Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

150

participants targeted

Target at P75+ for not_applicable

Timeline

9mo left

Started Jan 2025

Typical duration for not_applicable

Geographic Reach

1 country

1 active site

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2.3 years study duration

Study Progress67%

Jan 2025May 2027

Study Start

First participant enrolled

January 27, 2025

Completed

1.5 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2026

Completed

5 days until next milestone

First Posted

Study publicly available on registry

July 31, 2026

Completed

7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

July 31, 2026

Status Verified

July 1, 2026

Enrollment Period

2.1 years

First QC Date

July 26, 2026

Last Update Submit

July 26, 2026

Conditions

Ankyloglossia

Keywords

FrenotomyAnkyloglossia

Outcome Measures

Primary Outcomes (1)

Ankyloglossia Recurrence
The primary outcome was the recurrence of ankyloglossia (tongue-tie) upon two month follow-up as defined by the Hazelbaker Assessment Tool for Lingual Frenulum Function.
From enrollment to follow-up at 8 weeks.

Secondary Outcomes (1)

Feeding Experience
From enrollment to follow-up at 8 weeks.

Study Arms (2)

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/guardians 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/guardians will be instructed to keep a log of any missed sessions to bring with them upon follow-up.

Other: Post-frenotomy massage

Control Arm

NO INTERVENTION

Participants in this arm will not undergo any massages under their tongues. Parents/guardians will be instructed not to touch the operative site and to allow the natural motion of tongue while the infant feeds.

Interventions

Post-frenotomy massageOTHER

Participants receiving this intervention will undergo massages under their tongues after the frenotomy (e.g., tongue-tie cutting procedure) is completed. Parents/guardians 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/guardians will be instructed to keep a log of any missed sessions to bring with them upon follow-up.

Massage Arm

Eligibility Criteria

AgeUp to 1 Year

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

Neonates (age \<1 year) who were undergoing frenotomy procedure are eligible.

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Isaac Elijahlead

Study Sites (1)

ENT Specialists

Boynton Beach, Florida, 33437, United States

RECRUITING

Related Publications (1)

1. Becker S, Brizuela M, Mendez MD. Ankyloglossia (Tongue-Tie) [Updated 2023 Jun 9]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK482295/ 2. Hill, R.R., Lee, C.S. & Pados, B.F. The prevalence of ankyloglossia in children aged <1 year: a systematic review and meta-analysis. Pediatr Res 90, 259-266 (2021). https://doi.org/10.1038/s41390-020-01239-y 3. Cordray H, Mahendran GN, Tey CS, Nemeth J, Sutcliffe A, Ingram J, Raol N. Severity and prevalence of ankyloglossia-associated breastfeeding symptoms: A systematic review and meta-analysis. Acta Paediatr. 2023 Mar;112(3):347-357. doi: 10.1111/apa.16609. Epub 2022 Dec 9. PMID: 36437565. 4. Ballard JL, Auer CE, Khoury JC. Ankyloglossia: Assessment, incidence, and effect of frenuloplasty on the breastfeeding dyad. Pediatrics. 2002;110(5):e63. doi: 10.1542/peds.110.5.e63. 5. Messner, A.H., Walsh, J., Rosenfeld, R.M., Schwartz, S.R., Ishman, S.L., Baldassari, C., Brietzke, S.E., Darrow, D.H., Goldstein, N., Levi, J., Meyer, A.K., Parikh, S., Simons, J.P., Wohl, D.L., Lambie, E. and Satterfield, L. (2020), Clinical Consensus Statement: Ankyloglossia in Children. Otolaryngology-Head and Neck Surgery, 162: 597-611. https://doi.org/10.1177/0194599820915457 6. Bhandarkar, K.P., Dar, T., Karia, L. et al. Post Frenotomy Massage for Ankyloglossia in Infants-Does It Improve Breastfeeding and Reduce Recurrence?. Matern Child Health J 26, 1727-1731 (2022). https://doi.org/10.1007/s10995-022-03454-x 7. Dinh LA, El-Rabbany M, Aslam S, Ricalde P. Does Lingual Frenotomy Improve Breastfeeding in Newborns With Ankyloglossia? A Randomized Controlled Trial. J Oral Maxillofac Surg. 2025 Jul;83(7):806-812. doi: 10.1016/j.joms.2025.04.006. Epub 2025 Apr 16. PMID: 40319911. 8. Bruney TL, Scime NV, Madubueze A, Chaput KH. Systematic review of the evidence for resolution of common breastfeeding problems-Ankyloglossia (Tongue Tie). Acta Paediatr. 2022 May;111(5)
BACKGROUND

MeSH Terms

Conditions

Ankyloglossia

Condition Hierarchy (Ancestors)

Stomatognathic Diseases

Central Study Contacts

David L Mandell, MD

CONTACT

(561) 736-8141 dlm789@gmail.com

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: NONE
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR INVESTIGATOR
PI Title: Co-investigator

Study Record Dates

First Submitted

July 26, 2026

First Posted

July 31, 2026

Study Start

January 27, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

July 31, 2026

Record last verified: 2026-07

Locations

US(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Massage Arm

Control Arm

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

Locations