An interventional study of Lingual Frenotomy and/or maxillary labial frenectomy in Ankyloglossia and Breastfeeding, sponsored by The Oregon Clinic. Completed. Open to participants aged 1 Day to 12 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-12-30.
Sponsored by The Oregon Clinic · Not applicable, Interventional, and Treatment
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.
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.
32 studies on the registry are indexed under Ankyloglossia; 8 are open to participants now.
This study's enrollment of 237 is above the median of 105 across 22 interventional studies indexed under Ankyloglossia.
Browse Ankyloglossia studies →The Oregon Clinic is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
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.
Nipple Pain
Using a visual analog scale, nipple pain is evaluated.
Time frame: 1 week
Reflux/GERD
Using a validated questionnaire (i-GERQ-R)
Time frame: 1 week
Breastfeeding efficiency
Volume of breastmilk ingested in a specific time frame calculated (mL/min)
Time frame: 1 week
Breastfeeding self-efficacy
Uses the BSES-SF validated questionnaire
Time frame: 1 week
Nipple Pain
Using a visual analog scale, nipple pain is evaluated.
Time frame: 1 month
Reflux/GERD
Using a validated questionnaire (i-GERQ-R)
Time frame: 1 month
Breastfeeding self-efficacy
Uses the BSES-SF validated questionnaire
Time frame: 1 month
No study locations are listed for this record.
This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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