palate

Two Methods of Lip Taping as a Presurgical Orthopedic Appliance

Start date: January 12, 2023
Phase: N/A
Study type: Interventional

A randomized clinical trial to compare the effectiveness of two methods of lip taping as a presurgical orthopedic appliances on maxillary arch dimensions in infants with bilateral cleft lip and palate.

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: NCT05779527 Recruiting - Parenting Clinical Trials

Mindful Parenting - A Single Case Experimental Design Study

Start date: January 3, 2023
Phase: N/A
Study type: Interventional

Some parents of children living with a visible difference can experience heightened stress due to the associated challenges of this. Parent's views of the child's visible difference and their responses to the child are important. Mindful parenting approaches have been found to reduce stress or distress for parents of children with disabilities, physical health problems and skin conditions. This study will be completed with a small number of participants (around six to 12). Participants will be parents or carers of a child living with a visible difference aged four to 16 years, who are experiencing stress. Parents or carers will complete an online mindful parenting intervention (called Two Hearts) including video content, audio files and a workbook, over six weeks. Over the twelve-week study period participants will also provide the following information which will be compared over time: - Complete four group support sessions during the intervention via videoconferencing - Complete questionnaires at four timepoints - Provide information about their use of the intervention materials and home practice weekly - Answer two questions daily via text message about parenting stress levels We hope to learn about the initial effects of the mindful parenting programme for parents or carers of children living with a visible difference. We also hope to learn whether parents or carers find completing an online programme possible and practical. Finally, we hope to learn what parents' or carers' views are of the online programme and whether this type of intervention in online format would be helpful for other parents or carers.

NCT ID: NCT05775679 Recruiting - Clinical trials for Cleft Lip and Palate

Test-Retest Reliability, Responsiveness and Interpretability of CLEFT-Q

CLEFT-QSwePsyc
Start date: February 15, 2022
Phase:
Study type: Observational [Patient Registry]

The goal of this observational study is to test the questionnaire CLEFT-Q in a population of patients with cleft lip and/or palate. The main questions it aims to answer are: 1. Are CLEFT-Q scores reliable over time? 2. Can CLEFT-Q detect change following surgical treatment intervention? 3. What is the norm for CLEFT-Q within a control population who do not have cleft lip and/or palate? 4. What is the Minimal Clinically Important Change of CLEFT-Q in different subpopulations of cleft lip and/or palate? 5. Do changes in CLEFT-Q scores correlate with changes in objective outcomes following a surgical intervention? 6. What are the main expectations that patients express before a surgical intervention? 7. How do patients perceive that the results after surgical interventions meet their expectations? 8. Do patients express concepts of importance postoperatively that are not examined by CLEFT-Q? 9. How do healthcare professionals perceive that the use of CLEFT-Q affects clinical decisions and processes? Participants will 1. Fill out the questionnaire CLEFT-Q twice with a two-week space. 2. Before and 1 year after an operation. 3. Be interviewed about their experiences related to an operation or using CLEFT-Q. Researchers will compare results from the cleft lip and palate population to see if there is a difference between them and a population without cleft lip and palate.

NCT ID: NCT05748340 Completed - Cleft Lip Clinical Trials

Unilateral Cleft Lip Repair : Modified Millard and Mishra Technique

Start date: April 1, 2021
Phase: N/A
Study type: Interventional

Our study findings show that vertical lip length and philtral lip height significantly longer in Millard group than Mishra group in immediate postoperative assessment and nasal width was significantly wider in Mishra group than Millard in 3-month postoperative assessment, This may be attributed to that Mishra group deformity was more severe. The lip shape, the vermilion shape was better in Millard technique than Mishra technique, however, this was statistically insignificant The scar shape was less evident in Mishra technique than Millard technique. But this was also statistically insignificant. However, no major difference in the overall results between the Mishra and Millard rotationadvancement repairs. Thus, either technique could be used for unilateral clefts, as the goal of cleft lip repair is making a symmetrical lip with minimal scar restoring the normal appearance of the face and functional anatomy Anthropometric Measurement of surgical outcome evaluates the surgical technique used and helps to compare between cleft and non-cleft side showing the degree of deformity and we used Subjective assessment to analyse facial aesthetics and appearance impairment as the harmony of a person's face is as Important as measurements, so they should be used together in our opinion.

NCT ID: NCT05730946 Completed - Clinical trials for Cleft Lip and Palate

Challenges and Concerns Faced by Parents of Children With Cleft Lip and/or Palate

Start date: July 7, 2022
Phase:
Study type: Observational

Cleft lip and/or palate (CLP) are the most common oro-facial congenital anomalies. These anomalies have an impact on feeding, speech and speech development, facial aesthetics & oral health, all of which are factors that heavily impact the quality of life of CLP patients. CLP also has an effect on the families' social and psychological health. Qualitative research helps understand the perspectives of the participants by exploring the psycho-social aspects of care. Phenomenological approach is a qualitative research method that aims to borrow participants' lived experiences to better understand a specific phenomenon. Currently, there is no clear understanding of the fears, anxieties, and challenges faced by parents of CLP patients in Egypt.

NCT ID: NCT05624151 Completed - Analgesia Clinical Trials

Dexmedetomidine Versus Magnesium Sulphate Added to Bupivacaine in Infraorbital Nerve Block for Perioperative Analgesia in Paediatric Patients for Cleft Lip Surgery

Start date: November 25, 2022
Phase: Phase 3
Study type: Interventional

Regional analgesia is considered the cornerstone for postoperative analgesia in paediatric patients. One of the most common birth defects which require surgical intervention early in life is the cleft lip. Infraorbital nerve block (IONB) has been used for postoperative analgesia in this delicate and sensitive area. As the assessment of pain may be very challenging especially in young children, the local anaesthetics administration can be a safe alternative to opioids.[2] However, the regional block after a single dose of local anaesthetic is of limited duration and efficacy. Hence, the coadministration of adjuvants with local anaesthetics may be helpful for potentiation of analgesic effect. Infraorbital nerve block is a well-recognized regional anaesthetic technique which can provide intraoperative and postoperative pain relief in nasal endoscopic surgery and in some types of oral and dental surgery including cleft lip repair . The block may also be used to help diagnose neuralgia arising from the second division of the trigeminal nerve. The technique for infraorbital nerve blockade is most performed as it exits the infraorbital foramen just below the inferior orbital rim.Dexmedetomidine (DE) is a potent α2 adrenoreceptor agonist and it is highly selective for α2 adrenoreceptor seven times more than clonidine. Many studies documented a prolonged duration and rapid onset of sensory block with the perineural injection of DE. Dexmedetomidine has been introduced as an adjuvant to local anaesthetics in both neuroaxial and peripheral nerve blocks. [9, 10] perineural dexmedetomidine has shown to prolong the duration of postoperative analgesia in addition to reducing the opioid consumption. The exact mechanism of peripheral nerve block produced by α2 adrenoreceptor agonists includes central analgesia, anti-inflammatory effect.Another suggested mechanism is that DE may exert its action through blocking the hyperpolarization-activated cation current after the transient sodium influx. The effect of magnesium was first recognized for the treatment of arrhythmia and preeclampsia, and its effect on anaesthesia and analgesia has recently been recognized. Magnesium sulphate has also been used as an adjunct to anaesthesia in recent years. It is also an effective analgesic agent for perioperative pain. Research have also reported that the intraoperative use of magnesium is characterized by a reduced use of anaesthetics and muscle relaxants. Furthermore, opioid use, postoperative nausea and vomiting, hypertension, and shivering have met a decreased trend with the use of magnesium sulphate. In a study performed by (El-Emam and El motlb) in 2019 they compared the efficacy of dexamethasone versus dexmedetomidine as an adjuvant to bupivacaine in ultrasound guided infraorbital nerve block in paediatric patients scheduled for cleft lip repair. they noticed that dexmedetomidine produced a more prolonged duration of analgesia and a lower pain score and increased sedation than produced by dexamethasone. Also, they found that Both dexamethasone and dexmedetomidine were tolerable with no significant difference regarding the incidence of postoperative nausea and vomiting or intraoperative hemodynamic changes.Aim of the work: The purpose of this randomized controlled double-blind study is to compare the efficacy of Dexmedetomidine or Magnesium sulphate as adjuvants for bupivacaine in infraorbital nerve block in paediatric patients scheduled for cleft lip repair.

NCT ID: NCT05573295 Recruiting - Clinical trials for Cleft Lip and Palate

Dental Age Estimation by Different Methods in Patients With Cleft Lip and Palate

Start date: March 1, 2022
Phase:
Study type: Observational

The aim of this study is to investigate whether there is a significant difference in dental age between children with CLP and healthy controls using the Willems method, Cameriere European formula and London Atlas. It is aimed to create a new formula if there is a significant difference in dental age between children with CLP and healthy controls.

NCT ID: NCT05559281 Completed - Cleft Lip Clinical Trials

Botulinum Toxin Injection in Reducing Lip Scar Following Cleft Lip Repair

Start date: July 1, 2021
Phase: N/A
Study type: Interventional

A cleft lip is a congenital defect resulting from failing to merge developmental processes in the Orofacial region. One of the most common complications surgeons fear after cleft lip repair is a hypertrophic scar. A cleft scar negatively affects a patient's appearance, psychology, and function. Several techniques have been proposed to improve lip scars such as steroid therapy, laser therapy, and silica gel. Despite such efforts, the results were still unsatisfactory. Botulinum Toxin injections may provide a more reliable method

NCT ID: NCT05535530 Completed - Clinical trials for Cleft Lip and Palate

The Effect of a Newly Designed Presurgical Orthopedic Appliance

Start date: January 1, 2021
Phase: N/A
Study type: Interventional

A randomized clinical trial to compare the effectiveness of newly designed active type of presurgical orthopedic appliances on maxillary arch dimensions in infants with bilateral cleft lip and palate.