Manual manipulation after frenotomy for infants with tongue tie
Official title: Effectiveness of Post-Procedural Manual Manipulation for Infant Ankyloglossia in Enhancing Breastfeeding and Reducing Revision Rates: A Prospective Randomized Trial
Run by Georgetown University · NCT06830148 · Data updated 2026-11-12
This study is testing if tongue stretching and suck re-training exercises after a tongue tie surgery can help infants breastfeed better and prevent the tongue tie from coming back.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | Any age to 90 Days |
| Sex | All |
| Enrollment | 110 (estimated) |
| Sponsor | Georgetown University Academic / other |
| Locations | 1 site (Washington D.C., District of Columbia) |
| Status | Recruiting |
| Started | October 15, 2024 |
| Main results expected | October 2025 |
| Study ends | November 2025 |
| Registry record updated | February 17, 2025 |
| Trial ID | NCT06830148 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are infants under 90 days old with ankyloglossia who are exclusively or partially breastfed.
✕Probably not a fit
Patients who are older than 90 days, exclusively bottle-fed, or have undergone previous frenotomy procedures may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to evaluate the effectiveness of post-frenotomy manual manipulation in infants diagnosed with ankyloglossia. Infants undergoing frenotomy will be randomly assigned to either an intervention group, which will perform tongue stretching and suck re-training exercises, or a control group with no intervention. The study will assess the impact of these exercises on the rates of frenulum regrowth and breastfeeding outcomes. Follow-up assessments will be conducted to monitor adherence and any complications.
Why it matters
Potential benefit: If successful, this approach could significantly improve breastfeeding outcomes for infants with ankyloglossia.
How similar studies have gone: While similar approaches have been explored, this specific intervention's effectiveness remains to be fully validated.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * infants less than 90 days old with ankyloglossia who undergo outpatient frenotomy using cold-steel scissors and will be exclusively or partially breastfed. Exclusion Criteria: * 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. * 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
Where it's running
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MedStar Georgetown University Hospital, Department of Otolaryngology-Head and Neck Surgery
Washington D.C., District of Columbia, United States Recruiting
Study contacts
- Principal investigator: Earl H Harley, MD — MedStar Georgetown University Hospital
- Study coordinator: Emily A Clementi, BA
- Email: eac166@georgetown.edu
- Phone: (202) 444-8186
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Post-Frenotomy Massages After Tongue-Tie Procedure
After a frenotomy, this study tests whether giving babies sublingual massages reduces tongue-tie recurrence and improves feeding.
-
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Tongue-strengthening exercises to help speech clarity with P1821
This study tests whether a home-based tongue-strengthening program using the P1821 device can improve speech fluency in people with tongue-related speech impairments.
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940 nm diode laser versus electrosurgery for tongue‑tie release in children aged 3–6
This trial will test whether a 940 nm diode laser or conventional electrosurgery leads to faster healing, less pain, and better tongue movement for children aged 3 to 6 with tongue‑tie.
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Peer-support breastfeeding program for mothers facing severe socioeconomic hardship
This project will try a peer-support breastfeeding program to help mothers in severe socioeconomic deprivation who plan to breastfeed their hospitalized infants.
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Pregnancy and postpartum breastfeeding support for people with gestational diabetes
This project will try a co-designed breastfeeding support program for pregnant and postpartum people with gestational diabetes to help lower their future risk of type 2 diabetes.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.