Frenotomy of the Labial Frenulum in Infants With Breastfeeding Difficulties

Effect of Labial Frenulum Clipping on Nipple Pain and Latch Problems in Breastfeeding Infants

Status

Suspended

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00970255

Enrollment

Registered

2009-09-02

Start date

2009-10-31

Completion date

Unknown

Last updated

2012-08-02

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

Conditions

Breastfeeding

Keywords

Breastfeeding difficulties, lingual frenulum, labial frenulum, frenotomy

Brief summary

Upper lingual frenulum have been implicated as a cause for pain during breastfeeding and latch problems. The investigators hypothesize that performing frenotomy of the frenulum may improve breastfeeding. The investigators will include breastfeeding infants with pain or latch problems in whom the lingual frenulum had been treated but breastfeeding problems were not resolved. The investigators plan to study the effect of frenotomy of the upper lingual frenulum on maternal pain (using pain score by visual analog scale) and/or latch score.

Interventions

PROCEDURELingual Frenulum frenotomy

Clipping the lingual frenulum with scissors

PROCEDURESham frenotomy

Sham Clipping the lingual frenulum with scissors

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

No minimum to 6 Months

Healthy volunteers

Yes

Inclusion criteria

* breastfeeding infants * maternal nipple pain * latching problems

Exclusion criteria

* oral cavity anomalies * breast anatomical anomalies * untreated tongue-tie in infant

Design outcomes

Primary

Measure	Time frame
Pain score by Visual Analog Scale	Within 30 minutes
Latch Score	Within 30 Minutes

Countries

Israel

Outcome results

None listed

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