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

The study is a randomized control studies which aims to contribute data to a previous study
on the effects of ankyloglossia (tongue-tie) on breastfeeding, and to also provide new
information on the effects of maxillary lip-tie on breastfeeding. Participants who are
determined eligible for the study (classified to have ankyloglossia via the HATLFF and
either a Class III or IV maxillary labial frenum) will be randomly assigned to one of two
groups: Group A or Group B. Group A will receive a sham procedure for intervention #1 and a
lingual frenotomy procedure for intervention #2. Group B will receive a lingual frenotomy
procedure for intervention #1 and a sham procedure for intervention #2. Newborns that
continue to have difficulty with breastfeeding after both interventions will undergo
intervention #3, a labial frenotomy, and breastfeeding will be monitored afterwards. These
results will be analyzed to determine when lingual frenotomies, labial frenotomies, or both
are necessary to improve breastfeeding pain and LATCH scores.

The study aims to prove that the simple and low risk frenotomy procedure should be
considered as treatment for both ankyloglossia and maxillary lip-tie, preventing
breastfeeding complications as well as many other future problems such as with speech and
self esteem. It is hypothesized that the use of frenotomies as treatment for ankyloglossia
and maxillary lip-tie will improve breastfeeding success for breastfeeding couplets with
newborns with both ankyloglossia and maxillary lip-tie. It is expected to see an increase in
LATCH score to >7 for breastfeeding sessions and a significant decrease in scoring on the
pain scale after frenotomy intervention, while it is expected to see little change in LATCH
and pain scale assessment scores after sham procedures. Overall data is not expected to vary
significantly between Group A and Group B. It is also hypothesized that a lingual frenotomy
alone will be sufficient to improve breastfeeding success without the need to also conduct a
labial frenotomy.

Inclusion Criteria:

1. Newborn is full term (at least 37 weeks) and otherwise in good health.

2. Newborn exhibits having ankyloglossia (score of less than 11 with failing lactation
management or an appearance score lower than 8, based on HATLFF) and a Class III or
Class IV maxillary lip-tie, simultaneously.

3. Mother of newborn noted to have nipple pain or difficulty with breastfeeding (LATCH
score of <7).

4. Mother of newborn has intention to exclusively breastfeed newborn.

5. Mother of newborn signs a written informed consent for treatment.

Exclusion Criteria:

1. Premature newborns.

2. Newborns older than 2 weeks.

3. Newborns with craniofacial anomalies (i.e. cleft lip or palate).

4. Newborns who are neurologically compromised.

5. Mother has condition that could affect the milk supply (i.e diabetes).

6. Mother of newborn is not English speaking and not able to read at least at a 6th
grade level.