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Breastfeeding Improvement Following Tongue-tie and Lip-tie Release

NCT02642133 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 237

Last updated 2015-12-30

No results posted yet for this study

Summary

This study is an observational study to determine outcomes of surgical release of tongue-tie and lip-tie in babies who are experiencing difficulty with breastfeeding.

Conditions

  • Ankyloglossia
  • Breastfeeding

Interventions

PROCEDURE

Lingual Frenotomy and/or maxillary labial frenectomy

The procedure is performed with a 1064nm InGaAsP semiconductor diode laser which is a soft tissue laser with variable pulsed wave and wattage settings. The procedure was performed at 0.7-0.8 pulsed watts, 200 microseconds on and 100 microseconds off (actual wattage: 0.47 to 0.53 W) using a 300 micron laser fiber. The tongue is elevated using a grooved director while the laser tip is applied to the frenulum. If present, the anterior frenulum is divided until the submucosal portion of the tie is identified (this is the posterior tongue-tie). A small window in the central mucosa is made and the lateral mucosal walls of the posterior tongue-tie are released, taking care to not disturb the fascia of the underlying genioglossus muscle.

Sponsors & Collaborators

  • The Oregon Clinic

    lead OTHER

Principal Investigators

  • Bobak A Ghaheri, MD · The Oregon Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Day
Max Age
12 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2015-03-31
Completion
2015-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02642133 on ClinicalTrials.gov