Cleft palate is a birth defect where the roof of the mouth doesn't fully close during fetal development, affecting about 1 in 1,600 babies. Surgical repair is standard, typically done between 9 and 18 months of age. Research now focuses on improving surgical techniques, reducing complications, and understanding genetic causes to potentially prevent clefts.
What's actually going on in research
Trials are testing new surgical approaches to improve speech outcomes and reduce the need for repeat operations, evaluating timing of repair, and studying bone grafting techniques for the jaw. Researchers are also studying folic acid supplementation during pregnancy and genetic counseling for families with cleft history.
Speech outcomes
Studies compare different surgical techniques to see which produces the clearest speech with the least velopharyngeal insufficiency. Some trials test speech therapy approaches tailored to children with repaired clefts.
Prevention research
Large studies are tracking whether higher doses of folic acid during pregnancy reduce cleft risk in families with genetic susceptibility. Researchers are identifying specific genes that contribute to cleft formation.
What to know before you search
Eligibility typically depends on the child's age, whether they've had prior surgery, and the type and severity of the cleft.
What types of trials are currently open
- Surgical technique trials — Comparing different methods of palate repair to see which produces better speech, feeding, and long-term outcomes.
- Timing studies — Testing whether earlier or later surgery leads to better results for speech development and facial growth.
- Bone grafting trials — Evaluating materials and techniques for rebuilding bone in the upper jaw, often needed before permanent teeth come in.
- Prevention studies — Following pregnant women to learn whether vitamins, diet, or avoiding certain exposures reduces cleft risk.
- Long-term follow-up studies — Tracking children into adolescence and adulthood to understand outcomes of different treatment approaches.
Recently added Cleft Palate trials
Share your experience with speech therapy for cleft palate
A cleft (lip and) palate is the most common congenital abnormality of the face and skull with a significant social impact, affecting speech, hearing, feeding, oral behavior, dentition and satisfaction with appearance. These consequences have a long-term and negative impact on social integration and well-being. The World Health Organization (WHO) highlights the significant financial costs, including morbidity, health care costs, emotional distress and social exclusion for patients, their families and society. The purpose of this study is to compare high- and low-intensity speech intervention in children with a cleft (lip and) palate based on the perceptions of the providers of the intervention (primary care speech-language pathologists) and the recipients of the intervention (children with a cleft (lip and) palate and their parents). Individual semi-structured interviews will be conducted with both intervention providers and recipients to explore perceptions and experiences, as well as acceptability of the two speech intervention intensities. Potential participants will be told that the interview will be recorded. The actual interviews will take place at a location and time that is most convenient for the participants. Each interview will be recorded using a Roland R-05 high-quality audio recorder. After conducting the interviews, all participants will be asked to complete a questionnaire regarding their demographics. In addition, data regarding the type of cleft, time and manner of closure of the cleft, any secondary surgery and otological/audiological data will be collected from the medical records of the children with a cleft (lip and) palate. Based on this qualitative study, possible adjustments to the high-intensity therapy protocol can be made. In doing so, these modifications will be relevant to these key stakeholders. This will also facilitate the implementation and widespread use of high-intensity speech therapy in clinical speech therapy practice.
Receive cleft palate surgery with a tissue-healing aid
This prospective, randomized controlled trial evaluates the clinical efficacy of autologous Platelet-Rich Fibrin (PRF) and Gentamicin-Loaded PRF as regenerative and antimicrobial biological adjuncts in primary palatoplasty. A total of 90 pediatric and adolescent patients with unilateral and bilateral complete and incomplete cleft palates will be assigned across three parallel treatment arms: standard palatoplasty alone (control), palatoplasty augmented with standard PRF, and palatoplasty augmented with gentamicin-loaded PRF. The primary objective is to compare quantitative primary mucosal healing scores, wound dehiscence rates, and the incidence of postoperative oronasal fistula formation to determine whether local gentamicin-PRF delivery significantly improves soft-tissue healing and reduces surgical breakdown
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