Cleft Lip and Palate

Researchers are evaluating a fully digital, facially guided approach to full-mouth rehabilitation for adults with bite difficulties, smile dissatisfaction, and missing mandibular molars. This study focuses on patients with malocclusion and partial or complete tooth loss who need esthetic and functional dental restoration. The goal is to assess how integrated digital planning combining intraoral, facial, and CBCT scans can improve the precision and outcomes of dental rehabilitation. The treatment uses advanced digital planning to create a 3D virtual patient model that guides esthetic design, occlusion, and implant placement. Participants receive conservative anterior rehabilitation with lithium disilicate veneers, zirconia crowns, guided implant placement for missing molars, and temporary anchorage device-assisted intrusion of extruded molars. This fully digital workflow aims for precise restoration positioning, functional occlusion, and esthetic results. During the study, participants will undergo scans, treatments, and follow-up visits as part of the digital workflow. Researchers will measure implant stability 12 months after treatment to evaluate the success of the rehabilitation. Participants are expected to comply with treatment and follow-up protocols, and will be monitored for functional and esthetic outcomes using integrated digital data throughout the study period.

Researchers are evaluating the SureSmile clear aligner medical device in a multicenter clinical study. The study's main goal is to confirm the safety and assess the accuracy of different tooth movements when using these aligners. Additionally, the study compares three different trimline designs: Scalloped, Straight, and Straight Extended, to see how they perform during treatment for dental malocclusion. Participants will receive SureSmile clear aligners customized to fit their mouths, with each group using a different trimline design. The three groups include scalloped trimline, straight trimline, and straight extended trimline (2 mm). All other treatment protocols and materials remain the same across groups. Treatment typically lasts between 6 and 18 months, depending on the predetermined plan. During the study, participants' tooth movement accuracy will be measured at the start and end of aligner treatment. Comfort and pain levels will be recorded every 8 weeks throughout treatment and during a refinement period lasting about 8 to 12 weeks. The study also monitors any adverse events or device issues from the start until around 18 months later, when retainers are delivered. This careful follow-up helps assess safety and treatment outcomes.

Researchers are evaluating skin changes in adult women with moderate-to-severe cheek wrinkles using non-invasive imaging methods. The goal is to study the effects of treatments aimed at improving volume deficiency, skin laxity, and photo-aged skin in the mid-face area. This is an open-label, single-center study sponsored by Galderma R&D involving women aged 45 to 65 years. Participants will receive three treatments of Sculptra injections into the cheeks, spaced four weeks apart. Each treatment involves subdermal injections using a 25 G needle, with up to 18 mL total per session. The injections target the subcutaneous and supraperiosteal regions evenly across both cheeks. The study focuses on monitoring structural skin changes following these biostimulator treatments. During the study, participants will undergo standardized VISIA imaging and optical biopsy imaging at multiple time points: 4, 8, 12, 16, and 20 weeks after baseline. Researchers will assess changes in the midface structure compared to before treatment. Participants must adhere to a skincare regimen provided by the study and allow photographs at each visit. Safety and response will be monitored throughout the study period, which runs until September 2026.

Researchers are investigating the accuracy of using two customized titanium plates compared to four customized titanium plates for transferring the virtual surgical plan in orthognathic surgery cases. The study aims to improve the precision of maxillary repositioning in three dimensions during these surgeries by minimizing the hardware used in fixation. Participants will receive either two or four customized 3D titanium miniplates designed to transfer the virtual plan accurately to the surgical field. The study is randomized and evaluates these two approaches as procedures during orthognathic surgery. During the study, researchers will assess the accuracy of the plan transfer within one week after surgery and measure patient satisfaction at six months. The study involves close monitoring of surgical outcomes and participant feedback over this period, with participants aged 18 to 40 years taking part.

This research aims to evaluate a new advanced wireless skin sensor system designed to monitor vital signs in healthy newborn infants of at least 35 weeks gestational age. The study focuses on assessing the feasibility, safety, and accuracy of this wireless system compared to the standard wired monitoring during the first two hours after birth, especially during unsupervised parental care in the obstetrical center. The goal is to improve early detection and prevention of Sudden Unexpected Postnatal Collapse (SUPC), a rare but serious condition affecting newborns shortly after delivery. Participants will have both the wireless monitoring system and the standard wired system placed on their chest and limb. For vaginal births, the wireless system is placed first, followed by the wired system after 15-20 minutes; for C-section births, the order of placement is randomized. Both monitoring systems remain in place for two hours to continuously record vital signs such as heart rate, respiratory rate, oxygen saturation, and skin temperature. During the study, newborns' vital signs will be recorded and compared between the two systems for up to two hours immediately after delivery. Researchers will evaluate the feasibility by checking for gaps in data and user satisfaction, assess safety through skin and pain scores, and measure accuracy using statistical comparisons. The study also includes monitoring the time between sensor placement and data display. Participation lasts only the initial two-hour period after birth, with monitoring done under real-world conditions in the obstetrical center.

This research aims to develop and validate an artificial intelligence (AI) software to recognize fetal brain structures and distinguish between normal and abnormal brain anatomy during the second trimester ultrasound scan. The study focuses on fetal brain abnormalities, which are challenging to diagnose prenatally. AI technology may improve detection, reduce variability between operators, shorten examination time, and optimize healthcare resources. The study is conducted by multiple fetal medicine centers and targets pregnant women undergoing routine screening for fetal anomalies. The study consists of two phases: a retrospective phase and a prospective phase. In the first phase, researchers collect and analyze ultrasound images taken between 19 and 22 weeks of gestation from various centers to develop and train the AI algorithm with both normal and abnormal fetal brain images. The second phase prospectively tests the AI algorithm in real clinical settings on patients from the participating centers to validate its performance in assessing fetal brain anatomy. Participants are singleton pregnant women between 19 and 22 weeks of pregnancy who undergo ultrasound scans. Researchers will collect clinical, ultrasound, prenatal, and postnatal data, anonymize images, and store them securely for analysis. The primary outcome is validating the AI algorithm over two years. Secondary outcomes include improving reproducibility and reducing examination time within one year. The study involves continuous monitoring and assessment of ultrasound images to support routine fetal brain screening.

Researchers are evaluating a surgical technique called secondary alveolar bone grafting (SABG) for children aged 8 to 15 years with unilateral maxillary alveolar clefts. The goal is to stabilize the upper jaw by reconstructing the alveolar cleft to promote proper growth, tooth eruption, and orthodontic movement. This study assesses the outcomes of a specific SABG approach using retromolar cortical shells for reconstruction. The procedure involves using retromolar cortical shells along with cancellous bone particles to create a three-dimensional reconstruction of the alveolar cleft. This technique is designed to rebuild the bone structure in the affected area. Participants will receive this surgical graft as the main intervention. During the study, researchers will monitor bone healing and stability over a six-month consolidation period. They will evaluate horizontal bone width, vertical bone level, and bone density to measure the success of the graft. Participants will be followed throughout this period to assess the reconstruction outcomes and overall bone health.

Researchers are evaluating the safety and effectiveness of three sedative-analgesic drugs—intramuscular ketamine, intranasal nalbuphine, and intranasal dexmedetomidine—for children aged 6 months to 3 years undergoing suture removal after cleft palate, alveolar ridge, or lip surgery. This prospective, randomized study aims to compare the time to achieve adequate sedation, ease of the surgical procedure as rated by surgeons, and time to discharge readiness. Additional goals include assessing child behavior, response to drug administration, and parental satisfaction. Participants will be randomly assigned to one of three groups: one receiving intramuscular ketamine plus glycopyrrolate to reduce salivation; another receiving intranasal nalbuphine via a mucosal atomizer device; and the third group receiving intranasal dexmedetomidine also via mucosal atomizer. Premedication with midazolam is given 30 minutes before the procedure. If sedation is insufficient, inhaled sevoflurane may be used as rescue medication. The study uses non-invasive monitoring, with intravenous access only in emergencies. Throughout the procedure, vital signs such as heart rate, oxygen saturation, and blood pressure are continuously monitored. Sedation onset, depth, procedure duration, and recovery time are recorded. Researchers will observe potential complications and evaluate sedation quality and child responses at various stages. Parental satisfaction and surgeon ease of procedure are also assessed. The study is expected to provide evidence to improve sedation protocols for minor pediatric surgeries, with participation lasting only the short procedural and recovery period.

Researchers are evaluating the accuracy and effectiveness of patient-specific plates (PSPs) designed through virtual surgical planning (VSP) for correcting a tilted upper jaw (maxillary cant) in people with facial asymmetry. This prospective clinical trial focuses on how well the actual surgery matches the planned virtual surgery and how satisfied participants are with their appearance after the procedure. The study addresses challenges in traditional surgery by using 3D planning and custom devices tailored to each patient's anatomy. Participants will undergo detailed CT scans to create 3D models of their craniofacial structure. Custom titanium plates and cutting guides are designed and manufactured using 3D printing and milling techniques. Surgery involves precise bone cuts guided by these tools to reposition the upper jaw as planned. The study includes a follow-up period of six months to monitor healing and assess outcomes. During the trial, participants will have multiple CT scans to compare the planned surgical corrections with the actual results. Researchers will evaluate the accuracy of bone repositioning by superimposing images taken before and after surgery at intervals of 1 week, 1 month, 3 months, and 6 months. They will also assess aesthetic results and participant satisfaction. Postoperative care and follow-up visits are standardized to ensure consistent monitoring throughout the study period.

Researchers are evaluating the effect of locally administered vitamin D3 combined with a minimally invasive surgical technique called corticision on accelerating orthodontic canine retraction. This prospective clinical study aims to shorten orthodontic treatment time by speeding up tooth movement, which can reduce risks like gum inflammation and tooth decay. The study compares this combined approach to conventional orthodontic treatment in patients aged 13 to 20 years with specific dental conditions. Participants will be randomly assigned to one of two groups: one group will receive local injections of vitamin D3 alongside corticision, a surgical method to stimulate bone remodeling, while the other group will undergo conventional treatment without these interventions. Vitamin D3 injections are given four times during the 12-week canine retraction period at set intervals. Tooth movement and bone density changes will be closely monitored during this time. Patients will be followed over three months with assessments including photographs, dental X-rays, study models, and cone beam computed tomography (CBCT) scans before and after treatment. Researchers will measure the rate and amount of canine movement as well as changes in alveolar bone density. Regular evaluations will ensure treatment progress and patient compliance. The primary outcome is the rate of canine retraction from baseline to three months, with secondary outcomes focusing on bone density changes in the treated area.