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Cleft Lip clinical trials

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NCT ID: NCT06408337 Recruiting - Clinical trials for Cleft Lip and Palate

Phase I-IIa, to Evaluate the Safety, Feasibility, and Efficacy of the Use of BIOCLEFT in the Treatment of Cleft Palate.

Start date: April 17, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

Phase I/II, controlled, open-label, randomized, single site clinical trial to assess the safety and feasibility, as well as hint efficacy evidence of a bioengineered palate mucosa substitute on nanostructured fibrin-agarose scaffolds with autologous mucosa tissue-specific cells (culture-expanded fibroblasts and keratinocytes), for tissue replacement and repair of donor area after the reconstruction of palate cleft defects (staphylorraphy), in comparison with standard care for donor mucosa.

NCT ID: NCT06127953 Recruiting - Clinical trials for Unilateral Cleft Lip

Intermediate Cleft Rhinoplasty in Unilateral Cleft Lip Patients: Approaches and Outcomes

Start date: October 23, 2023
Phase: N/A
Study type: Interventional

This is a prospective study of 20 patients with unilateral cleft lip nasal deformity. The technique to be performed is open approach intermediate rhinoplasty using a hybrid technique combining Potter, Dibbell, and Tajima methods as needed (Potter 1954, Tajima and Maruyama 1977, Dibbell 1982). Lip revision will be performed with the intermediate cleft rhinoplasty according to the lip deformity if needed. Aim of the work is To propose an algorithmic approach for management of unilateral cleft lip nasal deformity using hybrid techniques of intermediate cleft rhinoplasty and to assess the aesthetic and functional outcomes. All the regulations of the ethical committee of the faculty of medicine in Sohag University will be followed. Each patient will have a private file with a non-disclosure policy at data presentation where all presented data do not contain any personal information specifying the identity of any of the patients. Informed written consent will be taken from all patients in the study. Regarding patients' assessment, the following items will be fulfilled: Full medical and operative history. Complete physical examination. Nasal examination, including nasal analysis, anterior rhinoscopy, Cottle maneuver, modified Cottle maneuver, and possibly endoscopic examination to fully assess any functional problems. Routine laboratory investigations Standard preoperative photographs (frontal, lateral and basal). Surgery follow up will be at 1 week ,1 month, 3 months, 6 months and 1 year and postoperative photographs will be taken.

NCT ID: NCT06122805 Recruiting - Gingivitis Clinical Trials

Effectiveness of Dual Light Electric Toothbrush vs. Manual Toothbrush in Orthodontic Patients Undergoing Oral Surgery

Start date: March 11, 2024
Phase: N/A
Study type: Interventional

The study is a randomized clinical trial to compare the effectiveness of a dual light ultrasonic toothbrush on periodontal health in orthodontic patients undergoing surgery. Patients with cleft lip and palate undergo bone graft and orthognathic surgery. The study will compare the periodontal outcomes in patients who use these toothbrushes during the post-surgical period.

NCT ID: NCT06105099 Recruiting - Clinical trials for Cleft Lip and Palate

Effect of Performance-specific Cleft Speech Intervention and Long-term Learning in Children With a Cleft Palate

Start date: October 1, 2022
Phase: N/A
Study type: Interventional

Speech therapy in children with a palate deals with two scientific challenges that will be addressed in this project. The first challenge is selecting the best speech approach for a child with a specific cleft speech characteristic (CSC). Many speech therapists use a 'one-size-fits-all' approach to treat compensatory CSCs resulting in poor short- and long-term speech outcomes. To increase the effectiveness and quality of cleft speech care, it is necessary to find the best match between a specific therapy and a given type of CSC. Therefore, this proposal will compare the effect of 3 different speech approaches on the speech and quality of life in Dutch speaking children with different types of CSCs. The second challenge is selecting the best speech approach to enhance long-term learning and transfer of newly established speech skills to untrained consonants. To date, research mainly focused on immediate therapy effects. It is unknown if permanent speech changes occur. Hence, this project will also investigate the short-term and long-term learning effects (retention and transfer) of the different speech approaches from the first objective. This proposal will improve evidence-based and patient-tailored cleft speech therapy.

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: 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: 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: NCT05467527 Recruiting - Clinical trials for Autism Spectrum Disorder

PACT Programme for Parents of Children With SHCN

Start date: June 27, 2022
Phase: N/A
Study type: Interventional

This randomised controlled trial aims to determine the efficacy of a 12-week, smartphone-based Prosocial-orientated Acceptance and Commitment Training (PACT) programme plus age-appropriate positive parenting advice on the psychological flexibility, prosociality, parenting competence and family functioning with parents of children with special health care needs as well as the mental well-being of parent-child dyads over 12 months follow-up.

NCT ID: NCT05454670 Recruiting - Cleft Palate Clinical Trials

The Effect of Collagen Matrix Graft on Postoperative Palatal Fistula Formation After Cleft Palate Repair

Start date: August 10, 2022
Phase: N/A
Study type: Interventional

Palatal fistulas are a major burden to surgeons and patients in the management of cleft palate. Their high rate of occurrence and recurrence makes them particularly challenging even to the highly skilled surgeon. Prevention of postoperative palatal fistula is therefore of paramount importance. Closure of the nasal mucosa under tension has been proposed as a major cause of palatal fistula formation. However, depending on the presentation of the cleft palate, it may be impossible to achieve surgical closure with minimal tension. Till date, there is no universally acceptable method of preventing palatal fistula formation following cleft palate repair. And although the use of pre-surgical appliances such as Latham appliance and the use of local and distant tissues to achieve two layer closure have been proposed, the use of a superpositional collagen graft may also be used to achieve closure of the nasal mucosa with minimal or no tension during cleft palate repair. Collagen grafts have the added advantage of being more patient friendly compared to the Latham appliance which requires an initial surgery for appliance insertion before surgical cleft palate repair. They are also less technique sensitive compared to the use of local and distant tissues. The investigators therefore aim to provide high level scientific evidence of the effectiveness of collagen graft in the prevention of postoperative palatal fistula.