Prospective Evaluation of Lingual Frenotomy in Newborns With Simultaneous Lip Tie for the Relief of Breastfeeding Pain.

NACompletedINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

May 31, 2015

Primary Completion Date

April 30, 2018

Study Completion Date

May 31, 2018

Conditions
AnkyloglossiaBreast FeedingEnlarged Labial Frenum
Interventions
PROCEDURE

Lingual Frenotomy

For newborns receiving the ankyloglossia frenotomy, the tongue will be elevated and the frenulum exposed with a grooved director or 2 cotton tipped applicators. The frenulum tissue will then be incised with a straight scissor. If thick, it will be crushed with a straight clamp to provide anesthesia and decrease bleeding, and the exposed and previously clamped tongue frenulum will be incised with a straight scissor.

PROCEDURE

Labial Frenotomy

For newborns receiving the maxillary labial frenotomy, 0.1 ml of 1% lidocaine will be injected into the area. The upper lip will be lifted and the frenum stretched. Then an iLaseTM 940 ± 15 nm laser will be used to release its attachment to the level of the periosteum.

PROCEDURE

Sham Procedure

For newborns receiving the maxillary labial frenotomy, 0.1 ml of 1% lidocaine will be injected into the area. The upper lip will be lifted and the frenum stretched. Then an iLaseTM 940 ± 15 nm laser will be used to release its attachment to the level of the periosteum.

Trial Locations (1)

33606

Tampa General Hospital, Tampa

All Listed Sponsors
lead

University of South Florida

OTHER

NCT02141243 - Prospective Evaluation of Lingual Frenotomy in Newborns With Simultaneous Lip Tie for the Relief of Breastfeeding Pain. | Biotech Hunter | Biotech Hunter