[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649729":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":24,"locations":30,"responsibleParty":50,"collaborators":18,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":18,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":18,"maxAge":62,"enrollmentInfo":63,"targetDuration":18,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":33,"whyStopped":18,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Florida Atlantic University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Massage Arm","EXPERIMENTAL","Participants randomized to this arm will undergo massages under their tongues after the frenotomy (e.g., tongue-tie cutting procedure) is completed. Parents\u002Fguardians will be instructed to wait until postoperative day one before initiating massages. They will be instructed to then perform massages twice per day for seven days by applying gentle pressure with the fingertip in a circular motion around the frenotomy site for at least 10 seconds at a time with the intention of disrupting any developing connective tissue or ankyloglossia recurrence. The parents\u002Fguardians will be instructed to keep a log of any missed sessions to bring with them upon follow-up.",[13],"Other: Post-frenotomy massage",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Arm","NO_INTERVENTION","Participants in this arm will not undergo any massages under their tongues. Parents\u002Fguardians will be instructed not to touch the operative site and to allow the natural motion of tongue while the infant feeds.",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":18},"Post-frenotomy massage","Participants receiving this intervention will undergo massages under their tongues after the frenotomy (e.g., tongue-tie cutting procedure) is completed. Parents\u002Fguardians will be instructed to wait until postoperative day one before initiating massages. They will be instructed to then perform massages twice per day for seven days by applying gentle pressure with the fingertip in a circular motion around the frenotomy site for at least 10 seconds at a time with the intention of disrupting any developing connective tissue or ankyloglossia recurrence. The parents\u002Fguardians will be instructed to keep a log of any missed sessions to bring with them upon follow-up.",[9],[25],{"name":26,"role":27,"phone":28,"phoneExt":18,"email":29},"David L Mandell, MD","CONTACT","(561) 736-8141","dlm789@gmail.com",[31],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"ENT Specialists","RECRUITING","Boynton Beach","Florida","33437","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-80.06643,26.52535,{"lat":43,"lon":42},[46,47],{"name":26,"role":27,"phone":28,"phoneExt":18,"email":29},{"name":48,"role":49,"phone":18,"phoneExt":18,"email":18},"Isaac Elijah, BS","SUB_INVESTIGATOR",{"type":51,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"SPONSOR_INVESTIGATOR","Isaac Elijah","Co-investigator","100649729","the-impact-of-post-frenotomy-massages-on-ankyloglossia-recurrence-and-feeding-outcomes-100649729",false,"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.","ALL","1 Year",{"count":64,"type":65},150,"ESTIMATED","INTERVENTIONAL",[68],"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.",[71],"Ankyloglossia",[73,71],"Frenotomy","2026-07-31",{"date":76,"type":77},"2026-08-03","ACTUAL",{"date":79,"type":77},"2025-01-27",{"date":81,"type":65},"2027-05",{"name":52,"class":6},1]