TABLE 1.

Studies examining the effectiveness of frenotomy in infants with ankyloglossia and breastfeeding (BF) difficulties

Authors (reference), year	Study type	Study population	Definition of ankyloglossia	Methods	Outcome measures	Results
Hogan et al (6), 2005	Randomized controlled trial	57 infants with ankyloglossia and feeding difficulties (breast or bottle) Mean age at randomization: 20 days	Percentage of tongue-tie gauged by eye, ranging from 100% (ie, to the tip) to 25%	Randomly assigned to frenotomy or control (advice) If no improvement noted in conservative group after 48 h, frenotomy offered	Telephone interview with mother at 24 h, weekly for four weeks and at four months Latching problems Sore nipples Continuous feeds Top-up feeds	27/28 infants randomly assigned to the frenotomy group improved their symptoms after procedure compared with 1/29 in control group 28/29 infants in control group underwent frenotomy Mothers of 27/28 of these infants had improvement in symptoms
Dollberg et al (20), 2006	Randomized, masked prospective study	25 infants (one to 21 days of age) with ankyloglossia and mothers with sore nipples	The inability of the infant to protrude the tip of the tongue over the lower gum line while the tip was tied to the floor of the mouth by a tight cord of frenulum, and the tongue became heart-shaped when lifted up”	Randomized to one of two sequences: Frenotomy, BF, sham, BF (14 infants), or sham, BF, frenotomy, BF (11 infants)	After the first procedure (frenotomy or sham), a standardized LATCH score (21) was assessed and a pain scale assessment (1 to 10) was obtained from the mother	Maternal pain score decreased from 7.1 to 5.3 (CI overlap) after frenotomy and insignificant increase in LATCH score
Berry et al (22), 2012	Randomized, double-blinded controlled trial	60 breastfed infants (mean age 32 days) with BF problem (defined as difficulty with latch, nipple pain/trauma or inefficient feeding) and ankyloglossia	“Tongue-tie was present”	Randomized to immediate frenotomy (30 infants) or nonfrenotomy (30 infants)	Preprocedure: LATCH scoring and Infant Breastfeeding Assessment Tool (IBFAT) (23) and maternal pain score (1 to 10) during the sample feed Postprocedure: (First feed reportedly blinded): Objective assessment as above Subjective maternal assessment and pain score (1 to 10) Telephone call at one day and three months for subjective change in feeding, complications and BF rates	21/27 (78%) of mothers in frenotomy group reported subjective improvement following procedure compared with 14/30 (47%) of infants in control group Objective observer reported no statistical significance in feeding (50% improved in frenotomy group versus 40% in control group) 30 infants in nonfrenotomy group later underwent procedure At three months after frenotomy, 56% (33/59) reported full resolution, and 8% (5/59) no improvement BF rate at three-month follow-up was 51%
Emond et al (24), 2014	Randomized controlled trial	107 term infants (median age 11 days) with a mild or moderate degree of tongue-tie and difficulties with BF (defined by LATCH score ≤8)	Hazelbaker Assessment Tool for Lingual Frenulum Function Score (HATLFF) 6–12	Randomized to immediate frenotomy or standard care	Primary outcome: LATCH score at five days Secondary outcomes: LATCH score at eight weeks and the Infant Breast Feeding Assessment Tool score at five days and eight weeks, Breastfeeding Self-Efficacy Score – Short Form (BSES-SF) (25) and pain scale (1 to 10) at five days and eight weeks and infant weight at eight weeks	At five days, HATLFF score had increased in frenotomy group, but no difference in IBFAT, LATCH score or BSES-SF and pain 35/53 of control group offered frenotomy after five days No difference in any BF assessments or infant weight at eight weeks between groups BF rates of 80% in both groups at eight weeks
Ballard et al (8), 2002	Cohort study	Recruited 127 (of 3036 examined term infants inpatient and outpatient) with ankyloglossia	HATLFF function score >11/14 in the presence of an appearance score <8/10	123 infants underwent frenotomy (four mothers declined the procedure)	Latch not measured quantitatively; subjective by evaluators and mother Maternal nipple pain score (1 to 10)	Ankyloglossia accounted for 35/273 (12.8%) of BF problems seen at outpatient clinic Mean HATLFF scores similar for presenting features of poor latch and nipple pain Maternal nipple pain decreased postprocedure (6.9 to 1.2)
Buryk et al (26), 2011	Randomized, single-blinded controlled trial	Infants with difficulty with BF and significant ankyloglossia (randomized at mean age of six days)	HATLFF function score >11/14 with failing lactation management or an appearance score <8/10	Randomized to frenotomy (30 infants) or a sham procedure (28 infants)	BF assessed pre- and postintervention Short-Form McGill Pain Questionnaire (SF-MPQ) (27) nipple pain scale and IBFAT and at two weeks and regular follow-ups Secondary outcome of effect of frenotomy on length of BF	Both groups had statistically significant decreased nipple pain scores after the intervention IBFAT score not significantly different between frenotomy and control groups postintervention 27/28 infants in sham group underwent frenotomy at or before time of two-week follow-up No difference in duration of BF Maternal subjective report of improved latch postfrenotomy