Breastfeeding Improvement Following Tongue-tie and Lip-tie Release

Sponsor

The Oregon Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT02642133

Collaborator

(none)

237

Enrollment

Arm

Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Ankyloglossia Breastfeeding	Procedure: Lingual Frenotomy and/or maxillary labial frenectomy	N/A

Detailed Description

Breastfeeding rates in the United States initiate at around 80%, but many mothers are unable to effectively breastfeeding because of problems with latch and suction generation. Previous studies have demonstrated how nipple pain is directly linked to ankyloglossia, but most of these studies are done with poor methodology.

Clinically, tongue-tie and lip-tie have correlate with numerous other symptoms besides nipple pain. These babies tend to be inefficient nursers, which can affect weight gain. Abnormal intake of air because of the poor latch/seal can lead to reflux symptoms. Finally, there is a significant psychological toll on mothers who want to breastfeed but cannot do so.

This study aims to prospectively analyze these outcomes by using validated tools.

Study Design

Study Type:

Interventional

Actual Enrollment :

237 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Breastfeeding Improvement Following Tongue-tie and Lip-tie Release: A Prospective Cohort Study

Study Start Date :

Jun 1, 2014

Actual Primary Completion Date :

Mar 1, 2015

Actual Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Other: Intervention All patients were in the same arm - this is a cohort study where the group serves as their own control. Patients who did not undergo the procedure were not included in this outcomes study.	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.

Arm

Intervention/Treatment

Other: Intervention

All patients were in the same arm - this is a cohort study where the group serves as their own control. Patients who did not undergo the procedure were not included in this outcomes study.

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.

Outcome Measures

Primary Outcome Measures

Nipple Pain [1 week]
Using a visual analog scale, nipple pain is evaluated.
Reflux/GERD [1 week]
Using a validated questionnaire (i-GERQ-R)
Breastfeeding efficiency [1 week]
Volume of breastmilk ingested in a specific time frame calculated (mL/min)
Breastfeeding self-efficacy [1 week]
Uses the BSES-SF validated questionnaire

Secondary Outcome Measures

Nipple Pain [1 month]
Using a visual analog scale, nipple pain is evaluated.
Reflux/GERD [1 month]
Using a validated questionnaire (i-GERQ-R)
Breastfeeding self-efficacy [1 month]
Uses the BSES-SF validated questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Day to 12 Weeks

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy babies who are breastfeeding 0-12 weeks of age

Exclusion Criteria:

Serious comorbid conditions (heart, lung, brain)
Prior maternal breast surgery
Insufficient glandular tissue
Previous tongue/lip surgery
Twins/Triplets

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

The Oregon Clinic

Investigators

Principal Investigator: Bobak A Ghaheri, MD, The Oregon Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Bobak Ghaheri, MD, Otolaryngologist, The Oregon Clinic

ClinicalTrials.gov Identifier:

NCT02642133

Other Study ID Numbers:

TOC ENT

First Posted:

Dec 30, 2015

Last Update Posted:

Dec 30, 2015

Last Verified:

Dec 1, 2015

Additional relevant MeSH terms:

Ankyloglossia

Study Results

No Results Posted as of Dec 30, 2015