[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ankyloglossia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ankyloglossia":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,45,72,99,132],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100651310","ankyloglossia-and-breastfeeding-100651310",false,"NCT07757503","Ankyloglossia and Breastfeeding","THE EFFECT OF ANKYLOGLOSIA ON BREASTFEEDING: A COHORT STUDY","Inclusion Criteria:\n\n* Mother-infant dyads recruited during the newborn's first 72 hours of life, during the hospital admission for childbirth at the University Hospital of Guadalajara.\n* Singleton pregnancy.\n* Gestational age at birth between 37 weeks and 41 weeks and 6 days.\n* Maternal intention to provide exclusive or mixed breastfeeding.\n* Written informed consent provided by the parent or legal guardian.\n\nExclusion Criteria:\n\n* Birth outside the University Hospital of Guadalajara.\n* Preterm birth (\\\u003C37 weeks of gestation).\n* Fetal or neonatal pathology diagnosed before or after birth.\n* Admission to the neonatal unit after birth or during the hospital stay.\n* Any contraindication to breastfeeding.\n* Language barriers preventing communication in Spanish with the parents or legal guardians.\n* Withdrawal of informed consent.\n* Loss to follow-up.",true,"ALL","72 Hours",{"count":20,"type":21},146,"ESTIMATED","OBSERVATIONAL","Ankyloglossia is a congenital condition characterized by a restrictive lingual frenulum that may limit normal tongue mobility and be associated with breastfeeding difficulties. Reported problems include ineffective latch, maternal nipple pain and nipple trauma, mastitis, reduced milk transfer, poor infant weight gain, and early breastfeeding cessation. However, the available evidence regarding the impact of ankyloglossia on breastfeeding outcomes remains limited and controversial.\n\nThe primary objective of this prospective cohort study is to evaluate the association between neonatal ankyloglossia, assessed using the TABBY assessment tool during the first 72 hours of life, and breastfeeding effectiveness measured using the LATCH scale during the same period.\n\nMother-infant dyads will be recruited during the newborn's first 72 hours of life, during the hospital admission for childbirth, at the University Hospital of Guadalajara, Spain. Newborns will be classified according to the presence or absence of ankyloglossia using the TABBY assessment tool and will be followed for the first 6 months of life. Information will be collected during routine clinical follow-up and through telephone interviews.\n\nThe secondary objectives are to evaluate the association between ankyloglossia and breastfeeding duration, exclusive breastfeeding duration, maternal pain during breastfeeding, and maternal breastfeeding satisfaction.",[25,26],"Ankyloglossia","Breastfeeding",[25,28,26,29,30,31],"Tongue-tie","Breastfeeding effectiveness","TABBY Tongue-tie and Breastfed Babies","LATCH Breastfeediing assessment","NOT_YET_RECRUITING","2026-08-06",{"date":35,"type":36},"2026-08-11","ACTUAL",{"date":38,"type":21},"2026-09",{"date":40,"type":21},"2028-12",{"name":42,"class":43},"Ariana Muñoz San Miguel","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":60,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":44},"100649729","the-impact-of-post-frenotomy-massages-on-ankyloglossia-recurrence-and-feeding-outcomes-100649729","NCT07738185","The Impact of Post-Frenotomy Massages on Ankyloglossia Recurrence and Feeding Outcomes","The Impact of Post-Frenotomy Massages on Ankyloglossia Recurrence and Feeding Outcomes: A Prospective Randomized Trial","Inclusion Criteria:\n\n* Neonates (age \\\u003C1 year) who were undergoing frenotomy procedure are eligible.\n\nExclusion Criteria:\n\n* Patients will be excluded if they were older than 1 year, or had palatal or oropharyngeal conditions that may present confounding effects on their ability to feed, including cleft lip and cleft palate.","1 Year",{"count":54,"type":21},150,"INTERVENTIONAL",[57],"NA","This purpose of this study is to investigate whether performing sublingual massages after frenotomy reduces the recurrence of ankyloglossia (e.g., \"tongue-tie\". After consent from the parents or guardians, infants who received underwent frenotomy will be randomized to either complete sublingual massages according to a specified description and schedule, or they will be randomized to the control group where they will be instructed to perform no massages. The main question to answer is do these massages reduce the likelihood of tongue-tie recurrence or not. Secondary question is will there be any significant difference on feeding practice or experience in infants who undergo massages compared to those who do not.",[25],[61,25],"Frenotomy","RECRUITING","2026-07-31",{"date":65,"type":36},"2026-08-03",{"date":67,"type":36},"2025-01-27",{"date":69,"type":21},"2027-05",{"name":71,"class":43},"Isaac Elijah",{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":16,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":55,"phases":80,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":44},"100648356","effectivity-of-p1821-a-novel-tongue-strengthening-and-endurance-enhancing-speech-flow-exercise-100648356","NCT07719582","Effectivity of P1821, a Novel Tongue Strengthening and Endurance Enhancing Speech Flow Exercise","Inclusion Criteria:\n\n* Can read and write\n* Willing and able to follow the requirements of the protocol\n\nExclusion Criteria:\n\n* Previously seen and treated by speech and language pathologist for dysphagia or dysarthria for non-head and neck cancer causes\n* Medical instability, restlessness, or other factors that would compromise data acquisition",{"count":79,"type":21},100,[57],"The P1821 initiative constitutes an innovative intervention specifically engineered to enhance tongue muscular strength and endurance. The primary objective of this research study is to ascertain whether the integration of a proactive tongue strengthening exercise regimen, utilizing a Non-Significant Risk (NSR) Device, contributes to an observable improvement in speech fluency.",[25,83,84],"Impairment of Speech","Slurred Speech",[86,87,88,89],"Tongue-strengthening self-exercises (TSsE)","Tongue strength","Home-based exercise","Self-exercise","2026-07-18",{"date":92,"type":36},"2026-07-22",{"date":94,"type":21},"2028-01-01",{"date":96,"type":21},"2030-01-01",{"name":98,"class":43},"Dream Video LLC",{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":17,"minAge":106,"maxAge":107,"enrollmentInfo":108,"targetDuration":4,"studyType":55,"phases":110,"briefSummary":111,"conditions":112,"keywords":113,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":131},"100635837","healing-efficacy-of-diode-laser-in-lingual-frenectomy-100635837","NCT07557875","Healing Efficacy of Diode Laser in Lingual Frenectomy","Evaluation of the Healing Efficacy of Diode Laser in Lingual Frenectomy","Inclusion Criteria:\n\n* Patients aged between 3 and 6 years.\n* Diagnosed with grade 3 or grade 4 ankyloglossia according to Kotlow's classification (1999).\n* Parents or legal guardians provide informed consent for the child to participate in the study.\n* Patients and guardians agree to follow the follow-up schedule (24 hours, 3 days, 1 week, and 1 month post-surgery).\n\nExclusion Criteria:\n\n* History of allergy to local anesthetics (e.g., Lidocaine, Adrenaline).\n* Patients with systemic diseases or high-risk surgical factors (e.g., cardiovascular disease, bleeding disorders, hemophilia, epilepsy, or uncontrolled asthma).\n* Uncooperative patients who are unable to undergo the procedure under local anesthesia or fail to follow post-operative instructions.\n* Patients who withdraw from the study before completion.","3 Years","6 Years",{"count":109,"type":21},53,[57],"This study aims to compare the wound healing efficacy and postoperative experiences between the 940 nm diode laser technique and the traditional electrosurgery method for treating ankyloglossia (tongue-tie) in children aged 3 to 6 years.\n\nParticipants are randomly assigned to one of two groups: Experimental Group - Patients undergo lingual frenectomy using a 940 nm diode laser and Active Comparator Group - Patients undergo the procedure using conventional high-frequency electrosurgery.\n\nThe study evaluates several key outcomes at multiple intervals (24 hours, 3 days, 1 week, and 1 month post-surgery), including: (1) Wound Healing: Measured by the Early Wound Healing Score (EHS); (2) Pain Levels: Assessed using the Wong-Baker FACES Pain Rating Scale; (3) Bleeding Control: Evaluation of intraoperative bleeding; (4) Tongue Mobility: Measurement of free tongue length according to Kotlow's classification.\n\nThe goal is to determine if the diode laser provides superior healing, less pain, and better bleeding control compared to electrosurgery.",[25,28],[25,28,114,115,116,117,118,119,120,121],"Lingual frenectomy","Diode laser","Electrosurgery","Wound healing","Postoperative pain","Early Wound Healing Score (EHS)","Wong-Baker FACES Pain Rating Scale","Kotlow's classification","2026-04-22",{"date":124,"type":36},"2026-04-30",{"date":126,"type":36},"2024-10-01",{"date":128,"type":21},"2026-10-01",{"name":130,"class":43},"University of Medicine and Pharmacy at Ho Chi Minh City",2,{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":139,"enrollmentInfo":140,"targetDuration":4,"studyType":55,"phases":142,"briefSummary":143,"conditions":144,"keywords":146,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":44},"100579888","post-procedural-manual-manipulation-for-infant-ankyloglossia-100579888","NCT06830148","Post-Procedural Manual Manipulation for Infant Ankyloglossia","Effectiveness of Post-Procedural Manual Manipulation for Infant Ankyloglossia in Enhancing Breastfeeding and Reducing Revision Rates: A Prospective Randomized Trial","Inclusion Criteria:\n\n* infants less than 90 days old with ankyloglossia who undergo outpatient frenotomy using cold-steel scissors and will be exclusively or partially breastfed.\n\nExclusion Criteria:\n\n* infants older than 90 days, those who will be exclusively bottle fed, infants who undergo concomitant lip tie release, those who undergo laser frenotomy, and infants who have previously undergone a frenotomy.\n* infants with a gestational age of less than 36 weeks, those in the NICU or post-partum unit, infants who didn't receive the vitamin K injection, and those with congenital anomalies or medical conditions affecting breastfeeding","90 Days",{"count":141,"type":21},110,[57],"The goal of this randomized control trial is to determine the impact of post-frenotomy manual manipulation on revision rates and breastfeeding outcomes. We hypothesize that post-frenotomy manipulation will reduce the rate of sublingual frenulum regrowth, and subsequently frenotomy revision rates, thereby improving breastfeeding performance.\n\nInfants with ankyloglossia undergoing frenotomy will be randomized into two groups: the intervention group (post-frenotomy manipulation) and the control group (no intervention). Parents in the intervention group will be instructed to perform tongue stretching and suck \"re-training\" exercises four times daily for 2-3 weeks, beginning 24 hours post-procedure. To monitor adherence and assess any complications, investigators will conduct a follow-up phone call one week after the procedure. Parents in the control group will not be instructed to perform any post-procedural manipulation. All participants will have a mandatory in-person follow-up 2-3 weeks postoperatively, during which breastfeeding outcomes and the need for frenotomy revision will be evaluated.",[25,145],"Breastfeeding Support",[147,148,149,150,151,152],"tongue tie","breastfeeding","exercises","infant","pediatric otolaryngology","frenotomy","2025-02-11",{"date":155,"type":36},"2025-02-17",{"date":157,"type":36},"2024-10-15",{"date":159,"type":21},"2025-11",{"name":161,"class":43},"Georgetown University"]