Anterior Lingual Frenectomy is Inadequate in Improving Breastfeeding Outcomes: a Prospective Cohort Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02936518

Enrollment

Registered

2016-10-18

Start date

2014-06-30

Completion date

2017-06-30

Last updated

2017-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankyloglossia, Breastfeeding

Keywords

ankyloglossia, breastfeeding, lip tie

Brief summary

A previously published study (https://www.ncbi.nlm.nih.gov/pubmed/27641715) identified breastfeeding improvements following lingual frenotomy and/or maxillary labial frenectomy. In the previous cohort, babies were excluded from the study if they had previously undergone an attempted frenotomy prior to seeing the P.I. in the office. The proposed study will only look at those babies who did undergo a previous frenotomy to determine: 1. the presence of continued problematic breastfeeding symptoms 2. if further tongue tie or lip tie release improves those outcomes

Interventions

PROCEDURELingual frenotomy and/or maxillary labial frenectomy

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Days to 8 Months

Healthy volunteers

Yes

Inclusion criteria

* Healthy babies who are breastfeeding * Had a previous frenotomy prior to presenting to the P.I.

Exclusion criteria

* Twins, triplets * Maternal breast surgery or IGT * Premature birth * Significant heart/lung/brain disease of infant

Design outcomes

Primary

Measure	Time frame
Maternal breastfeeding self-efficacy (BSES-SF)	1 week and 1 month post-procedure
Nipple pain	1 week post-procedure
Reflux (i-GERQ-R)	1 week and 1 month post-procedure

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026